Positive aspects of caregiving among family carers of persons living with dementia not only benefit the carers' health, but also enhance the quality and sustainability of invaluable informal care resources. To better inform the development of carer support intervention to optimise positive aspects of caregiving, this paper tested the integrative theoretical model based on stress coping and meaning-making paradigms.
Longitudinal exploratory study.
From January 2018 to August 2021, 390 Chinese family carers of persons living with dementia were recruited from the geriatric clinics in Hong Kong. The criterion variable was measured by the Positive Aspect of Caregiving Scale at baseline and 6 months thereafter. The predictors were measured using the Dementia Management Strategies Scale, the Caregiving Self-Efficacy Scale, the Meaning-Focused Coping Scale, the Medical Outcome Study Social Support Survey, the Duke University Religion Index, the Positive Affect Index and the Intrinsic Motivations to Care. Path analysis tested the hypothesised model.
The carers aged 56.2 (SD = 12.2); about two-thirds being female and adult-child caregivers. The hypothesised model showed an unsatisfactory model fit. The model was optimised by modification index with consideration of the theoretical plausibility in making the changes (CFI = 0.971, RMSEA = 0.057, SRMR = 0.027). After adjusting the baseline PAC, the 6-month PAC was predicted by self-efficacy in controlling upsetting thoughts and obtaining respite as well as meaning-focused coping. Various contextual factors strengthened the self-efficacy and meaning-focused coping, indirectly increasing PAC. Whereas carers' intrinsic motivation towards care and good dyadic relationships increased the carer's self-efficacy in emotional regulation, social support and religiosity played indispensable roles to facilitate meaning-focused coping.
PAC in dementia context is evolved from an integration of stress coping and existential meaning-making paradigms. Enhancing emotion and role regulation as well as meaning-focused coping are crucial to enhance the positive experience of the family carers.
This project has generated a theory-driven and evidence-based predictive model to explain the manifestation of positive aspects of caregiving in dementia caregiving. The findings provide precise directions on how to empower family caregivers to create a fulfilling and meaningful caregiving adventure.
Substantial evidence indicates the role of positive aspects of caregiving in enhancing the carers' health outcomes in the context of dementia. However, inadequate theorization of this phenomenon delimits the momentum to develop proactive strategies to optimise such a positive caregiving experience. This longitudinal study indicated that positive aspects of caregiving are evolved from an integrative stress coping and existential meaning-making paradigm. More specifically, a sense of self-efficacy in emotional and role regulation as well as the use of meaning-making coping predict a higher level of positive aspects of caregiving. A context, which is characterised by high religiosity, good intrinsic motivation of care and a good dyadic relationship, also favours the cultivation of this positive experience during life adversity. This study facilitates a paradigm shift in supporting family carers in a dementia context and advances the theorization of positive human experience in facing life adversity.
The reporting method complies with the STROBE, stands for observational study.
Family carers of persons with dementia actively shared their experience in family caregiving.
Paternal incarceration represents a significant stressor that disrupts family cohesion, undermines paternal identity and adversely affects children’s psychosocial well-being. While family-focused programmes show promise in improving outcomes for incarcerated parents and their children, culturally attuned prison-based parenting interventions remain underdeveloped and scarce, particularly in Asian contexts. To address this gap, a local parenting intervention grounded in the Double ABCX model of family resilience, the ‘Be My Hero’ programme, was designed for incarcerated fathers in Hong Kong, China.
A concurrent mixed-methods design will be used to evaluate the intervention. A convenience sample of 20–30 incarcerated fathers of children aged 3–11 will be recruited from three correctional facilities. Quantitative measures assessing paternal competence, father–child attachment, communication and resilience will be collected preintervention and postintervention. Qualitative data will be triangulated through semistructured interviews with participants, their children and social workers, supplemented by session logs documenting perceived shifts in paternal identity and programme feasibility. The intervention is expected to mitigate disruptions in paternal identity and strengthen father–child bonds. This may, in turn, reduce intergenerational disadvantage and improve overall family well-being.
