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Objectives: The aim of the current study was to investigate the health-related quality of life (HRQol) of the family caregiver in MCI, explore possible determinants and study possible differences with mild dementia., Methods: This secondary data analysis included 145 persons with MCI and 154 persons with dementia and their family caregivers from two Dutch cohort studies. HRQoL was measured with the VAS of the EuroQol-5D-3L version. Regressions analyses were conducted to examine potential demographic and clinical determinants of the caregiver's HRQoL., Results: The mean EQ5D-VAS in family caregivers of persons with MCI was 81.1 (SD 15.7), and did not significantly differ from family caregivers in mild dementia (81.9 (SD 13.0)). In MCI, patient measurements were not significantly associated with caregiver mean EQ5D-VAS. Concerning caregiver characteristics, being a spouse and a lower educational level were associated with a lower mean EQ5D-VAS (in a multiple linear regression model: unstandardized B -8.075, p  = 0.013 and unstandardized B -6.162, p  = 0.037 resp.). In mild dementia, the NPI item irritability showed an association with caregiver EQ5D-VAS in bivariate linear regression analyses., Conclusion: Results indicate that especially family caregiver characteristics seem to influence family caregiver HRQoL in MCI. Future research should include other potential determinants such as burden, coping strategies and relationship quality.

Objectives: Informal caregiving is becoming increasingly important in dementia care, but causes a considerable burden on caregivers which impacts their wellbeing. We aimed to develop and pilot test a digital monitoring tool (REsilience Monitor for INformal caregivers in Dementia [REMIND]) for wellbeing and resilience of informal caregivers to provide timely support and thereby prevent their overburden and eventually crises admissions of persons with dementia., Methods: A human-centered design method based on co-creation with informal caregivers and professionals was used to design REMIND. During co-creation meetings and in-between sprint sessions, a point of focus was formulated, and a prototype was created. Case manager-caregiver duos pilot-tested REMIND for 3 months. Semi-structured interviews were conducted to determine usability and acceptability. Thematic analysis was applied to the transcripts., Results: Informal caregivers and professionals with varying backgrounds participated in three co-creation meetings. Defined point of focus was to develop a tool that is able to provide insight into the experienced burden of informal caregivers. The REMIND prototype consisted of weekly questions about wellbeing and resilience for informal caregivers and a dashboard with answers for case managers. Eight case managers and 13 informal caregivers considered REMIND easy-to-use. Informal caregivers mentioned that REMIND stimulated self-reflection. Case managers appreciated the tool's ability to gain insight in the actual wellbeing of informal caregivers., Conclusions: The REMIND tool developed in co-creation with end-users potentially increases insight in actual wellbeing of informal caregivers for both caregivers and case managers. A long-term (controlled) follow-up study is needed to evaluate REMIND's impact on caregiver burden and crisis admissions., (© 2023 The Authors. International Journal of Geriatric Psychiatry published by John Wiley & Sons Ltd.)

Background: Society is facing a global shortage of 17 million health care workers, along with increasing health care demands from a growing number of older adults. Social robots are being considered as solutions to part of this problem., Objective: Our objective is to evaluate the quality of care perceived by patients and caregivers for an integrated care pathway in an outpatient clinic using a social robot for patient-reported outcome measure (PROM) interviews versus the currently used professional interviews., Methods: A multicenter, two-parallel-group, nonblinded, randomized controlled trial was used to test for noninferiority of the quality of care delivered through robot-assisted care. The randomization was performed using a computer-generated table. The setting consisted of two outpatient clinics, and the study took place from July to December 2019. Of 419 patients who visited the participating outpatient clinics, 110 older patients met the criteria for recruitment. Inclusion criteria were the ability to speak and read Dutch and being assisted by a participating health care professional. Exclusion criteria were serious hearing or vision problems, serious cognitive problems, and paranoia or similar psychiatric problems. The intervention consisted of a social robot conducting a 36-item PROM. As the main outcome measure, the customized Consumer Quality Index (CQI) was used, as reported by patients and caregivers for the outpatient pathway of care., Results: In total, 75 intermediately frail older patients were included in the study, randomly assigned to the intervention and control groups, and processed: 36 female (48%) and 39 male (52%); mean age 77.4 years (SD 7.3), range 60-91 years. There was no significant difference in the total patient CQI scores between the patients included in the robot-assisted care pathway (mean 9.27, SD 0.65, n=37) and those in the control group (mean 9.00, SD 0.70, n=38): P=.08, 95% CI -0.04 to 0.58. There was no significant difference in the total CQI scores between caregivers in the intervention group (mean 9.21, SD 0.76, n=30) and those in the control group (mean 9.09, SD 0.60, n=35): P=.47, 95% CI -0.21 to 0.46. No harm or unintended effects occurred., Conclusions: Geriatric patients and their informal caregivers valued robot-assisted and nonrobot-assisted care pathways equally., Trial Registration: ClinicalTrials.gov NCT03857789; https://clinicaltrials.gov/ct2/show/NCT03857789., (©Roel Boumans, Fokke van Meulen, William van Aalst, Joyce Albers, Marèse Janssen, Marieke Peters-Kop, Getty Huisman - de Waal, Alexandra van de Poll, Koen Hindriks, Mark Neerincx, Marcel Olde Rikkert. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 09.09.2020.)

Background and Purpose: Community-dwelling persons with dementia are inactive most of the day. The purpose of this study was to rank the barriers, motivators, and facilitators that hamper or promote physical activity (PA) participation for persons with dementia. This could provide knowledge that can be used to design effective interventions to promote PA participation for persons with dementia., Methods: Twenty community-dwelling persons with dementia, mean (SD) age = 79 (5.4) years, 25% female, mean (SD) Mini-Mental Status Examination score = 23 (3.5); their informal caregivers, N = 20, mean (SD) age = 70 (11.5) years, 85% female; and an expert group of physiotherapists, N = 15, mean (SD) age = 41 (12.4) years, 73% female, were asked to rank preselected barriers, motivators, and facilitators of PA participation for persons with dementia. These statements were categorized at the intrapersonal, interpersonal, and community levels., Results and Discussion: Persons with dementia and their informal caregivers selected only motivators and facilitators as being important for PA participation, with the motivator "beneficial health effects" considered the most important. The experts had a different perspective on PA participation; half of their ranked top 10 most important factors were barriers to PA participation for persons with dementia. This could be explained by the more critical role of a therapist, focusing on symptom control and treatment of disability; in this case, the elimination of barriers to maintain PA participation in their patients. Furthermore, all groups prioritized statements at the intrapersonal level., Conclusions: The results of this study suggest a difference in perspective between the more optimistic view of persons with dementia and their informal caregivers and the more critical view of physiotherapy experts regarding the most important factors that influence PA participation. In addition, there was a strong focus on the individual characteristics that influence PA behavior that warrant personalized interventions to promote PA in persons with dementia.

