BMC Geriatrics | |
The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP) for older adults with diabetes and multiple chronic conditions: study protocol for a randomized controlled trial | |
on behalf of the ACHRU-CPP Research Team1  Robyn Connors2  Angela Riveroll2  Andrea Gruneir3  Marie-Eve Poitras4  Johanne Blais5  Janet MacIntyre6  Jean-Sébastien Paquette7  William Montelpare8  Rebecca Ganann9  Marie-Lee Yous9  Ruta Valaitis9  Tracey Chambers9  Kathryn Fisher9  Maureen Markle-Reid9  Jenny Ploeg9  France Légaré1,10  | |
[1] ;Department of Applied Human Sciences, Faculty of Science, University of Prince Edward Island;Department of Family Medicine Research Program, University of Alberta;Department of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke - Campus Saguenay;Department of Family Medicine and Emergency Medicine, Faculty of Medicine, Université Laval, Pavillon Ferdinand-Vandry;Faculty of Nursing, Room 116, Health Sciences Building, University of Prince Edward Island;Groupe de Médecine de Famile Universitaire (GMF-U) du Nord de Lanaudière and Department of Family Medicine and Emergency Medicine, Faculty of Medicine Université Laval;Margaret and Wallace McCain Chair in Human Development and Health, Department of Applied Human Sciences, Faculty of Science, Room 122, Health Sciences Building, University of Prince Edward Island;School of Nursing, Aging, Community and Health Research Unit, Faculty of Health Sciences, McMaster University;VITAM-Centre de recherche en santé durable, Université Laval, Pavillon Landry-Poulin, 2525, Chemin de la Canardière, Quebec City, QC, G1J 0A4, Canada and Department of Family Medicine and Emergency Medicine, Faculty of Medicine, Université Laval; | |
关键词: Older adults; Patient-oriented intervention; Diabetes; Multiple chronic conditions; Pragmatic effectiveness-implementation trial; Self-management; | |
DOI : 10.1186/s12877-021-02651-7 | |
来源: DOAJ |
【 摘 要 】
Abstract Background Older adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality. Many community-based self-management interventions have been developed for this group, however the evidence for their effectiveness is limited. This paper presents the protocol for a randomized controlled trial (RCT) comparing the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) to usual care in older adults with diabetes and MCC and their caregivers. Methods We will conduct a cross-jurisdictional, multi-site implementation-effectiveness type II hybrid RCT. Eligibility criteria are: ≥65 years, diabetes diagnosis (Type 1 or 2) and at least one other chronic condition, and enrolled in a primary care or diabetes education program. Participants will be randomly assigned to the intervention (ACHRU-CPP) or control arm (1:1 ratio). The intervention arm consists of home/telephone visits, monthly group wellness sessions, multidisciplinary case conferences, and system navigation support. It will be delivered by registered nurses and registered dietitians/nutritionists from participating primary care or diabetes education programs and program coordinators from community-based organizations. The control arm consists of usual care provided by the primary care setting or diabetes education program. The primary outcome is the change from baseline to 6 months in mental functioning. Secondary outcomes will include, for example, the change from baseline to 6 months in physical functioning, diabetes self-management, depressive symptoms, and cost of use of healthcare services. Analysis of covariance (ANCOVA) models will be used to analyze all outcomes, with intention-to-treat analysis using multiple imputation to address missing data. Descriptive and qualitative data from older adults, caregivers and intervention teams will be used to examine intervention implementation, site-specific adaptations, and scalability potential. Discussion An interprofessional intervention supporting self-management may be effective in improving health outcomes and client/caregiver experience and reducing service use and costs in this complex population. This pragmatic trial includes a scalability assessment which considers a range of effectiveness and implementation criteria to inform the future scale-up of the ACHRU-CPP. Trial registration Clinical Trials.gov Identifier NCT03664583 . Registration date: September 10, 2018.
【 授权许可】
Unknown