This study has received ethical approval from The University of Hong Kong. Informed consent and assent will be obtained from the participants, their children and current guardians. Findings will be disseminated through peer-reviewed journals or conferences to inform correctional rehabilitation practices, encouraging the integration of family-focused and resilience-based approaches. Stakeholders, including practitioners and policymakers, may adopt similar interventions to promote healthier re-entry outcomes and reduce intergenerational disadvantage.
Hypotension is a frequent complication after induction of general anaesthesia leading to end-organ injury, for which elderly and multimorbid patients are particularly susceptible. The extent of hypotension depends, among other factors, on the dose and rate of propofol administration. Target-controlled infusion systems are widely used to administer short-acting anaesthetics such as propofol and remifentanil. Commonly, induction is started with a fixed effect-site concentration. Titration, an alternative method of induction using an incremental augmentation of propofol, leads to a reduced induction dose and rate of propofol. We hypothesise that the titration method improves haemodynamic stability compared with conventional induction.
This multicentre, expertise-based randomised controlled trial takes place at four Swiss hospitals. Patients ≥55 years of age undergoing non-cardiac surgery under general anaesthesia using propofol target-controlled infusion are randomised to either a conventional or a titrated anaesthesia induction method. Patients, statisticians and, if resources allow, outcome assessors will be blinded. The primary endpoint is the mean arterial pressure under the individual baseline mean arterial pressure (area under threshold) during the first 30 min after start of induction. Secondary endpoints include the maximum deviation from baseline mean arterial pressure, haemodynamic rescue methods, propofol consumption and neurocognitive recovery after regaining consciousness.
A total of 320 patients are required to have an 80% chance of observing superiority of titration for the area under the threshold as significant at the 5% level, assuming a true difference of 100 mm Hg*min. The area under threshold and the maximum deviation will be compared between arms using mixed linear regression models.
Ethical approval has been obtained from all responsible ethics committees (BASEC2025-01007). The results will be presented at international meetings and published in peer-reviewed journals and may contribute to a change in clinical practice for anaesthesia induction using target-controlled infusion systems with propofol.
clinicaltrials.gov (NCT06980688) and www.humanforschung-schweiz.ch (HumRes67022).
To explore the conceptualisation of social frailty and discuss its role in shaping the disease trajectory of heart failure. Based on the discussion, recommendations on how to prevent and manage social frailty in this clinical cohort are delineated.
A discursive paper.
This paper searched two databases, PubMed and Google Scholar, for a narrative review of the literature related to social frailty and heart failure from 2008 to 2024.
By integrating the conceptualisation of social frailty from different theoretical paradigms, social frailty is a multi-domain construct that relies on a balance between the availability of environmental resources, social interactions and an individual's ability to maintain and acquire these resources to enhance their well-being. Substantial evidence showed the prognostic impact of social frailty on patient-reported, functional and clinical outcomes of patients with heart failure. The underlying mechanism is still under-investigated, but heart failure-related self-care may mediate its impact. Based on this evidence, improving social frailty may rely on a diagnostic protocol to enhance the person-centred care planning on ways to optimise the social resources to support complex self-care.
Social frailty poses a greater risk to health outcomes in patients with heart failure. Further research is needed to explore determinants and interventions for social frailty in this population.
This paper increases the awareness of social frailty in heart failure patients and provides important insights on how to combat this social determinant of poor health outcomes among this clinical cohort. A dual-purpose approach of improving social resources and self-care behaviours may have great promise in reducing their social frailty, and this postulation will need to be investigated in future research.
There is no involvement of patients or the public in the design or writing of this discursive paper.
This paper aims to describe the development of an inventory of chronic ambulatory care sensitive conditions (ACSCs) relevant to the Malaysian context and identify potentially preventable hospitalisations in the Malaysian Ministry of Health (MOH) facilities based on the developed list.