Background: The Older Persons and Informal Caregivers Minimum Data Set (TOPICS-MDS) is a standardized data set that was developed to evaluate the quality of multidimensional geriatric care. There is an inherent need to reduce the number of TOPICS-MDS survey items to core outcomes to allow it to be more easily applied as a patient-reported outcome measure in clinical settings., Objectives: To create a TOPICS-short form (TOPICS-SF) and examine its validity., Methods: Data in the TOPICS-MDS from persons aged 65 years and older in the Netherlands were used for the following analyses. Multiple linear regression analyses were performed to select the items and to derive domain weights of TOPICS-SF. A priori hypotheses were made on the basis of psychometric properties of the full-length TOPICS-MDS preference-weighted score (TOPICS-CEP). The validity of TOPICS-SF was evaluated by 1) examining the meta-correlation of the TOPICS-SF score with TOPICS-CEP and two quality-of-life measures, that is, the Cantril Ladder score and the EuroQol five-dimensional questionnaire utility index, and 2) performing mixed multiple regression of TOPICS-SF scores across key sociodemographic characteristics., Results: TOPICS-SF scores were strongly correlated with the TOPICS-CEP (r = 0.96) and had stronger correlation with the EuroQol five-dimensional questionnaire utility index compared with the Cantril Ladder (r = 0.61 and 0.38, respectively). TOPICS-SF scores were higher among older persons who were married, living independently, and having higher levels of education., Conclusions: We have developed the 22-item TOPICS-SF and demonstrated its validity, supporting its use as a patient-reported outcome measure in geriatric care., (Copyright © 2018 ISPOR --The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Introduction: Primary healthcare professionals will increasingly be required to manage and optimise their treatment for patients with dementia. With DementiaNet, we aim to reduce the burden of dementia on healthcare services and society through implementation and facilitation of integrated network-based care with increased dementia expertise. DementiaNet is designed as a stepwise approach including clinical leadership, quality improvement cycles and interprofessional training, which are tailor-made to the local context. For example, the composition of the network and improvement goals are tailored to the local context and availability. Here, we describe the linked evaluation study which aims to provide insight in effectiveness, process and mechanism of the DementiaNet approach through an innovative evaluation design., Methods and Analysis: We designed a longitudinal, mixed methods, multiple case study. Study population consists of two levels: (i) local DementiaNet networks of primary care professionals and (ii) patients and informal caregivers who receive care from these networks. At the start and after 12 and 24 months, quantitative data are collected for each network on: level of network maturity, quality of care indicators and outcomes reported by informal caregivers of dementia patients. We assess changes in networks over time and the association with quality of care and informal caregiver-reported outcomes. Throughout the study, logs about each network are registered. Additionally, semi-structured interviews with network members and informal caregivers will provide insight in experiences and opinions regarding effects and mechanisms through which changes in quantitative outcomes are effectuated. Rich narratives will be constructed about the development of the local networks using collected data., Ethics and Dissemination: The study protocol was reviewed by the local medical ethics committee; formal judgement was not required (protocol number: 2015-2053). The findings of this study will be disseminated through peer-reviewed publications, conference presentations and presentations for healthcare professionals where appropriate., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Informal care is essential for many people with dementia (PwD), but it often results in a considerable burden for the caregiver. The perseverance time instrument integrates the aspect of perceived burden with the caregiver's capacity to cope with the burden, in contrast to most available instruments, which measure solely the burden of caregiving. The aim of this study was to extend insight into psychometric properties of the perseverance time instrument, specifically the construct validity, responsiveness, and predictive validity, within the population of informal caregivers for PwD., Methods: Data from two studies among informal caregivers of community-dwelling PwD in the Netherlands were used. The first study included 198 caregivers from a single region in the Netherlands and lasted 1 year. The second was a cross-sectional nationwide study with 166 caregivers for PwD. Questionnaires of both studies included questions regarding demographics and informal care, perseverance time, and other informal caregiver outcomes (Caregiver Strain Index, Self-rated Burden scale, Care-related Quality of Life instrument, and visual analogue scale health scores). Construct validity and responsiveness were assessed using a hypothesis-testing approach. The predictive validity of demographic characteristics and perseverance time for living situation after 1 year (living at home, institutionalized, or deceased) was assessed with multivariable multinomial regression., Results: All but one of the hypotheses regarding construct validity were met. Three of five hypotheses regarding responsiveness were met. Perseverance time scores at baseline were associated with living situation after 1 year (p < 0.01), unlike age, sex, and relationship with PwD. Perseverance time strongly increased predictive power for living situation after 1 year (c-index between 0.671 and 0.775) in addition to demographic characteristics., Conclusions: This study supports previous findings regarding the construct validity of the perseverance time instrument and adds new evidence of good construct validity, responsiveness, and predictive validity. The predictive power of perseverance time scores for living situation exceeds the predictive power of other burden measures and indicates informal care as an important factor for maintaining the patient at home.

Background: Preference-weighted multi-faceted endpoints have the potential to facilitate comparative effectiveness research that incorporates patient preferences. The Older Persons and Informal Caregivers Survey-Composite endpoint (TOPICS-CEP) is potentially a valuable outcome measure for evaluating interventions in geriatric care as it combines multiple outcomes relevant to older persons in a single metric. The objective of this study was to validate TOPICS-CEP across different study settings (general population, primary care and hospital)., Methods: Data were extracted from TOPICS Minimum Dataset (MDS), a pooled public-access national database with information on older persons throughout the Netherlands. Data of 17,603 older persons were used. Meta-correlations were performed between TOPICS-CEP indexed scores, EuroQol5-D utility scores and Cantril's ladder life satisfaction scores. Mixed linear regression analyses were performed to compare TOPICS-CEP indexed scores between known groups, e.g. persons with versus without depression., Results: In the complete sample and when stratified by study setting TOPICS-CEP and Cantril's ladder were moderately correlated, whereas TOPICS-CEP and EQ-5D were highly correlated. Higher mean TOPICS-CEP scores were found in persons who were: married, lived independently and had an education at university level. Moreover, higher mean TOPICS-CEP scores were found in persons without dementia, depression, and dizziness with falls, respectively. Similar results were found when stratified by subgroup., Conclusion: This study supports that TOPICS-CEP is a robust measure which can potentially be used in broad settings to identify the effect of intervention or of prevention in elderly care.

