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This pre-registration document describes the analysis plan for data from an online and telephone survey undertaken in Australia

Additional file 2. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Additional file 1. FORTRESS SPIRIT Checklist: Recommended items to address in a clinical trial protocol and related documents.

Additional file 2: Supplementary Material 1.

Additional file 1.

Additional file 1:. Figure A: Description and timing of the elements of the intervention. Figure B: Practical design considerations for a quality improvement collaborative in dementia care in Australia. Figure C: Example of completed reporting checklist (example used for the occupational therapy recommendation. Other versions used for exercise and carer support).

Additional file 1: Table S1. Additional usual care clinical services received by participants. Table S2. In reach rehabilitation provided after referral (nursing, speech pathology). Table S3. In-reach medical input from Geriatrician and Ortho-geriatric registrars. Table S4. In-reach physiotherapy received by participants. Table S5. In-reach dietetic intervention received by participants. Table S6. Adverse events for all participants according to group allocation. Table S7. Participants allocated to Intervention who died within 4 weeks of randomisation.

Objectives: This paper aimed to review and synthesise the qualitative research evidence on the experiences and perceptions of dementia in Vietnam and among the Vietnamese diaspora. Methods: Systematic searches were conducted in June 2019 using Medline, Embase, Emcare, PsycINFO and Cochrane electronic databases, as well as grey literature. Keywords and Medical Subject Headings [MeSH terms] for dementia and associated terms were combined with keywords for Vietnam and its provinces. Qualitative research articles published in English or Vietnamese were included to examine evidence on the life experiences of Vietnamese people with dementia using thematic analysis. Results: Our searches resulted in 3,940 papers, from which 21 qualitative research studies were included for final analysis. The majority of research has not been undertaken in Vietnam but with the Vietnamese diaspora in Western countries and has taken a cultural perspective to analyses. Research in Western countries has focused on the need for culturally adapted and culturally sensitive models of care. Emerging themes about the life experiences of Vietnamese people with dementia identified from the studies included: many people do not have diagnostic terms for dementia but use the descriptive language of symptoms; stigma was a reported problem and on occasions can be observed in the descriptive language used for people with dementia; cultural and traditional values create both an opportunity and a barrier, supporting compassion, family care and relaxation, but creating barriers to accessing health services or long-term residential care. Conclusions: This is the first systematic review reporting qualitative evidence on the life experiences of people with dementia in Vietnam and among the Vietnamese diaspora. Future research is needed on the voice of people with dementia themselves and their caregivers particularly in Vietnam, and low and middle-income countries with regards to living with dementia, pathways to care from diagnosis, treatment, care and support, additional social care and preparedness for end of life care for people with dementia. Refereed/Peer-reviewed

Background Frailty in older people is associated with increased risk of falls, longer length of stay in hospital, increased risk of institutionalisation and death. Frailty can be measured using validated tools. Multi-component frailty interventions are recommended in clinical practice guidelines but are not routinely implemented in clinical practice. Methods The Frailty in Older people: Rehabilitation, Treatment, Research Examining Separate Settings (FORTRESS) trial is a multisite, hybrid type II, stepped wedge, cluster, randomised trial with blinded assessment and intention-to-treat analysis being conducted in Australia. The study aims to determine the effectiveness and cost-effectiveness of an embedded individualised multicomponent frailty intervention (commencing in hospital and continuing in the community) on readmissions, frailty and quality of life when compared with usual care. Frail older people admitted to study wards with no significant cognitive impairment, who are expected to return home after discharge, will be eligible to participate. Participants will receive extra sessions of physiotherapy, pharmacy, and dietetics during their admission. A Community Implementation Facilitator will coordinate implementation of the frailty management strategies and primary network liaison. The primary outcome is number of days of non-elective hospital readmissions during 12 month follow-up period. Secondary outcomes include frailty status measured using the FRAIL scale; quality of life measured using the EQ-5D-5L; and time-to-event for readmission and readmission rates. The total cost of delivering the intervention will be assessed, and cost-effectiveness analyses will be conducted. Economic evaluation will include analyses for health outcomes measured in terms of the main clinical outcomes. Implementation outcomes will be collected as part of a process evaluation. Recruitment commenced in 2020 and we are aiming to recruit 732 participants over the three-year duration of the study. Discussion This study will reveal whether intervening with frail older people to address factors contributing to frailty can reduce hospital readmissions and improve frailty status and quality of life. If the FORTRESS intervention provides a clinically significant and cost-effective result, it will demonstrate an improved approach to treating frail patients, both in hospital and when they return home. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000760976p. ANZCTR registered 24 July 2020.

