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Introduction: Over 70% of the intensive care unit (ICU) survivors suffer from long-lasting physical, mental and cognitive problems after hospital discharge. Post-ICU care is recommended by international guidelines, but evidence for cost-effectiveness lacks. The aim of this study is to evaluate the clinical effectiveness and cost-effectiveness of structured, multidisciplinary and personalised post-ICU care versus usual care on physical and psychological functioning and health-related quality of life (HRQoL) of ICU survivors, 1- and 2-year post-ICU discharge., Methods and Analysis: The MONITOR-IC post-ICU care study (MiCare study) is a multicentre stepped-wedge randomised controlled trial conducted in five hospitals. Adult patients at high risk for critical illness-associated morbidity post-ICU will be selected and receive post-ICU care, including an invitation to the post-ICU clinic 3 months after ICU discharge. A personalised long-term recovery plan tailored to patients' reported outcome measures will be made. 770 (intervention) and 1480 (control) patients will be included. Outcomes are 1- and 2-year HRQoL (EuroQol Instrument (EQ-5D-5L)), physical (fatigue and new physical problems), mental (anxiety, depression and post-traumatic stress disorder), and cognitive symptoms and cost-effectiveness. Medical data will be retrieved from patient records and cost data from health insurance companies., Ethics and Dissemination: Due to the lack of evidence, Dutch healthcare insurers do not reimburse post-ICU care. Therefore, evaluation of cost-effectiveness and integration in guidelines supports the evidence. Participation of several societies for physicians, nurses, paramedics, and patients and relatives in the project team increases the support for implementation of the intervention in clinical practice. Patients and relatives will be informed by the patient associations, hospitals and professional associations. Informing healthcare insurers about this project's results is important for the consideration for inclusion of post-ICU care in Dutch standard health insurance. The study is approved by the Radboud University Medical Centre research ethics committee (2021-13125)., Trial Registration Number: NCT05066984., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To explore the course of quality of life (QoL) and possible resident-related predictors associated with this course in institutionalized people with young-onset dementia (YOD)., Design: An observational longitudinal study., Setting and Participants: A total of 278 residents with YOD were recruited from 13 YOD special care units in the Netherlands., Methods: Secondary analyses were conducted with longitudinal data from the Behavior and Evolution in Young-ONset Dementia (BEYOND)-II study. QoL was assessed with proxy ratings, using the Quality of Life in Dementia (QUALIDEM) questionnaire at 4 assessment points over 18 months. Predictors included age, gender, dementia subtype, length of stay, dementia severity, neuropsychiatric symptoms, and psychotropic drug use at baseline. Multilevel modeling was used to adjust for the correlation of measurements within residents and clustering of residents within nursing homes., Results: The total QUALIDEM score (range: 0-111) decreased over 18 months with a small change of 0.65 (95% confidence interval -1.27, -0.04) points per 6 months. An increase in several domains of QoL regarding care relationship, positive self-image, and feeling at home was seen over time, whereas a decline was observed in the subscales positive affect, social relations, and having something to do. Residents with higher levels of QoL and more advanced dementia at baseline showed a more progressive decline in QoL over time. Sensitivity analyses indicated a more progressive decline in QoL for residents who died during the follow-up., Conclusion and Implications: This study shows that although overall QoL in nursing home residents with YOD was relatively stable over 18 months, there were multidirectional changes in the QoL subscales that could be clinically relevant. Higher levels of QoL and more advanced stages of dementia at baseline predicted a more progressive decline in QoL over time. More longitudinal studies are needed to verify factors influencing QoL in YOD., (Copyright © 2020 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: Complementary interventions for persons with severe mental illness (SMI) focus on both personal recovery and illness self-management. This paper aimed to identify the patient-reported outcome measures (PROMs) associated with the most relevant and meaningful change in persons with SMI who attended the Illness Management and Recovery Programme (IMR)., Methods: The effect of the IMR was measured with PROMs concerning recovery, illness self-management, burden of symptoms and quality of life (QoL). From the QoL measures, an anchor was chosen based on the most statistically significant correlations with the PROMs. Then, we estimated the minimal important difference (MID) for all PROMs using an anchor-based method supported by distribution-based methods. The PROM with the highest outcome for effect score divided by MID (the effect/MID index) was considered to be a measure of the most relevant and meaningful change., Results: All PROMs showed significant pre-post-effects. The QoL measure 'General Health Perception (Rand-GHP)' was identified as the anchor. Based on the anchor method, the Mental Health Recovery Measure (MHRM) showed the highest effect/MID index, which was supported by the distribution-based methods. Because of the modifying gender covariate, we stratified the MID calculations. In most MIDs, the MHRM showed the highest effect/MID indexes., Conclusion: Taking into account the low sample size and the gender covariate, we conclude that the MHRM was capable of showing the most relevant and meaningful change as a result of the IMR in persons with SMI.