Objectives: To assess the feasibility and validity of the International Dementia Alliance (IDEAL) instrument for Informal Caregivers (IDEAL-IC), which is based on the IDEAL instrument for professionals (IDEAL-P), for staging individuals with dementia., Design: Cross-sectional., Setting: Memory clinic of a university hospital., Participants: Informal caregivers of 73 community-dwelling elderly adults referred to a memory clinic and six geriatric registrars., Measurements: Caregivers completed the IDEAL-IC; physicians completed the original IDEAL-P and the Clinical Dementia Rating sum of boxes (CDR-SB). Missing items and floor and ceiling effects were reviewed to assess feasibility. To test construct validity, a priori hypotheses were defined for expected correlations between IDEAL-IC, IDEAL-P, and CDR-SB scores., Results: Seventy-three IDEAL-IC instruments were completed, 86% of which had no missing items. Three percent of all 730 individual items were missing. No floor or ceiling effects were detected. CDR scores were 0 7%, 0.5 in 33%, 1 in 27%, 2 in 10%, and unknown in 23%. IDEAL-IC scores correlated highly with IDEAL-P scores (correlation coefficient (r) = 0.70) and with CDR-SB scores (r = 0.65) as expected; the difference between these two correlations was smaller than expected. Agreement between IDEAL-IC and IDEAL-P scores was 34% within a range of 1 point difference on 36-point scales, 57% within a range of two points, and 81% within a range of five points. Correlation between IDEAL-P and CDR-SB was very high (r = 0.85)., Conclusion: Results of this study indicate good feasibility and high validity of staging dementia by informal caregivers using the IDEAL-IC., (© 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.)

Objective: To independently assess the inter-rater reliability of the International Dementia Alliance (IDEAL) schedule in Ireland and to examine criterion validity for cognitive functioning and caregiver distress., Methods: Two raters independently completed the IDEAL schedule based on an interview with persons diagnosed with dementia and their informal caregivers. The Clinical Dementia Rating (CDR) scale and the Zarit Burden Interview were used as reference standards for criterion validity. Intraclass coefficients (ICCs) and correlations (Spearman's ρ) were derived., Results: ICCs for the IDEAL subdomains ranged from 0.77 to 1.00, indicating robust agreement between raters. Strong correlations between the CDR and the IDEAL cognitive functioning domain (ρ = 0.82) and overall summary score (ρ = 0.77) were observed. The Zarit Burden Interview and the IDEAL carer distress subdomain were moderately correlated (ρ = 0.56)., Conclusion: This study confirmed that the IDEAL schedule is a valid and reliable instrument in the Irish population and further supports the international use of the IDEAL schedule., (Copyright © 2016 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.)

Objective: Evaluate the effectiveness of a training package to implement a community occupational therapy program for people with dementia and their caregiver (COTiD)., Design: Cluster randomized controlled trial., Subjects: A total of 45 service units including 94 occupational therapists, 48 managers, 80 physicians, treating 71 client-caregiver couples., Interventions: Control intervention: A postgraduate course for occupational therapists only., Experimental Intervention: A training package including the usual postgraduate course, additional training days, outreach visits, regional meetings, and access to a reporting system for occupational therapists. Physicians and managers received newsletters, had access to a website, and were approached by telephone., Primary Outcome: The intended adherence of therapists to the COTiD program. This was assessed using vignettes., Secondary Outcomes: clients' daily functioning, caregivers' sense of competence, quality of life, and self-perceived performance of daily activities of both clients and caregivers. Between-group differences were assessed using multilevel analyses with therapist and intervention factors as covariates., Results: No significant between-group differences between baseline and 12 months were found for adherence (1.58, 95% CI -0.10 to 3.25), nor for any client or caregiver outcome. A higher number of coaching sessions and higher self-perceived knowledge of dementia at baseline positively correlated with adherence scores. In contrast, experiencing more support from occupational therapy colleagues or having conducted more COTiD treatments at baseline negatively affected adherence scores., Conclusion: The training package was not effective in increasing therapist adherence and client-caregiver outcomes. This study suggests that coaching sessions and increasing therapist knowledge on dementia positively affect adherence., Clinical Trial Number: NCT01117285., (© The Author(s) 2014.)

Background: The Older Persons and Informal Caregivers Survey-Minimum Dataset (TOPICS-MDS) collects uniform information from research projects funded under the Dutch National Care for the Elderly Programme. To compare the effectiveness of these projects a preference-weighted outcome measure that combined multidimensional TOPICS-MDS outcomes into a composite endpoint (TOPICS-CEP) was developed based on the health state preferences of older persons and informal caregivers., Objectives: To derive preference weights for TOPICS-CEP's components based on health state preferences of healthcare professionals and to investigate whether these weights differ between disciplines and differ from those of older persons and informal caregivers., Materials and Methods: Vignette studies were conducted. Participants assessed the general wellbeing of older persons described in vignettes on a scale (0-10). Mixed linear analyses were used to obtain and compare the preference weights of the eight TOPICS-CEP components: morbidities, functional limitations, emotional wellbeing, pain experience, cognitive problems, social functioning, self-perceived health, and self-perceived quality of life (QOL)., Results: Overall, 330 healthcare professionals, 124 older persons and 76 informal caregivers participated. The preference weights were not significantly different between disciplines. However, the professionals' preference weights differed significantly from those of older persons and informal caregivers. Morbidities and functional limitations were given more weight by older persons and informal caregivers than by healthcare professionals [difference between preference weights: 0.12 and 0.07] while the opposite was true for pain experience, social functioning, and self-perceived QOL [difference between preference weights: 0.13, 0.15 and 0.26]., Conclusion: It is important to recognize the discrepancies between the health state preferences of various stakeholders to (1) correctly interpret results when studying the effectiveness of interventions in elderly care and (2) establish appropriate healthcare policies. Furthermore, we should strive to include older persons in our decision making process through a shared decision making approach.