Objectives Health services worldwide are increasingly adopting consumer directed care approaches. Traditionally, consumer directed care models have been implemented in home care services and there is little guidance as to how to implement them in residential care. This study used a citizens’ jury to elicit views of members of the public regarding consumer directed care in residential care. Methods A citizens’ jury involving 12 members of the public was held over two days in July 2016, exploring the question: For people with dementia living in residential care facilities, how do we enable increased personal decision making to ensure that care is based on their needs and preferences? Jury members were recruited through a market research company and selected to be broadly representative of the general public. Results The jury believed that person-centred care should be the foundation of care for all older people. They recommended that each person’s funding be split between core services (to ensure basic health, nutrition and hygiene needs are met) and discretionary services. Systems needed to be put into place to enable the transition to consumer directed care including care coordinators to assist in eliciting resident preferences, supports for proxy decision makers, and accreditation processes and risk management strategies to ensure that residents with significant cognitive impairment are not taken advantage of by goods and service providers. Transparency should be increased (perhaps using technologies) so that both the resident and nominated family members can be sure that the person is receiving what they have paid for. Conclusions The views of the jury (as representatives of the public) were that people in residential care should have more say regarding the way in which their care is provided and that a model of consumer directed care should be introduced. Policy makers should consider implementation of consumer directed care models that are economically viable and are associated with high levels of satisfaction among users.

Objective: To empirically compare the measurement properties of the DEMQOL-U and DEMQOL-Proxy-U instruments to the EQ-5D-5L and its proxy version (CEQ-5D-5L) in a population of frail older people living in residential aged care in the post-hospitalisation period following a hip fracture. Methods: A battery of instruments to measure health-related quality of life (HRQoL), cognition, and clinical indicators of depression, pain and functioning were administered at baseline and repeated at 4 weeks’ follow-up. Descriptive summary statistics were produced and psychometric analyses were conducted to assess the levels of agreement, convergent validity and known group validity between clinical indicators and HRQoL measures. Results: There was a large divergence in mean (SD) utility scores at baseline for the EQ-5D-5L and DEMQOL-U [EQ-5D-5L mean 0.21 (0.19); DEMQOL-U mean 0.79 (0.14)]. At 4 weeks’ follow-up, there was a marked improvement in EQ-5D-5L scores whereas DEMQOL-U scores had deteriorated. [EQ-5D-5L mean 0.45 (0.38); DEMQOL-U mean 0.58 (0.38)]. The EQ-5D and CEQ-5D-5L were more responsive to the physical recovery trajectory experienced by frail older people following surgery to repair a fractured hip, whereas the DEMQOL-U and DEMQOL-Proxy-U appeared more responsive to the changes in delirium and dementia symptoms often experienced by frail older people in this period. Conclusions: This study presents important insights into the HRQoL of a relatively under-researched population of post-hospitalisation frail older people in residential care. Further research should investigate the implications for economic evaluation of self-complete versus proxy assessment of HRQoL and the choice of preference-based instrument for the measurement and valuation of HRQoL in older people exhibiting cognitive decline, dementia and other co-morbidities. Refereed/Peer-reviewed

Ageing is associated with weight loss and subsequently poor health outcomes. The present study assessed agreement between two field methods, bioelectrical impedance spectroscopy (BIS) and corrected arm muscle area (CAMA) for assessment of body composition against dual-energy X-ray absorptiometry (DXA), the reference technique. Agreement between two predictive equations estimating skeletal muscle mass (SMM) from BIS against SMM from DXA was also determined. Assessments occurred at baseline < 14 d post-surgery (n 79), and at 6 months (6M; n 75) and 12 months (12M; n 63) in community-living older adults after surgical treatment for hip fracture. The 95 % limits of agreement (LOA) between BIS and DXA, CAMA and DXA and the equations and DXA were assessed using Bland–Altman analyses. Mean bias and LOA for fat-free mass (FFM) between BIS and DXA were: baseline, 0·7 ( − 10·9, 12·4) kg; 6M, − 0·5 ( − 20·7, 19·8) kg; 12M, 0·1 ( − 8·7, 8·9) kg and for SMM between CAMA and DXA were: baseline, 0·3 ( − 11·7, 12·3) kg; 6M, 1·3 ( − 4·5, 7·1) kg; 12M, 0·9 ( − 5·4, 7·2) kg. Equivalent data for predictive equations against DXA were: equation 1: baseline, 15·1 ( − 9·5, 20·6) kg; 6M, 17·1 ( − 12·0, 22·2) kg; 12M, 17·5 ( − 13·0, 22·0) kg; equation 2: baseline, 12·6 ( − 7·3, 19·9) kg; 6M, 14·4 ( − 9·7, 19·1) kg; 12M, 14·8 ( − 10·7, 18·9) kg. Proportional bias (BIS: β = − 0·337, P< 0·001; CAMA: β = − 0·294, P< 0·001) was present at baseline but not at 6M or 12M. Clinicians should be cautious in using these field methods to predict FFM and SMM, particularly in the acute care setting. New predictive equations would be beneficial., This research was supported by the National Health and Medical Research Council (NHMRC), Australia.