Background: Long-term community mental health treatment for non-psychotic disorder patients with severe mental illness (SMI) who are perceived as difficult by clinicians, is poorly developed and lacks a structured, goal-centred approach. This study compares (cost-)effectiveness of Interpersonal Community Psychiatric Treatment (ICPT) with Care As Usual (CAU) on quality of life and clinician perceived difficulty in the care for non-psychotic disorder SMI-patients. A multi-centre cluster-randomized clinical tria was conducted in which Community Mental Health Nurses (Clinicians) in three large community mental health services in the Netherlands were randomly allocated to providing either ICPT or CAU to included patients. A total of 56 clinicians were randomized, who treated a total of 93 patients (59 in ICPT-group and 34 in CAU-group)., Methods: Primary outcome measure is patient-perceived quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). Secondary outcome measures include clinician-perceived difficulty, general mental health, treatment outcomes, illness management and recovery, therapeutic relationship, care needs and social network. Patients were assessed at baseline, during treatment (6 months), after treatment (12 months) and at 6 months follow-up (18 months). Linear mixed-effects models for repeated measurements were used to compare mean changes in primary and secondary outcomes between intervention and control group of patients over time on an intention to treat basis. Potential efficiency was investigated from a societal perspective. Economic evaluation was based on general principles of a cost-effectiveness analysis. Outcome measures for health economic evaluation, were costs, and Quality Adjusted Life Years (QALYs)., Results: Half of the intended number of patients were recruited. There was no statistically significant treatment effect found in the MANSA (0.17, 95%-CI [- 0.058,0.431], p = 0.191). Treatment effects showed significant improvement in the Different Doctor-Patient Relationship Questionnaire-scores and a significant increase in the Illness Management and Recovery-scale Client-version scores). No effects of ICPT on societal and medical costs nor QALYs were found., Conclusions: This is the first RCT to investigate the (cost)-effectiveness of ICPT. Compared with CAU, ICPT did not improve quality of life, but significantly reduced clinician-perceived difficulty, and increased subjective illness management and recovery. No effects on costs or QALY's were found., Trial Registration: NTR 3988 , registered 13 May 2013.

Objective: Research into different patient populations suggests that, on average, proxies report poorer health-related quality of life (HRQoL) compared to self-reports. We aimed to investigate whether the difference between proxy reports and self-reports (interrater gap) varies across the whole range of self-reports from low to high HRQoL scores., Study Design and Setting: A cross-sectional study in 16 Dutch nursing home (NH) dementia special care (DSC) units (n = 256) and 17 somatic units (n = 326). Professional carers, blinded to self-reports, provided EuroQol-5D scores from two perspectives: their own perspective (proxy-proxy) of the patients' HRQoL and the estimation of the patient's view (proxy-patient)., Results: The interrater gap varied linearly in both DSC and somatic patients from proxy scores overestimating low self-reports to proxy scores underestimating high self-reports. This attenuation tendency existed for both proxy-proxy and proxy-patient perspectives. The interrater gap tended to be smaller for the proxy-patient perspective., Conclusions: Proxies (professional carers) tend to attenuate self-reports in NH patients with and without dementia toward moderate scores rather than report systematically poorer HRQoL. A proxy-patient perspective may be preferable to a proxy-proxy perspective for the purpose of estimating self-reports. Further research into other populations is needed to understand whether the attenuation tendency is a general phenomenon., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: The aim of this study was to compare conventional medical follow-up with follow-up containing additional nursing consultations regarding the psychosocial adjustment and health-related quality of life (HRQOL) of head and neck cancer patients., Methods: Using a quasi-experimental design, patients were enrolled consecutively into two groups. Experimental care covered six 30-min bimonthly nursing follow-up consultations during the first year posttreatment. Data were collected at posttreatment months 1 (baseline), 6, and 12 for both groups., Results: The intervention group was significantly worse at baseline, based on two of the seven adjustment scales and on the majority of HRQOL scales. However, their outcome at 6 and 12 months was consistent with that of the group which received conventional follow-up. Thus, the intervention group had a larger improvement in scores, and this was significant for one of the seven adjustment scales and 19 of the 33 HRQOL scales at 6 and 12 months, respectively. Most of the differences in HRQOL scales were clinically relevant at 6 months., Conclusion: These results suggest that nurse-led consultations for patients with head and neck cancer have a positive effect, primarily with respect to HRQOL. Nurse-led follow-up leads to a similar psychosocial adjustment as conventional follow-up, even among patients who showed worse performance at the start of follow-up. Thus, nurse-led follow-up may be a cost-effective way to improve follow-up care for this patient group.