Background: The Older Persons and Informal Caregivers Survey Minimal Dataset's (TOPICS-MDS) questionnaire which measures relevant outcomes for elderly people was successfully incorporated into over 60 research projects of the Dutch National Care for the Elderly Programme. A composite endpoint (CEP) for this instrument would be helpful to compare effectiveness of the various intervention projects. Therefore, our aim is to establish a CEP for the TOPICS-MDS questionnaire, based on the preferences of elderly persons and informal caregivers., Methods: A vignette study was conducted with 200 persons (124 elderly and 76 informal caregivers) as raters. The vignettes described eight TOPICS-MDS outcomes of older persons (morbidity, functional limitations, emotional well-being, pain experience, cognitive functioning, social functioning, self-perceived health and self-perceived quality of life) and the raters assessed the general well-being (GWB) of these vignette cases on a numeric rating scale (0-10). Mixed linear regression analyses were used to derive the preference weights of the TOPICS-MDS outcomes (dependent variable: GWB scores; fixed factors: the eight outcomes; unstandardized coefficients: preference weights)., Results: The mixed regression model that combined the eight outcomes showed that the weights varied from 0.01 for social functioning to 0.16 for self-perceived health. A model that included "informal caregiver" showed that the interactions between this variable and each of the eight outcomes were not significant (p > 0.05)., Conclusion: A preference-weighted CEP for TOPICS-MDS questionnaire was established based on the preferences of older persons and informal caregivers. With this CEP optimal comparing the effectiveness of interventions in older persons can be realized.

Introduction: In 2008, the Ministry of Health, Welfare and Sport commissioned the National Care for the Elderly Programme. While numerous research projects in older persons' health care were to be conducted under this national agenda, the Programme further advocated the development of The Older Persons and Informal Caregivers Survey Minimum DataSet (TOPICS-MDS) which would be integrated into all funded research protocols. In this context, we describe TOPICS data sharing initiative (www.topics-mds.eu)., Materials and Methods: A working group drafted TOPICS-MDS prototype, which was subsequently approved by a multidisciplinary panel. Using instruments validated for older populations, information was collected on demographics, morbidity, quality of life, functional limitations, mental health, social functioning and health service utilisation. For informal caregivers, information was collected on demographics, hours of informal care and quality of life (including subjective care-related burden)., Results: Between 2010 and 2013, a total of 41 research projects contributed data to TOPICS-MDS, resulting in preliminary data available for 32,310 older persons and 3,940 informal caregivers. The majority of studies sampled were from primary care settings and inclusion criteria differed across studies., Discussion: TOPICS-MDS is a public data repository which contains essential data to better understand health challenges experienced by older persons and informal caregivers. Such findings are relevant for countries where increasing health-related expenditure has necessitated the evaluation of contemporary health care delivery. Although open sharing of data can be difficult to achieve in practice, proactively addressing issues of data protection, conflicting data analysis requests and funding limitations during TOPICS-MDS developmental phase has fostered a data sharing culture. To date, TOPICS-MDS has been successfully incorporated into 41 research projects, thus supporting the feasibility of constructing a large (>30,000 observations), standardised dataset pooled from various study protocols with different sampling frameworks. This unique implementation strategy improves efficiency and facilitates individual-level data meta-analysis.

Background: In this paper, we aim to test the long-term benefit of an integrative reactivation and rehabilitation (IRR) program compared to usual care in terms of improved psychogeriatric patients on multiple psychiatric symptoms (MPS) and of caregivers on burden and competence. Improvement was defined as >30% improvement (≥ a half standard deviation) compared to baseline., Methods: We used the following outcome variables: difference in the number of improved patients on MPS (Neuropsychiatric Inventory, NPI) and improved caregivers on burden (Caregiver Burden, CB) and competence (Caregiver Competence List, CCL). Assessments were taken after intake (T1) and after six months of follow-up (T3). Risk ratios (RR), number needed to treat (NNT), and odds ratios (ORs) were calculated., Results: IRR had a significant positive effect on NPI-cluster hyperactivity (RR 2.64; 95% CI: 1.26-5.53; NNT 4.07). In the complete cases analysis, IRR showed significant ORs of 2.80 on the number of NPI symptoms and 3.46 on the NPI-sum-severity; up to 76% improved patients. For caregivers, competence was a significant beneficiary in IRR (RR 2.23; 95% CI: 1.07-4.62; NNT 5.07). In the complete cases analysis, the ORs were significantly in favor of IRR on general burden and competence (ORs range: 2.40-4.18), with up to 71% improved caregivers., Conclusion: IRR showed a significantly higher probability of improvement with a small NNT of four on multiple psychiatric symptoms in psychogeriatric patients. The same applies to the higher probability to improve general burden and competence of the caregiver with an NNT of five. The results were even more pronounced for those who fully completed the IRR program. (Inter)national psychogeriatric nursing home care and ambulant care programs have to incorporate integrative psychotherapeutic interventions.

Background: Patient involvement in clinical decision making is increasingly advocated. Although older patients may be more reluctant to become involved, most do appreciate being informed. However, knowledge about their experiences with and preferences for receiving information is limited, and even less is known about these topics for frail older people., Objective: To explore the experiences of frail older people and informal caregivers with receiving information from health care professionals as well as their preferences for receiving information., Methods: We conducted semi-structured interviews with frail older people (n = 11, 65-90 years) and informal caregivers (n = 11, 55-87 years). Interviews were transcribed verbatim and analysed using a grounded theory approach., Results: Frail older people and informal caregivers varied in their information needs and discussed both positive and negative experiences with receiving information. They preferred receiving verbal information from their physician during the consultation; yet would appreciate receiving brief, clearly written information leaflets in addition. They employed several strategies to enhance the information provided, i.e. advocacy, preparing for a consultation and searching their own information. Contextual factors for receiving information, such as having enough time and having a good relationship with professionals involved, were considered of great importance., Conclusions: Participants described a wide range of experiences with and preferences for receiving information. However, even if the information provided would meet all their preferences, this would be of limited significance if not provided within the context of an ongoing trusting relationship with a professional, such as a GP or practice nurse, who genuinely cared for them.

