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

BMC Geriatrics

Robyn Connors¹  Angela Riveroll²  Andrea Gruneir³  Marie-Eve Poitras⁴  Johanne Blais⁵  Janet MacIntyre⁶  Jean-Sébastien Paquette⁷  William Montelpare⁸  Jenny Ploeg⁹  Tracey Chambers⁹  Ruta Valaitis⁹  Maureen Markle-Reid⁹  Kathryn Fisher⁹  Marie-Lee Yous⁹  Rebecca Ganann⁹  France Légaré^1,10 

[1] Department of Applied Human Sciences, Faculty of Science, University of Prince Edward Island, Room 111, Steel Building, 550 University Avenue, C1A 4P3, Charlottetown, Prince Edward Island, Canada;Department of Applied Human Sciences, Faculty of Science, University of Prince Edward Island, Room 115, Steel Building, 550 University Avenue, C1A 4P3, Charlottetown, Prince Edward Island, Canada;Department of Family Medicine Research Program, University of Alberta, 6-40 University Terrace, T6G 2T4, Edmonton, Alberta, Canada;Department of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke - Campus Saguenay, 305 Rue Saint Vallier, Chicoutimi, G7H 5H6, QC, Canada;Department of Family Medicine and Emergency Medicine, Faculty of Medicine, Université Laval, Pavillon Ferdinand-Vandry, 1050, avenue de la Médecine, Local 4617, G1V 0A6, Québec, Canada;Faculty of Nursing, Room 116, Health Sciences Building, University of Prince Edward Island, 550 University Avenue, C1A 4P3, Charlottetown, Prince Edward Island, Canada;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, Pavillon Ferdinand-Vandry, 1050, Avenue de la Médecine, Local 4617, G1V 0A6, Québec, Canada;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, 550 University Avenue, C1A 4P3, Charlottetown, Prince Edward Island, Canada;School of Nursing, Aging, Community and Health Research Unit, Faculty of Health Sciences, McMaster University, 1280 Main Street West, Room HSc3N25, L8S 4K1, Hamilton, Ontario, Canada;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, G1K 7P4, Québec, Canada;

关键词: Older adults;    Patient-oriented intervention;    Diabetes;    Multiple chronic conditions;    Pragmatic effectiveness-implementation trial;    Self-management;    Community-based settings;    Scalability assessment;   

DOI  :  10.1186/s12877-021-02651-7

来源: Springer

【 摘 要 】

BackgroundOlder 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.MethodsWe 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.DiscussionAn 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 registrationClinical Trials.gov Identifier NCT03664583. Registration date: September 10, 2018.

【 授权许可】

CC BY