Background: Metastatic colorectal cancer (CRC) is predominantly a disease of the elderly, therefore the current standards should be evaluated in this population., Material and Methods: We evaluated in different age groups the outcome in terms of median overall and progression-free survival, response rate, disease control rate, relative dose intensity (RDI), tolerability, and global quality of life (QoL) of first-line capecitabine monotherapy (CAP) versus capecitabine + irinotecan (CAPIRI) and capecitabine + oxaliplatin + bevacizumab (CAPOX + BEV) in the CAIRO and CAIRO2 study, respectively. Patients were categorized into three age groups: age > 75, 70-75 and < 70 years., Results: Clinical outcomes were not significantly different among age groups, with the exception of a higher response rate from CAP treatment in the elderly. Elderly patients treated with CAPOX + BEV showed a trend towards a worse median overall survival compared to younger patients. Only treatment with CAP resulted in a higher incidence of grade 3-4 toxicity and a lower RDI in elderly versus younger patients. Treatment with CAP and CAPOX + BEV in elderly patients was significantly more often discontinued due to toxicity instead of progression to disease compared to younger patients. The increase in global QoL was comparable for the three age groups for each treatment regimen., Conclusion: We did not observe significant differences in survival outcomes between elderly and younger metastatic CRC patients with three different first-line systemic treatment regimens. Our data suggest that initial dose reduction of CAP monotherapy may be indicated in elderly patients.

Background: People with intellectual disabilities are vulnerable to develop psychopathology (in particular anxiety) and related challenging behaviour. Method: A comparative multiple case study with an experimental and a control condition. Results: The application of the guideline showed a trend of decreases of internalizing problems (P = 0.07) and anxiety/depressed problems (P = 0.09). We found no statistically significant decreases of externalizing problems and no increases in perceived quality of life as compared with care as usual. Clients were not more satisfied with the support they received for coping with their emotional and behaviour problems. Conclusion: The application of the "Diagnostic Guideline for Anxiety and Challenging Behaviour" did not show statistically significant changes in externalizing problems and Quality of Life. Despite the small sample size of n = 59, we did find a trend in decreasing internalizing problems and anxiety/depressed problems. Further research into either or not confirming these trends is recommended.