Background: A number of studies have examined the effects of home visits and showed inconsistent results on physical functioning, institutionalisation, and mortality. Despite continuing interest from professionals in home visits for older people, reports on older people's needs and preferences for such visits are scarce., Aim: This qualitative study aims to explore the views and needs of community-dwelling frail older people concerning home visits., Design and Setting: A qualitative study including interviews with frail older persons and their informal caregivers living in the area of Nijmegen, the Netherlands., Method: Semi-structured interviews were conducted with frail older people and informal caregivers. A grounded theory approach was used for data-analysis., Results: Eleven frail older people and 11 informal caregivers were included. Most participants emphasised the importance of home visits for frail older people. They felt that it would give older people the personal attention they used to receive from GPs but miss nowadays. Most stated that this would give them more trust in GPs. Participants stated that trust is one of the most important factors in a good patient-professional relationship. Further, participants preferred home visits to focus on the psychosocial context of the patient. They stated that more knowledge of the psychosocial context and a good patient-professional relationship would enable the professional to provide better and more patient-centred care., Conclusion: Patients' expectations of home visits are quite different from the actual purpose of home visiting programmes; that is, care and wellbeing versus cure and prevention. This difference may partly explain why the effectiveness of home visits remains controversial. Future studies on home visits should involve patients in the development of home visiting programmes.

Objective: Implementing evidence-based guidelines is not a simple task. This study aimed to define barriers to and facilitators for implementing the proven and effective Community Occupational Therapy in Dementia (COTiD) guideline for older people with dementia and their carers., Methods: The qualitative method we used was the grounded theory. We collected data from focus group interviews with 17 occupational therapists (OTs) and telephone interviews with 10 physicians and 4 managers. We analysed the data with the constant comparative method by identifying codes, categories, and main themes., Results: The main themes in barriers that OTs encountered were that they did not feel competent in treating older people with dementia at home according to the guideline; they had difficulties prioritising in this complex treatment, both for the client and themselves; and they were unsure about the minimal criteria for guideline adherence. The intensity of this programme was the main barrier. The barriers that confronted physicians and managers were lack of knowledge about occupational therapy and its reimbursement and lack of available trained OTs. For the OTs, the guideline's content and focus, evidence, and external support facilitated the use of the guideline. For physicians and managers, the guideline's evidence base and its benefits for clients and carers were the main facilitators., Conclusions: This study generates knowledge for applying innovations in health care settings. Improvement of the OTs' knowledge and self-confidence is needed for using the guideline. We expect that more competent OTs will motivate their physicians and managers to use this successful COTiD intervention., (Copyright © 2011 John Wiley & Sons, Ltd.)

Objective: To test the effectiveness of an integrative psychotherapeutic nursing home program (integrative reactivation and rehabilitation [IRR]) to reduce multiple neuropsychiatry symptoms (MNPS) of cognitively impaired patients and caregiver burden (CB)., Design: Randomized controlled trial., Setting: Psychiatric-skilled nursing home (IRR) and usual care (UC), consisting of different types of nursing home care at home or in an institution., Participants: N = 168 (81 IRR and 87 UC). Patients had to meet classification of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition for dementia, amnestic disorders, or other cognitive disorders. Further inclusion criteria: Neuropsychiatric Inventory (NPI) ≥3; Mini-Mental State Examination ≥18 and ≤27; and Barthel Index (BI) ≥5 and ≤19., Intervention: IRR consisted of a person-oriented integrative psychotherapeutic nursing home program to reduce MNPS of the patient and CB. UC consisted of different types of nursing home care at home or in an institution, mostly emotion oriented., Measurements: Primary outcome variable was MNPS (number and sum-severity of NPI). Furthermore, burden and competence of caregiver were also measured., Assessments: T1 (inclusion), T2 (end of treatment), T3 (after 6 months of follow-up). Cohen's d (Cd) was calculated for mean differences (intention to treat). For confounding, repeated measurement modeling (random regression modeling [RRM]) was applied., Results: In the short term from the perspective of the caregiver, IRR showed up to 34% surplus effects on MNPS of the patients; NPI symptoms: 1.31 lower (Cd, -0.53); and NPI sum- severity: 11.16 lower (Cd, -0.53). In follow-up, the effects were sustained. However, from the perspective of the nursing team, these effects were insignificant, although the trend was in the same direction and correlated significantly with the caregiver results over time (at T3: r = 0.48). In addition, IRR showed surplus effects (up to 36%) on burden and competence of caregiver: NPI emotional distress: 3.78 (Cd, -0.44); CB: 17.69 (Cd, -0.63) lower; and Competence: 6.26 (Cd, 0.61) higher. In follow-up, the effects increased up to 50%. RRM demonstrated that the effects were stable., Conclusion: From the perspective of the caregiver, IRR was significantly more effective than UC to reduce MNPS in cognitively impaired patients and CB. In follow-up, the effect on CB even increased. However, from the perspective of the nursing team, the effects on MNPS were statistically insignificant. Nevertheless, the trend was in the same direction and correlated significantly with the caregiver results over time. Further research is needed, preferably using a blinded randomized controlled trial.

Objectives: The primary aim of this study was to explore the impact of falling for frail community-dwelling older persons with and without cognitive impairments who have experienced a recent fall and their primary family caregivers. The secondary aim was to define components for a future fall prevention programme., Methods: Grounded theory interview study, with 10 patients (three cognitively unimpaired, four with mild cognitive impairment and three with dementia) and 10 caregivers., Results: All patients described a fear of falling and social withdrawal. Caregivers reported a fear of their care recipient (CR) falling. Most patients were unable to name a cause for the falls. Patients rejected the ideas that falling is preventable and that the fear of falling can be reduced. Some caregivers rated the consequences of their CRs' cognitive problems as more burdensome than their falls and believed that a prevention programme would not be useful because of the CRs' cognitive impairment, physical problems, age and personalities., Conclusion: Falling has major physical and emotional consequences for patients and caregivers. A fall prevention programme should focus on reducing the consequences of falling and on promoting self-efficacy and activity. The causes of falls should be discussed. The programme should include dyads of patients and caregivers because caregivers are highly involved and also suffer from anxiety. Before beginning such a programme, providers should transform negative expectations about the programme into positive ones. Finally, caregivers must learn how to deal with the consequences of their CRs' falling as well as their cognitive impairment.