Introduction Generic instruments for assessing health related quality of life may lack the sensitivity to detect changes in health specific to certain conditions, such as dementia. The Quality of Life in Alzheimer's Disease (QOL-AD) is a widely used and well-validated condition-specific instrument for assessing health-related quality of life for people living with dementia, but it does not enable the calculation of quality-adjusted life years, the basis of cost utility analysis. This study will generate a preference based scoring algorithm for a health state classification system-the Alzheimer's Disease Five Dimensions (AD-5D) derived from the QOL-AD.Methods and analysis Discrete choice experiments with duration (DCETT0,) and best worst scaling health state valuation tasks will be administered to a representative sample of 2000 members of the Australian general population via an online survey and to 250 dementia dyads (250 people with dementia and their carers) via face-to-face interview. A multinomial (conditional) logistic framework will be used to analyse responses and produce the utility algorithm for the AD-5D.Ethics and dissemination The algorithms developed will enable prospective and retrospective economic evaluation of any treatment or intervention targeting people with dementia where the QOL-AD has been administered and will be available online. Results will be disseminated through journals that publish health economics articles and through professional conferences. This study has ethical approval. Introduction Generic instruments for assessing health related quality of life may lack the sensitivity to detect changes in health specific to certain conditions, such as dementia. The Quality of Life in Alzheimer's Disease (QOL-AD) is a widely used and well-validated condition-specific instrument for assessing health-related quality of life for people living with dementia, but it does not enable the calculation of quality-adjusted life years, the basis of cost utility analysis. This study will generate a preference based scoring algorithm for a health state classification system-the Alzheimer's Disease Five Dimensions (AD-5D) derived from the QOL-AD. Methods and analysis Discrete choice experiments with duration (DCETTO) and best–worst scaling health state valuation tasks will be administered to a representative sample of 2000 members of the Australian general population via an online survey and to 250 dementia dyads (250 people with dementia and their carers) via face-to-face interview. A multinomial (conditional) logistic framework will be used to analyse responses and produce the utility algorithm for the AD-5D. Ethics and dissemination The algorithms developed will enable prospective and retrospective economic evaluation of any treatment or intervention targeting people with dementia where the QOL-AD has been administered and will be available online. Results will be disseminated through journals that publish health economics articles and through professional conferences. This study has ethical approval. Refereed/Peer-reviewed

Background: The rate of falls in community dwelling older people with cognitive impairment (CI) is twice that of a cognitively intact population, with almost two thirds of people with CI falling annually. Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people. However the potential benefit of these interventions in reducing falls in people with CI has not been established. This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI. We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers. A health economic analysis examining the cost and potential benefits of the program will also be undertaken. Methods and design: Three hundred and sixty people aged 65 years or older living in the community with CI will be recruited to participate in the trial. Each will have an identifiable carer with a minimum of 3.5 hours of face to face contact each week. Participants will undergo an assessment at baseline with retests at 6 and 12 months. Participants allocated to the intervention group will participate in an exercise and home hazard reduction program tailored to their cognitive and physical abilities. The primary outcome measure will be the rate of falls which will be measured using monthly falls calendars. Secondary outcome measures will include the risk of falling, quality of life, measures of physical and cognitive function, fear of falling and planned and unplanned use of health services. Carers will be followed up to determine carer burden, coping strategies and quality of life. Discussion: The study will determine the impact of this tailored intervention in reducing the rate of falls in community dwelling older people with CI as well as the cost-effectiveness and adherence to the program. The results will have direct implications for the design and implementation of interventions for this high-risk group of older people. Trial registration: The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12614000603617

Background Proximal femoral fractures are amongst the most devastating consequences of osteoporosis and injurious accidental falls with 25–35% of patients dying in the first year post-fracture. Effective rehabilitation strategies are evolving however, despite established associations between nutrition, mobility, strength and strength-related functional outcomes; there has been only one small study with older adults immediately following fragility fracture where a combination of both exercise and nutrition have been provided. The aim of the INTERACTIVE trial is to establish whether a six month, individualised exercise and nutrition program commencing within fourteen days of surgery for proximal femur fracture, results in clinically and statistically significant improvements in physical function, body composition and quality of life at an acceptable level of cost and resource use and without increasing the burden of caregivers. Methods and Design This randomised controlled trial will be performed across two sites, a 500 bed acute hospital in Adelaide, South Australia and a 250 bed acute hospital in Sydney, New South Wales. Four hundred and sixty community-dwelling older adults aged > 70 will be recruited after suffering a proximal femoral fracture and followed into the community over a 12-month period. Participants allocated to the intervention group will receive a six month individualised care plan combining resistance training and nutrition therapy commencing within 14 days post-surgery. Outcomes will be assessed by an individual masked to treatment allocation at six and 12 months. To determine differences between the groups at the primary end-point (six months), ANCOVA or logistic regression will be used with models adjusted according to potential confounders. Discussion The INTERACTIVE trial is among the first to combine nutrition and exercise therapy as an early intervention to address the serious consequence of rapid deconditioning and weight loss and subsequent ability to regain pre-morbid function in older patients post proximal femoral fracture. The results of this trial will guide the development of more effective rehabilitation programs, which may ultimately lead to reduced health care costs, and improvements in mobility, independence and quality of life for proximal femoral fracture sufferers. Trial registration Australian Clinical Trials Registry: ACTRN12607000017426.