Objective The purpose of this study was to assess whether the superior cost-effectiveness of a personalized physical therapy approach (Coach2Move)—which was demonstrated in a previous trial compared with usual care physical therapy (UCP)—can be replicated in daily clinical practice. Methods A multicenter, cluster-randomized, stepped wedge trial with 4 clusters consisting of 4 physical therapist practices in the Netherlands was used to compare a personalized physical therapy approach to elicit physical activity (Coach2Move) versus care as usual. Multilevel analyses for effectiveness were conducted for the amount of physical activity (Longitudinal Aging Study Amsterdam Physical Activity Questionnaire) and functional mobility (Timed "Up & Go" Test) at 3, 6 (primary outcome), and 12 months' follow-up. Secondary outcomes were level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient-Specific Complaints Questionnaires), quality of life (Euro Quality of Life-5 Dimensions-5 Levels [EQ-5D-5L]), and health care expenditures. Results The 292 community-dwelling older adults with mobility problems visiting physical therapists were included in either the Coach2Move (n = 112; mean [SD] age = 82 [5] years; 60% female) or UCP (n = 180; mean [SD] age = 81 (6) years; 62% female) section of the trial. At baseline, Coach2Move participants were less physically active compared with UCP participants (mean difference = −198; 95% CI = −90 to −306 active minutes). At 6 months, between-group mean differences [95% CI] favored Coach2Move participants on physical activity levels (297 [83 to 512] active minutes), functional mobility (−14.2 [−21 to −8]) seconds), and frailty levels (−5 [−8 to −1] points). At 12 months, the physical activity levels of Coach2Move participants further increased, and frailty levels and secondary outcomes remained stable, whereas outcomes of UCP participants decreased. After the Coach2Move implementation strategy, physical therapists utilized significantly fewer treatment sessions compared with before the implementation (15 vs 22). Anticipated cost savings were not observed. Conclusion This study replicated the results of an earlier trial and shows that Coach2Move leads to better mid- and long-term outcomes (physical activity, functional mobility, level of frailty) in fewer therapy sessions compared with UCP. Based on these and earlier findings, the implementation of Coach2Move in physical therapist practice is recommended. Impact This article describes the implementation of the Coach2Move approach, a treatment strategy that has proven to be cost-effective in a previously conducted randomized controlled trial. Implementation of Coach2Move in a real-life setting allowed an evaluation of the effects in a clinically relevant population. Coach2Move has been shown to increase physical activity, improve functional mobility, and reduce frailty more effectively compared with UCP therapy and therefore has application for physical therapists working with older adults in daily clinical practice. Lay summary Coach2Move is a new physical therapy approach for older adults. Implementation of Coach2Move in daily clinical practice can help people better outcomes over a longer period of time against similar costs compared with regular physical therapy. [ABSTRACT FROM AUTHOR]

Background Coach2Move is a personalized treatment strategy by physical therapists to elicit physical activity in community-dwelling older adults with mobility problems. Objective The primary objective of this study is to assess the effectiveness and cost-effectiveness of the implementation of Coach2Move compared with regular care physical therapy in daily clinical practice. Design, Setting, Participants, and Intervention A multicenter cluster-randomized stepped wedge trial is being implemented in 16 physical therapist practices (4 clusters of 4 practices in 4 steps) in the Netherlands. The study aims to include 400 older adults (≥70 years) living independently with mobility problems and/or physically inactive lifestyles. The intervention group receives physical therapy conforming to the Coach2Move strategy; the usual care group receives typical physical therapist care. Measurements Measurements are taken at baseline and 3, 6, and 12 months after the start of treatment. The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test). Trial success can be declared if at least 1 parameter improves while another does not deteriorate. Secondary outcomes are level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire), quality of life (EQ-5D-5 L), and health care expenditures. Multilevel linear regression analyses are used to compare the outcomes between treatment groups according to an intention-to-treat approach. Alongside the trial, a mixed-methods process evaluation is performed to understand the outcomes, evaluate therapist fidelity to the strategy, and detect barriers and facilitators in implementation. Limitations An important limitation of the study design is the inability to blind treating therapists to study allocation. Discussion The trial provides insight into the effectiveness and cost-effectiveness of the Coach2Move strategy compared with usual care. The process evaluation provides insight into influencing factors related to outcomes and implementation. [ABSTRACT FROM AUTHOR]