Consultative panel discussion, multi-panel modified Delphi and secondary health data analysis.
Setting: Malaysian MOH healthcare facilities.
42 experts from the family medicine and internal medicine specialties (modified Delphi), and 2022 inpatient data from MOH hospitals (secondary health data analysis).
A list of chronic ACSCs tailored to the Malaysian context and the proportion of potentially preventable hospitalisation in MOH hospitals.
10 conditions were identified as chronic ACSCs for Malaysia, namely angina, asthma, chronic kidney disease, convulsions and epilepsy, chronic obstructive pulmonary disease, diabetes mellitus, heart failure, hypertension, iron deficiency anaemia and ischaemic heart disease. In 2022, these conditions accounted for 8.6% of potentially preventable hospitalisations among the total hospitalisations in MOH hospitals.
This study provides a base list of chronic ACSCs tailored to the Malaysian context, which enables monitoring of potentially preventable hospitalisations due to chronic conditions. The findings underscore a proportion of hospital admissions that could potentially be avoided through interventions that enhance outpatient care. The conditions identified as ambulatory care sensitive provide specific targets for policy action and resource allocation to optimise outpatient health services and thus reduce the burden of hospitalisations in the country.
Malaysian National Medical Research Register, NMRR ID-23–02149-TBZ (https://nmrr.gov.my/research-directory/45c901d6-f121-4e79-9f38-dd7d283ec9a6).
The global population of older adults has grown at an unprecedented rate, and projections indicate that the number of older adults will continue to increase considerably in the coming decades. The clinical complexity of older adults living in retirement homes, also known as assisted living settings, is also increasing, and the regulations to ensure quality and safety standards in retirement homes are highly variable. The purpose of this scoping review is to map and summarise the methods used to monitor and measure the safety of older adults living in retirement homes, providing an overview of existing approaches and areas requiring further investigation.
This scoping review will follow the five stages of the Arksey and O’Malley scoping review process. We will report this review using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews. A comprehensive search of four electronic databases (MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) and Web of Science Core Collection) will be performed, and reference lists of included articles will be searched. We will conduct a two-step screening process, data extraction and analysis of the included studies. We will include all primary study designs that report on safety measurement and monitoring of any type of harms. Relevant grey literature will also be identified. We will exclude studies that only report results from facilities providing 24-hour skilled nursing care or specialised care services, and those not published in English or French. This protocol is registered on the Open Science Framework (osf.io/8rheq).
No ethical approval is needed for the review, and we plan to present the results at research conferences and in a peer-reviewed article. Our findings may inform future research studies that seek to support and improve safety practices in retirement homes.
To evaluate the association between asthma-related emergency department (ED) visits and weather, air quality, monsoons, haze and cultural festivals in Singapore.
Retrospective cohort study.
A public healthcare cluster that covers 20% of the nation’s adult asthma population.
2617 adult patients accounting for 5337 asthma ED visits between 2016 and 2024.
Temperature, rainfall, wet bulb temperature (WBT), wind speed and Pollution Standards Index (PSI) were correlated with asthma ED counts at 0–7 day lags. Associations between ED visits and monsoons, transboundary haze and cultural festivals were evaluated using one-way analysis of variance. Weekly seasonal ARIMA models with exogenous regressors were fitted, incorporating PSI as a covariate and adjusting for demographic, clinical and socioeconomic factors.