Background: A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context., Methods/design: A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion., Discussion: The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment.The study is registered under DRKS00000053 at the German register of clinical trials, which is connected to the International Clinical Trials Registry Platform.

The objective of the study was to explore, in a sample of spouses of mild-to-moderate Alzheimer disease patients, predictors of quality of life (QoL) by rating QoL and burden. The authors assessed 97 spouses in a cross-sectional study with the Schedule for the Evaluation of Individual Quality of Life (SEIQoL), Self-Rated Burden scale (SRB), self-perceived stress scale (EDIZ; Ervaren Druk door Informele Zorg/Self-Perceived Pressure from Informal Care), and Zarit Burden Interview (ZBI). Patient cognition was rated with the Mini-Mental State Examination (MMSE). Factors best predicting QoL were analyzed with multiple regression analysis. Eighty-seven (53% male, mean 72 y) fulfilled the SEIQoL internal reliability criteria, and had a mean SEIQoL score of 68.6+/-14.8. Most important QoL domains were condition of patient (31%) and marriage (26%). Caregiver burden scores on SRB, Ervaren Druk door Informele, Zorg, and ZBI were 44.1+/-23.5 (n=67), 4.9+/-2.2 (n=53), and 13.1+/-6.2 (n=53), respectively. Mean patient MMSE score (0 to 30) was 20.3+/-4.2. Spouses experienced lower QoL than Alzheimer disease patients and healthy elderly (historical controls), and perceived moderate levels of burden. Patient cognition is a significant predictor of caregiver QoL. Burden, measured by ZBI, is significantly negatively correlated with SEIQoL. The results underline the importance of implementing health services known to improve QoL and alleviate burden, and to explore new effective interventions.

Objective: To evaluate the feasibility and present preliminary results of a cognitive behavioural group therapy for patients with mild cognitive impairment and their significant others., Design: One group pretest-posttest design., Subjects: Twenty-two patients with mild cognitive impairment and their significant others, running in four group programmes., Intervention: The main goal of the cognitive behavioural group therapy was to strengthen adaptive behaviour in 10 weekly 2-hour sessions., Main Measures: Distress and mood: The RAND-36, Geriatric Depression Scale--short form; Acceptance and helplessness: Subscales Acceptance and Helplessness from the Illness Cognition Questionnaire; Marital satisfaction: Maudsley Marital Questionnaire; Alertness to memory failure and behaviour changes: Informant Questionnaire on Cognitive Decline in the Elderly and the Revised Memory and Behaviour Problems Checklist Burden. The burden of caregiving reported by the significant others: Sense of competence Questionnaire and Behaviour Problems Checklist Burden, Hindrance subscale., Results: No changes were found on distress and mood measures in both patients and their significant others. Patients showed a significant increased level of acceptance (P<0.05) and a trend for an increased marital satisfaction (P<0.1). The significant others reported an increased awareness of memory and behavioural problems (P<0.05). Attendance was high, indicating a high motivation for this intervention., Conclusion: Preliminary results show evidence for positive changes after a cognitive behavioural group therapy for patients with mild cognitive impairment and their significant others. In addition, the developed programme is applicable and feasible. The programme's effectiveness should be studied further, with an estimated sample size of 70 couples in a controlled study design.

Rationale: Healthcare systems remain disease oriented despite growing sustainability concerns caused by inadequate management of patients with multimorbidity. Comprehensive care programmes (CCPs) can play an important role in streamlining care delivery, but large differences in setup and results hinder firm conclusions on their effectiveness. Many elements for successful implementation of CCPs are identified, but strategies to overcome barriers and embed programmes within health systems remain unknown. Aims and Objectives: To address this knowledge gap through a detailed study of implementing a CCP in a Dutch hospital setting, including patient experiences, facilitators, barriers and ways to overcome those barriers. Additionally, this study aims to explore effects on patient satisfaction and healthcare use. Methods: A qualitative study design with 39 semistructured interviews and focus groups between July 2020 and February 2023 with 16 patients and 17 involved professionals. Additionally, effects on quantitative outcomes for patient satisfaction (PACIC‐20) and healthcare use were explored. Results: Professionals expressed a wide range of topics related to implementation and ways to overcome barriers at hospital and system level. Alterations in the design to accommodate varying care demands, focus on inclusions through referrals, and lack of long‐term support and appropriate financing were key topics. Patients expressed varying experiences, stated a strong desire for comprehensive information, and emphasised the importance of trust in caregivers. Patient satisfaction showed no effects, while healthcare use showed slight decreases in trends, but patient numbers were limited. Conclusion: The introduction of a CCP is feasible, and exploratory analysis on effectiveness shows lower hospital care use without decreasing patient satisfaction. However, this is accompanied by several challenges that show current fragmented systems still do not support implementation of integrated care initiatives. Overcoming those comes with substantial costs and may require a strong bottom‐up implementation within a motivated team and actions on all levels of healthcare systems. [ABSTRACT FROM AUTHOR]

Background: Measurement of health-related quality of life (HRQoL) in dementia is difficult. At some point people with dementia become unable to meaningfully assess their own HRQoL. At such a point in time researchers need to rely on other types of information such as observation or assessments from informal caregivers (proxies). However, caregiver assessments may be biased by several mechanisms. The current study explores whether caregivers project part of their own HRQoL in their assessments of patient HRQoL. Methods: The participants in the current study were 175 pairs, consisting of community-dwelling persons with dementia and their caregivers. The EQ-5D, the EQ-VAS and the QoL-AD were administered to collect HRQoL measurements from patients and caregivers at baseline, 6 months and 12 months. Two linear mixed models were used to investigate factors that bias proxy ratings, one with the EQ-VAS as dependent variable, and one with the EQ-5D utility as dependent variable. The independent variables were caregiver age, caregiver sex and caregiver QoL-AD items. Results: The linear mixed model with EQ-VAS as dependent variable indicated that 3 caregiver characteristics, namely caregiver age, money (caregiver's financial situation) and valuation of life as a whole were significant predictors of the patient-by-proxy VAS scores. The linear mixed model with utility value as the dependent variable showed that caregiver age and valuation of the ability to do things for fun were significant predictors of the patient-by-proxy EQ-5D utility values. Conclusions: The current study was a first step in identifying factors that bias patient-by-proxy HRQoL assessments. It was discovered that caregivers project part of their own HRQoL onto patients when assessing patient HRQoL. This implies that patient-by-proxy HRQoL values should be interpreted with caution and not be used as a direct substitute for patient self-assessment, even when patients are no longer able meaningfully assess themselves. [ABSTRACT FROM AUTHOR]

