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
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Published:2022-02-04
Issue:1
Volume:22
Page:
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ISSN:1471-2318
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Container-title:BMC Geriatrics
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language:en
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Short-container-title:BMC Geriatr
Author:
Ploeg JennyORCID, Markle-Reid Maureen, Valaitis Ruta, Fisher Kathryn, Ganann Rebecca, Blais Johanne, Chambers Tracey, Connors Robyn, Gruneir Andrea, Légaré France, MacIntyre Janet, Montelpare William, Paquette Jean-Sébastien, Poitras Marie-Eve, Riveroll Angela, Yous Marie-Lee, Ploeg Jenny, Markle-Reid Maureen, Valaitis Ruta, Fisher Kathryn, Ganann Rebecca, Blais Johanne, Gruneir Andrea, Légaré France, MacIntyre Janet, Montelpare William, Paquette Jean-Sébastien, Poitras Marie-Eve, Riveroll Angela, Charif Ali Ben, Eurich Dean, Gafni Amiram, Lewis Gary, Mansell Lynne, Pritchard Janet, Sherifali Diana, Thabane Lehana, Upshur Ross, Williamson Tyler, Northwood Melissa, Sadowski Cheryl, Tang Frank,
Abstract
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.
Funder
Canadian Institutes of Health Research Diabetes Action Canada McMaster Institute for Research on Aging McMaster University School of Nursing Réseau-1 Quebec Fonds de Recherche du Québec - Santé Scarborough Health Network Foundation Tier 2 CIHR Canada Research Chair in Person-Centred Interventions for Older Adults with Multimorbidity and their Caregivers
Publisher
Springer Science and Business Media LLC
Subject
Geriatrics and Gerontology
Reference104 articles.
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