Asthma ED visits were positively correlated with PSI (lag 0: r=0.142; 95% CI 0.107 to 0.178) and inversely correlated with rainfall (lag 3: r=–0.062; 95% CI –0.099 to –0.026) and WBT (lag 1: r=–0.067; 95% CI –0.104 to –0.031). Wind speed (lag 2: r=–0.049; 95% CI –0.086 to –0.013) and ambient temperature (lag 6: r=–0.045; 95% CI –0.081 to –0.008) showed weaker inverse associations. Mean PSI was higher during haze (82.67 vs 51.46, p
PSI–ED association peaked on the same day of exposure but was no longer significant after adjusting for demographic and clinical factors. Pollution-linked festivals, transboundary haze and the Northeast monsoon were associated with increased asthma ED visits
Cardiovascular disease (CVD) risk remains high but unevenly distributed in patients with type 2 diabetes mellitus (T2DM). Current risk stratification strategies are far from optimal, leading to both undertreatment and overtreatment of patients. The STENO INTEN-CT trial aims to evaluate a strategy of improved CVD risk management by using cardiac CT (coronary artery calcification (CAC)) for stratification and tailoring of multifactorial cardiovascular treatment based on CAC score. We hypothesise that (1) intensified medical treatment will lower CVD event rates in high-risk patients (CAC≥100), and (2) less intensive multifactorial treatment is safe in very low-risk patients (CAC=0).
The Steno INTEN-CT trial is an investigator-initiated, pragmatic, open-label, event-driven randomised controlled trial including patients with T2DM without known CVD. All participants (expected n=7300) will be invited for a non-contrast coronary CT scan. After the scan, participants will be randomised to either standard treatment (blinded for CAC results) or CAC-based treatment. Participants in CAC-based treatment and their general practitioner (GP) will receive information on CAC and a recommendation of multifactorial treatment. High-risk participants in the interventional arm will be invited for one or more initial study visits to intensify treatment with a combination of sodium glucose co-transporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, high-dose lipid-lowering, antihypertensive and antithrombotic treatment. Very low-risk patients in the interventional arm will be recommended less intensive treatment targets. After initial study-related activities, all participants will continue to be taken care of by their GP guided by specific treatment recommendations. The primary outcome in the primary hierarchical analysis (the rate of the combined CVD endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for heart failure) will be monitored through national health registries. The trial is event-driven, but a median follow-up of 5 years is expected. Key secondary outcomes include patient-reported outcomes, quality-adjusted life years and healthcare costs.
The protocol V.1.9 is approved by the Research Ethics Committee and the Danish Medicines Agency and the Danish Data Protection Agency. The results of the study—positive, negative or neutral—will be published in peer-reviewed journals and through www.clinicaltrials.org.
The Veterans Health Administration (VA) integrated mental and physical health services to better detect and treat depression. Primary care nurses conduct screening annually. Clinicians, including Primary Care Mental Health Integration (PCMHI) specialists, follow-up as needed for treatment. Depression detection and management processes are complex, involve multilevel stakeholders, and are subject to significant disruption from COVID-19 and from the resulting expansion of telehealth, aiming to preserve care access. This study aimed to examine whether the COVID-19 pandemic worsened depression-related care quality and/or patient outcomes (eg, suicide).
Given hypothesised care disruption (lowered care quality) during COVID-19, we will first assess the VA population’s trajectory from a new positive depression (and suicide risk) screen to appropriate treatment (ie, medication, therapy) in the Fiscal Year 2019–2323. We will also examine the changing mix of virtual and in-person depression care delivered. Second, we will use interrupted time series analyses to explore the extent to which psychiatric emergency visits and hospitalisations may be mitigated by clinician detection of depression. As well as compare mental health-related mortality rates between patients detected and not detected to have depression. Subanalyses will reveal where (eg, clinics with low PCMHI access) and for whom (eg, minorities) detection does not systematically occur, and downstream negative sequelae, to guide future intervention. Finally, we will interview 40 veterans, half of whom were detected and half not detected to have depression and 40 VA primary care and PCMHI providers about changes brought on by the pandemic and the expansion of virtual care across three VA facilities. In addition to contextualising disrupted care findings, qualitative data will help identify best practices on patient-to-provider and provider-to-provider interactions in hybrid in-person/telehealth depression care models.