Background: Index measures for health-related quality of life (HRQoL) quantify the desirability (utility) of a certain health state. The commonly used generic index measure, e.g. EuroQol: EQ-5D, may underestimate relevant areas of specific diseases, resulting in lower validity. Disease-specific index measures on the other hand combine disease-specificity and quantification of perceived quality on several health domains of a certain disease into one single figure. These instruments have been developed for several diseases, but a dementia-specific HRQoL index instrument was not yet available. Facing the increasing individual and societal burden of dementia, specific HRQoL values with metric characteristics are especially useful because they will provide vital information for health outcome research and economic evaluations. Aims of the study: To develop and validate the prototype of a dementia-specific HRQoL index measure: Dementia Quality of life Instrument (DQI), as the first step towards valuation of the dementia health state. Methods: For development of the DQI we created a conceptual framework based on a review of the literature, qualitative interviews with people with dementia and their carers, expert opinion and team discussion. To assess validity we undertook a survey under 241 dementia professionals. Measurements consisted of ranking (1-5) and rating (1-10) of 5 dementia-specific DQI domains (memory, orientation, independence, social activities and mood) and simultaneously rating of 9 DQI-derived health states on a visual analogue scale (VAS). We also performed a cross-sectional study in a large sample of people with very mild to moderate dementia and their caregivers (N = 145) to assess feasibility and concurrent validity. In addition, caregivers valued 10 DQI and 10 EQ-5D + C derived health states of the patient simultaneously on the same VAS. Setting: outpatient clinics, nursing homes and patient residences. Results: All professionals judged the selected DQI domains to be relevant. Differences in ranking and rating behaviors were small. Mood was ranked (≥3.3) and rated (≥8.2) as most, orientation as least important (rank ≤2.6, value 7.5) health domain for dementia. For the validation part of this study the completion rates for all domains were above 98% for patients and 100% for caregivers on patients. A priori hypothesized DQI versus QOL-AD correlations that were significant in both patients and caregivers were: memory/memory, orientation/memory, independence/physical health, social activities/energy and mood/mood. Patient/caregiver inter-rater agreement was low (K < 0.2) for memory/independence, fair (K 0.2-0.4) for orientation/mood, and moderate (K 0.4-0.6) for social activities. Concurrent validity of the DQI with the EQ-5D + C was moderate. The fact that most of the correlations between the domains of these two instruments were low (≤0.40) showed that both instruments measure different elements of health status. As expected, modest correlations (≥0.40) were observed between corresponding domains of the two instruments. Conclusions: Professionals judged all domains as relevant. The DQI prototype proved valid and feasible for patients and caregivers and is appropriate for very mild to moderate dementia. The differences in concurrent correlations with generic health status instruments imply that the dementia-specific DQI health domains indeed provide different information. The finding that patient HRQoL measured with the DQI was lower supports this notion. The new DQI shows comparable psychometric properties to the best available dementia-specific (QOL-AD) and generic (EQ-5D + C) measures. Further research is needed to generate values in the general population for each of the possible DQI states and to derive an algorithm that converts the 5 separate DQI domain scores into one single DQI Index score. Introducing the DQI Index will advance dementia-related HRQoL measurement by overcoming the shortcomings of generic and non-index instruments. This will allow more unequivocal interpretation of subjective dementia HRQoL states in dementia research. [ABSTRACT FROM AUTHOR]

Background: Due to fragmentation of care, continuity of care is often limited in the care provided to frail older people. Further, frail older people are not always enabled to become involved in their own care. Therefore, we developed the Health and Welfare Information Portal (ZWIP), a shared Electronic Health Record combined with a communication tool for community-dwelling frail older people and primary care professionals. This article describes the process evaluation of its implementation, and aims to establish (1) the outcomes of the implementation process, (2) which implementation strategies and barriers and facilitators contributed to these outcomes, and (3) how its future implementation could be improved. Methods: Mixed methods study, consisting of (1) a survey among professionals (n = 118) and monitoring the use of the ZWIP by frail older people and professionals, followed by (2) semi-structured interviews with purposively selected professionals (n = 12). Results: 290 frail older people and 169 professionals participated in the ZWIP. At the end of the implementation period, 55% of frail older people and informal caregivers, and 84% of professionals had logged on to their ZWIP at least once. For professionals, the exposure to the implementation strategies was generally as planned, they considered the interprofessional educational program and the helpdesk very important strategies. However, frail older people's exposure to the implementation strategies was less than intended. Facilitators for the ZWIP were the perceived need to enhance interprofessional collaboration and the ZWIP application being user-friendly. Barriers included the low computer-literacy of frail older people, a preference for personal communication and limited use of the ZWIP by other professionals and frail older people. Interviewees recommended using the ZWIP for other target populations as well and adding further strategies that may help frail older people to feel more comfortable with computers and the ZWIP. Conclusions: This study describes the implementation process of an innovative e-health intervention for community-dwelling frail older people, informal caregivers and primary care professionals. As e-health is an important medium for overcoming fragmentation of healthcare and facilitating patient involvement, but its adoption in everyday practice remains a challenge, the positive results of this implementation are promising. [ABSTRACT FROM AUTHOR]