Background: A standard low-dosing schedule of rituximab (RTX; 2 × 500 mg or 1 × 1000 mg) is as effective for active rheumatoid arthritis (RA) as the registered dose (2 × 1000 mg). Moreover, several small uncontrolled studies suggest that even lower-dosed treatment with RTX also leads to good treatment response in patients with RA. Retreatment with such an 'ultra-low' dose RTX in patients who responded well to RTX induction treatment is of special interest, as long-term use of lower RTX doses may lead to shorter infusion duration, lower risk of adverse events and lower costs. However, the effect of ultra-low dose of RTX has not been investigated using a controlled trial of proper design and dimensions.Methods/design: REDO is an investigator driven six-month pragmatic, double-blind, randomised controlled non-inferiority trial on the effects of ultra-low-dose RTX (1 × 500 or 1 × 200 mg) compared to standard low dose (1 × 1000 mg) in RA patients who are being retreated with RTX. A total of 140 RA patients, having reached low disease activity (DAS28CRP < 2.9) after the previous RTX infusion and DAS28CRP < 3.5 at moment of retreatment, are randomised in a ratio of 1:2:2 to 1 × 1000 mg, 1 × 500 mg or 1 × 200 mg. The primary objective is testing non-inferiority of the ultra-low-dose vs. standard low-dose RTX, by comparing mean change in DAS28CRP from baseline to six months to the non-inferiority margin of 0.6. Secondary outcomes over the same period are: function; quality of life; safety; costs; and pharmacokinetics and dynamics as process measures.Discussion: This study protocol shares characteristics of both early dose finding trials as well as late pragmatic clinical studies. Several choices in the design of this trial are described and possible consequences for RA treatment and expected biosimilar introduction are discussed.Trial Registration: Dutch Trial Register, NTR6117 . Registered on 15 November 2016 (CMO NL57520.091.16 , 8 November 2016). [ABSTRACT FROM AUTHOR]

Background People with intellectual disabilities are vulnerable to develop psychopathology (in particular anxiety) and related challenging behaviour. A diagnostic guideline was developed to support professionals to better diagnose and thus treat psychopathology and related CB. This study examined preliminary outcomes from the application of this guideline. Method A comparative multiple case study with an experimental and a control condition. Results The application of the guideline showed a trend of decreases of internalizing problems ( P = 0.07) and anxiety/depressed problems ( P = 0.09). We found no statistically significant decreases of externalizing problems and no increases in perceived quality of life as compared with care as usual. Clients were not more satisfied with the support they received for coping with their emotional and behaviour problems. Conclusion The application of the Diagnostic Guideline for Anxiety and Challenging Behaviour did not show statistically significant changes in externalizing problems and Quality of Life. Despite the small sample size of n = 59, we did find a trend in decreasing internalizing problems and anxiety/depressed problems. Further research into either or not confirming these trends is recommended. [ABSTRACT FROM AUTHOR]

Background: Risk-reducing salpingo-oophorectomy (RRSO) around the age of 40 is currently recommended to BRCA1/2 mutation carriers. This procedure decreases the elevated ovarian cancer risk by 80-96% but it initiates premature menopause as well. The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL). Based on recent insights into the Fallopian tube as possible site of origin of serous ovarian carcinomas, an alternative preventive strategy has been put forward: early risk-reducing salpingectomy (RRS) and delayed oophorectomy (RRO). However, efficacy and safety of this alternative strategy have to be investigated. Methods: A multicentre non-randomised trial in 11 Dutch centres for hereditary cancer will be conducted. Eligible patients are premenopausal BRCA1/2 mutation carriers after completing childbearing without (a history of) ovarian carcinoma. Participants choose between standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) and the alternative strategy (RRS upon completion of childbearing and RRO at age 40-45 (BRCA1) or 45-50 (BRCA2)). Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age are included as well. Primary outcome measure is menopause-related QoL. Secondary outcome measures are ovarian/breast cancer incidence, surgery-related morbidity, histopathology, cardiovascular risk factors and diseases, and cost-effectiveness. Mixed model data analysis will be performed. Discussion: The exact role of the Fallopian tube in ovarian carcinogenesis is still unclear. It is not expected that further fundamental research will elucidate this role in the near future. Therefore, this clinical trial is essential to investigate RRS with delayed RRO as alternative risk-reducing strategy in order to improve QoL. [ABSTRACT FROM AUTHOR]