Ethics approval was granted by the VA Greater Los Angeles Healthcare System Institutional Review Board. Alongside journal publications, dissemination activities include briefings to our policy and operational partners, and presentations to clinical, research and policy-oriented audiences.
Internalised racism (IR) is broadly defined as the acceptance of negative racial stereotypes, beliefs and attitudes about one’s own racial or ethnic group. IR is increasingly recognised as a critical component and consequence of racial stress and trauma. Although IR has been linked to a variety of adverse mental and physical health outcomes, the phenomenon remains under-represented in intervention research. This scoping review addresses this gap by systematically mapping the range of interventions and intervention components that explicitly target IR among racially or ethnically minoritised communities and their health-related outcomes. This protocol paper will describe the process of the scoping review.
This review will follow methodology from the Joanna Briggs Institute and report using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. Using identified controlled vocabulary and keywords, searches will be undertaken using the following databases: MEDLINE, PsycInfo, Embase and Web of Science. This review will include studies describing any intervention or intervention component designed to reduce IR that is conducted with racially or ethnically minoritised populations in any context or setting. No date limit will be applied, and the study must be available in English. Conceptual or opinion pieces without a clear intervention framework will be excluded. Two reviewers will independently screen and select sources and extract data on intervention characteristics, theoretical underpinnings, outcomes and implementation details. Descriptive statistics will summarise study characteristics and outcomes, while a narrative synthesis will explore how interventions conceptualise and address IR. The findings will map existing approaches, highlight research gaps and inform future clinical practice and intervention development.
As this review uses published and publicly available data, no ethical approval is required. The findings will be disseminated through a peer-reviewed publication, conference presentations and briefs to stakeholder networks.
This protocol is registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/4VDBX).
Older age is one of the greatest risk factors of dementia, and the rural demographic is ageing in Canada. Compared with their urban counterparts, rural older adults often face unique challenges in accessing cognitive healthcare, which is exacerbated by a shortage of healthcare specialists, public transportation, finances, education, services and dispersed geography. This scoping review protocol outlines the methodology that will be used to examine the literature about the care priorities, service needs and lived experiences from the perspectives of rural older adults living with cognitive impairment and dementia in Canada.
Our scoping review protocol will follow the guidance of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extensions for Scoping Reviews checklist. Our search strategy will identify relevant peer-reviewed literature in databases including Cumulated Index in Nursing and Allied Health Literature (CINAHL), EMBASE, PsycINFO, PubMed, Web of Science and Scopus. The database search dates for this scoping review will be from 1 January 2015 to 1 January 2025. The data will be charted by two reviewers using a standardised data extraction table. Inductive content analysis will be performed using a three-step process.
Given this scoping review will be an examination of the published literature, human subjects will not be included in this research. Therefore, ethics approval is not required. Knowledge mobilisation and dissemination strategies will include peer-reviewed journal articles, conference presentations, community workshops, newsletter articles and webinars. This study may provide valuable information for healthcare practitioners, community leaders and policymakers working to support people living with cognitive impairment and dementia in rural communities.
To develop and pilot test the AdvantAGE transitional care model at a Swiss geriatric hospital.
Multi-method design.
The study progressed in three stages from January 2021 to December 2023: (1) contextual analysis using the Consolidated Framework for Implementation Research, incorporating qualitative interviews, (2) development and pilot testing of transitional care interventions on three acute geriatric wards using a descriptive explorative study design and (3) development and validation of a logic model using an iterative approach involving project interest groups and researchers.
We identified central challenges and needs related to transitions from hospital to home, including insufficient information flow, patient and caregiver insecurities and lacking adherence to recommended treatment. The newly developed transitional care model comprised five core elements: continuous support for patients and caregivers, care coordination with primary care providers, comprehensive health management at home, medication- and self-management with patients and caregivers and advance care planning. Of 137 eligible patients, 62 participated in the 10-month pilot test of the preliminary transitional care intervention, with an average participation duration of 69 days. Findings from the pilot informed the refinement of the intervention elements and the development of a preliminary logic model.