Objectives: To make an inventory of needs assessment instruments in dementia, to explore the interaction between unmet needs and health-related quality of life (HRQoL) and to relate these to the conceptual model of Maslow's Hierarchy of needs in order to design a dementia-specific model. Methods: Narrative review of literature on (measures of) needs of patients and caregivers and HRQoL determinants important in dementia. Relating these needs to individual goal setting instruments and Maslow's Hierarchy of needs model. Results: The Camberwell Assessment of Needs for the Elderly (CANE) turns out to be a valid tool to assess needs of dementia patients, suitable for research and clinical use. The Carers' Needs Assessment for Dementia (CNA-D) is a valid instrument to assess needs of caregivers. Patients identified significantly fewer needs than (in)formal caregivers. The most important needs, that also determine large part of HRQoL, are need for information; support with regard to symptoms of dementia; social contact and company; and for health monitoring and safety. Goal attainment scaling in dementia is an important but not yet valid outcome measure, with only few data on feasibility in dementia patients. Conclusion: There are several instruments to assess needs of dementia patients and caregivers. Domains of unmet needs and HRQoL overlap. The Hierarchy Model of Needs in Dementia (HMND) offers a new theoretical framework to address the interplay between meeting of needs and improvement of HRQoL in dementia. By identifying unmet needs in dementia-research and focussing on unmet needs in dementia-care, much can be done to improve HRQoL. [ABSTRACT FROM AUTHOR]

Background: Current health care systems are not optimally designed to meet the needs of our aging populations. First, the fragmentation of care often results in discontinuity of care that can undermine the quality of care provided. Second, patient involvement in care decisions is not sufficiently facilitated. Objective: To describe the development and the content of a program aimed at: (1) facilitating self-management and shared decision making by frail older people and informal caregivers, and (2) reducing fragmentation of care by improving collaboration among professionals involved in the care of frail older people through a combined multidisciplinary electronic health record (EHR) and personal health record (PHR). Methods: We used intervention mapping to systematically develop our program in six consecutive steps. Throughout this development, the target populations (ie, professionals, frail older people, and informal caregivers) were involved extensively through their participation in semi-structured interviews and working groups. Results: We developed the Health and Welfare Information Portal (ZWIP), a personal, Internet-based conference table for multidisciplinary communication and information exchange for frail older people, their informal caregivers, and professionals. Further, we selected and developed methods for implementation of the program, which included an interdisciplinary educational course for professionals involved in the care of frail older people, and planned the evaluation of the program. Conclusions: This paper describes the successful development and the content of the ZWIP as well as the strategies developed for its implementation. Throughout the development, representatives of future users were involved extensively. Future studies will establish the effects of the ZWIP on self-management and shared decision making by frail older people as well as on collaboration among the professionals involved. [ABSTRACT FROM AUTHOR]

BACKGROUND: The objective of this study was to evaluate implementation of an innovative intervention designed to prevent complications and stimulate early rehabilitation among frail elderly inpatients. METHODS: The program was implemented in April 2011. A mixed-methods process evaluation and before-after study were performed. Primary effect outcomes included incidence of hospital-acquired delirium, cognitive decline, and decline in activities of daily living (ADL) during hospital stay. Secondary endpoints included ADL performance 3 months postdischarge, readmission, and caregiver burden RESULTS: One hundred ninety-one preintervention and 195 postintervention patients aged 70 years or older were included. Overall, no significant differences in primary endpoints were found. Mean ADL between discharge and follow-up improved (3.2 vs 5.7, P = .058). Caregivers rated burden of care lower at 3 months postdischarge (.5 vs -- .6, P = .049 RESULTS: One hundred ninety-one preintervention and 195 postintervention patients aged 70 years or older were included. Overall, no significant differences in primary endpoints were found. Mean ADL between discharge and follow-up improved (3.2 vs 5.7, P = .058). Caregivers rated burden of care lower at 3 months postdischarge (.5 vs -- .6, P = .049 CONCLUSIONS: The CareWell in Hospital program was implemented satisfactorily. Although the low baseline delirium incidence (11%), higher comorbidity, and an increasing learning curve during a restricted implementation period potentially influenced the overall effects, this integrated care program may have beneficial effects on outcomes among frail elderly surgical patients. [ABSTRACT FROM AUTHOR]

Objective: To assess whether a multifactorial fall prevention program was more effective than usual geriatric care in preventing falls and reducing fear of falling in frail community-dwelling older fallers, with and without cognitive impairment, and in alleviating subjective caregiver burden in caregivers. Design, Setting, and Participants: A randomized, 2 parallel-group, single-blind, multicenter trial conducted in 36 pairs of frail fallers, who were referred to a geriatric outpatient clinic after at least 1 fall in the past 6 months, and their informal caregivers. Intervention: Groups of 5 pairs of patients and caregivers received 10 twice-weekly, 2-hour sessions with physical and psychological components and a booster session. Measurements: The primary outcome was the fall rate during a 6-month follow-up. Additionally, we measured fear of falling and subjective caregiver burden. Data on the secondary outcome measures were collected at baseline, directly after, and at 3 and 6 months after the last session of the intervention. Results: Directly after the intervention and at the long-term evaluation, the rate of falls in the intervention group was higher than in the control group, although these differences were not statistically significant (RR = 7.97, P = .07 and RR = 2.12, P = .25, respectively). Fear of falling was higher in the intervention group, and subjective caregiver burden did not differ between groups. Conclusion: Although we meticulously developed this pairwise multifactorial fall prevention program, it was not effective in reducing the fall rate or fear of falling and was not feasible for caregivers, as compared with regular geriatric care. Future research initiatives should be aimed at how to implement the evidence-based principles of geriatric fall prevention for all frail fallers rather than developing more complex interventions for the frailest. [Copyright &y& Elsevier]

Complex interventions are difficult to develop, document, evaluate, and reproduce. Process evaluations aid the interpretation of outcome results by documenting and evaluating each process step in detail. Despite its importance, process evaluations are not embedded in all evaluations of complex interventions. Based on literature, we structured the process evaluation for trials on complex interventions into 3 main components: (1) the success rate of recruitment and quality of the study population, (2) the quality of execution of the complex intervention, and (3) the process of acquisition of the evaluation data. To clarify these process evaluation components and measures, we exemplified them with the preplanned process evaluation of a complex falls-prevention program for community-dwelling frail older fallers and their informal caregivers. The 3 process evaluation components are operationalized, results are presented, and implications discussed. This process evaluation identified several limitations of the intervention and effect study, and resulted in multiple recommendations for improvement of both the intervention as well as the trial. Thus, a good-quality process evaluation gives a detailed description of the most important components of a complex intervention, resulting in an in-depth insight in the actually performed intervention and effect analysis. This allows us to draw the appropriate conclusions on positive or negative trial results, and results in recommendations for implementation, or adjustment of the intervention or effect evaluation, respectively. [Copyright &y& Elsevier]