Background: People with young-onset dementia (YOD) living in nursing homes may experience poor quality of life (QoL) due to advanced dementia, high prevalence of neuropsychiatric symptoms and psychotropic drug use. However, the course of QoL in institutionalized people with YOD and factors that predict this course are unclear. This knowledge could help health professionals identify appropriate interventions to improve QoL in YOD. Objective: To explore the course of QoL in institutionalized people with YOD and resident-related predictors of that course. Methods: Secondary analyses were conducted with longitudinal data from the Behavior and Evolution in Young-ONset Dementia (BEYOND)-II study. A total of 278 people with YOD were recruited from 13 YOD special care units in the Netherlands. QoL was measured by the proxy assessment of Quality of Life in Dementia (QUALIDEM) questionnaire at four assessments over 18 months. Independent variables included age, gender, dementia subtype, length of stay, dementia severity, neuropsychiatric symptoms and psychotropic drug use at baseline. Multilevel modeling adjusted for correlation within nursing homes and residents was used to determine the course and predictors of QoL. Results: The total QUALIDEM score (range: 0–111) decreased over 18 months with a statistically significant decline of 0.73 points per six months. A significant increase of QoL over time was seen in the subscales "Care relationship", "Positive self-image", and "Feeling at home". However, a significant decline was observed in the subscales "Positive affect", "Social relations", and "Something to do". Residents' course of QoL was positively associated with the baseline scores of the QoL, age and longer duration of stay; however, being male, having advanced dementia, Alzheimer's disease and high rates of neuropsychiatric symptoms at baseline were negatively associated with the course of QoL Conclusion: Longitudinal changes in QoL in residents with YOD were small over 18 months and QUALIDEM subscales showed multidirectional changes. The largest QoL decline in the subscale "Positive affect" suggests that interventions should be targeted to improve positive emotions, in particular for male residents with neuropsychiatric symptoms and advanced dementia. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to compare conventional medical follow-up with follow-up containing additional nursing consultations regarding the psychosocial adjustment and health-related quality of life (HRQOL) of head and neck cancer patients. Methods: Using a quasi-experimental design, patients were enrolled consecutively into two groups. Experimental care covered six 30-min bimonthly nursing follow-up consultations during the first year posttreatment. Data were collected at posttreatment months 1 (baseline), 6, and 12 for both groups. Results: The intervention group was significantly worse at baseline, based on two of the seven adjustment scales and on the majority of HRQOL scales. However, their outcome at 6 and 12 months was consistent with that of the group which received conventional follow-up. Thus, the intervention group had a larger improvement in scores, and this was significant for one of the seven adjustment scales and 19 of the 33 HRQOL scales at 6 and 12 months, respectively. Most of the differences in HRQOL scales were clinically relevant at 6 months. Conclusion: These results suggest that nurse-led consultations for patients with head and neck cancer have a positive effect, primarily with respect to HRQOL. Nurse-led follow-up leads to a similar psychosocial adjustment as conventional follow-up, even among patients who showed worse performance at the start of follow-up. Thus, nurse-led follow-up may be a cost-effective way to improve follow-up care for this patient group. [ABSTRACT FROM AUTHOR]

Background: E-mental health holds promise for people with severe mental illness, but has a limited evidence base. This study explored the effect of e-health added to face-to-face delivery of the Illness Management and Recovery Programme (e-IMR).Method: In this multi-centre exploratory cluster randomized controlled trial, seven clusters (n = 60; 41 in intervention group and 19 in control group) were randomly assigned to e-IMR + IMR or IMR only. Outcomes of illness management, self-management, recovery, symptoms, quality of life, and general health were measured at baseline (T0), halfway (T1), and at twelve months (T2). The data were analysed using mixed model for repeated measurements in four models: in 1) we included fixed main effects for time trend and group, in 2) we controlled for confounding effects, in 3) we controlled for interaction effects, and in 4) we performed sub-group analyses within the intervention group.Results: Notwithstanding low activity on e-IMR, significant effects were present in model 1 analyses for self-management (p = .01) and recovery (p = .02) at T1, and for general health perception (p = .02) at T2, all in favour of the intervention group. In model 2, the confounding covariate gender explained the effects at T1 and T2, except for self-management. In model 3, the interacting covariate non-completer explained the effects for self-management (p = .03) at T1. In model 4, the sub-group analyses of e-IMR-users versus non-users showed no differences in effect.Conclusion: Because of confounding and interaction modifications, effectiveness of e-IMR cannot be concluded. Low use of e-health precludes definite conclusions on its potential efficacy. Low use of e-IMR calls for a thorough process evaluation of the intervention.Trial Registration: The Dutch Trial Register ( NTR4772 ). [ABSTRACT FROM AUTHOR]