Employing an implementation science approach facilitated the development and refinement of the AdvantAGE model, ensuring alignment with the needs of project interest groups and the specific implementation context.
This study demonstrates the development of a transitional care model tailored to the specific needs and circumstances of the local healthcare context. Findings provide valuable insights for healthcare practitioners, researchers and policymakers, offering implications for developing transitional care practices and policies.
Limited patient and public involvement was incorporated, focusing on the interpretation of the findings of the first step of this study. Further contributions included providing feedback on the development of the elements of the AdvantAGE transitional care model, ensuring the research addressed priorities relevant to patients and primary health care providers in Basel-Stadt.
In deprived urban areas of South America, young people face heightened risks of mental disorders. Research suggests an association exists between social media engagement (SME), depression and anxiety.
This study explored the associations of SME with symptoms of depression, anxiety and subjective quality of life among young people from South American deprived urban areas.
Our cross-sectional survey study used an adapted version of the Multidimensional Facebook Intensity Scale to categorise 2399 participants into four SME groups: low, moderate, high and very high. Symptoms of depression (Patient Health Questionnaire-8), anxiety (Generalised Anxiety Disorder-7) and quality of life (Manchester Short Assessment) were assessed and compared using F and Tukey tests.
Each step of increased SME was associated with more symptoms of depression and anxiety and poorer quality of life. Statistically significant differences were observed across all groups (p
The findings suggest an association exists between SME, increased mental distress and lower quality of life in young people from deprived South American urban areas. This influence seems to apply across the spectrum of engagement levels, not only to extremes. However, due to the cross-sectional nature of the study, causal relationships cannot be established.
SME should be explored in clinical settings, as lower levels are associated with lower symptom levels and better quality of life. Policies addressing youth SME should be developed and evaluated in the challenging contexts of deprived urban areas.
Simulation is well established in medical education. However, with rising numbers of medical students globally, provision of high-quality, equitable simulation teaching on a large, multisite scale is increasingly challenging. We sought to explore whether a centrally designed, multisite simulation programme could enhance student confidence equitably across multiple clinical sites with differing resources.
An evaluative study on the changes in medical student confidence on defined intended learning outcomes (ILOs) in 3 undergraduate year groups across 11 simulation sessions delivered at eight different clinical sites with variable resources and facilitators.
Eight hospitals affiliated with Imperial College School of Medicine.
Students’ self-reported confidence in achieving the ILOs via a questionnaire at the end of each session. Changes in confidence following each session were analysed and compared across sites.
522 students responded to the survey over 3 academic years. Students’ mean confidence in achieving ILOs increased in all sessions. Nine out of 10 sessions showed no statistically significant difference in the confidence increases between sites.
Our study suggests it is possible to deliver an equitable, centrally designed, large-scale simulation teaching programme to medical students across multiple clinical sites with different facilitator teams. The programme is sustainable, easily facilitated by new teaching fellows each year and is likely adaptable to other healthcare professions and settings.
Childhood cancer accounts for a significant proportion of global childhood mortality, especially in low-income and middle-income countries (LMICs). Unlike many adult malignancies, primary prevention of childhood cancers is not possible. Improving survival requires a two-pronged strategy: earlier diagnosis and effective treatment. Our study aims to establish the feasibility, clinical and implementation effectiveness of an adapted early warning signs and symptoms (EWSS) intervention in Cameroon and Kenya. It will equip healthcare workers, Ministry of Health (MOH) representatives and National Cancer Institute leaders with evidence-informed guidance on implementing context-adapted interventions to improve the early detection and referral of childhood cancers in these countries.
The study is a quasi-experimental, hybrid type 2 implementation effectiveness study based on a Ghanaian adaptation of the ‘Saint Siluan’ EWSS campaign. Our protocol proposes context-specific adaptation and evidence-based implementation of the EWSS intervention through iterative engagement with country-level implementation teams to train healthcare workers and improve referral pathways for earlier childhood cancer diagnoses in each study country. Training effectiveness will be measured through pretraining and post-training tests of knowledge and application, as well as training satisfaction surveys. Clinical effectiveness will be assessed by using a REDCap database to track the number of newly diagnosed childhood cancer cases in the study regions and counties, healthcare timelines and paths to diagnosis, and the stage and proportion of metastatic disease at diagnosis. Implementation effectiveness will be evaluated through interviews with senior and mid-level health system partners and clinicians, tracking fidelity to the implementation process as laid out in The Implementation Roadmap Workbook, and analysis of meeting minutes from monthly local implementation team meetings.
This study has received ethical approval from The Hospital for Sick Children (REB # 1000080092) and all participating sites. We have received National Ethical Clearance from the Cameroon Ethical Board (#1699) and Regional Administrative Authorizations from our piloting regions (Centre and West). We have also received ethical clearance from Kenyatta National Hospital (KNH) (ERB# KNH-ERC/RR/955) and our National Commission for Science, Technology and Innovation in Kenya licence from the counties we are piloting in Kenya. As clinical data will be collected from existing health registries and patient charts, patient consent will not be required; however, we will obtain consent from all members of the leadership implementation teams and operational implementation teams for their participation in the implementation meetings and from all individuals participating in the semistructured interviews. We will disseminate findings to build awareness and share findings among various target audiences: (1) key county and regional parties (eg, clinical societies, advocacy groups, country MOHs and regional bodies such as the East African Community, Economic Community of West African States); (2) international bodies such as the WHO; and (3) the academic community.
While group, task-oriented, community-based exercise programs (CBEPs) delivered in-person can increase exercise and social participation in people with mobility limitations, challenges with transportation, cost and human resources, threaten sustainability. A virtual delivery model may help overcome challenges with accessing and delivering in-person CBEPs. The study objective is to estimate the short-term effect of an 8-week, virtual, group, task-oriented CBEP called TIME™ (Together in Movement and Exercise) at Home compared with a waitlist control on improving everyday function in community-dwelling adults with mobility limitations.
A randomised controlled trial incorporating a type 1 effectiveness-implementation hybrid design is being conducted in four Canadian metropolitan centres. We aim to stratify 200 adults with self-reported mobility limitations by site, participation alone or with a partner, and functional mobility level, and randomise them using REDCap software to either TIME™ at Home or a waitlist control group. During TIME™ at Home classes (2 classes/week, 1.5 hours/class), two trained facilitators stream a 1-hour exercise video and facilitate social interaction prevideo and postvideo using Zoom. A registered healthcare professional at each site completes three e-visits to monitor and support implementation. Masked evaluators with physical therapy training evaluate participants and their caregivers at 0, 2 and 5 months using Zoom. The primary outcome is the change in everyday function from 0 to 2 months, measured using the physical scale of the Subjective Index of Physical and Social Outcome. The study is powered to detect an effect size of 0.4, given α=0.05, power=80% and a 15% attrition rate. Secondary outcomes are mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, caregiver confidence in care-recipient balance and cost-effectiveness. A multimethod process evaluation is proposed to increase understanding of implementation fidelity, mechanisms of effect and contextual factors influencing the complex intervention. Qualitative data collection immediately postintervention involves interviewing approximately 16 participants and 4 caregivers from the experimental group, and 8 participants and 4 caregivers from the waitlist control group, and all healthcare professionals, and conducting focus groups with all facilitators to explore experiences during the intervention period. A directed content analysis will be undertaken to help explain the quantitative results.
TIME™ at Home has received ethics approval at all sites. Participants provide verbal informed consent. A data safety monitoring board is monitoring adverse events. We will disseminate findings through lay summaries, conference presentations, reports and journal articles.