ACHRU Community Partnership Program for Diabetes Self-Management for Older Adults - Canada

NCT03664583 | Unknown

• 1 other identifier: KPG 156883
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 4

Brief Summary

Living with diabetes and other chronic (ongoing) conditions is common in older adults. These individuals have poorer health and higher use of health services compared to older adults with diabetes alone. Programs that help older adults self-manage their diabetes and other health conditions benefit both individuals and the healthcare system. The McMaster University Aging, Community and Health Research Unit developed and tested a new patient-centered, community-based program (CPP) to improve the delivery and outcomes of care for older adults with diabetes and other chronic conditions. This 6-month program was developed in partnership with patients, caregivers, primary and community care providers and researchers. The program is delivered by nurses, dietitians and community providers. It involves in-home or virtual visits by nurses and dietitians, monthly group wellness sessions at community centers or virtually, and monthly virtual team meetings. Wellness sessions include exercise, education, and social support. Caregivers are invited to be active participants along with patients. The program was successfully implemented in Ontario and Alberta. Participants who received the program had better quality of life, self-management, and mental health at no additional cost from a societal perspective compared to those receiving usual care. To determine how the program can best help people, more testing is needed with different communities and groups of people. We will partner with primary healthcare teams (e.g., family doctors' offices) in three provinces to adapt and test the program in a variety of real-world settings. We will assess how to best put this program into practice and measure outcomes important to patients and caregivers so study results are relevant to them. Study findings will guide the development of a plan for expanding the program to reach and benefit more older adults with diabetes and other chronic health conditions. Patients and caregivers will be involved as key partners in all aspects of the research.

Conditions

Multiple Chronic Conditions; Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 2; Comorbidity; Aged; Health Services

Outcome Measures

Primary Outcomes (1)

• Mental Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Mental Component Summary score.

  The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess mental health. The tool consists of 12 questions that measure functional health and well-being from the participant's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, social functioning, role-emotional, mental health), by which a psychometrically-based Physical Component Summary (PCS) and Mental Component Summary (MCS) can be calculated. Response options include the frequency of feeling a certain way or behaviour across 3 or 5 categories (e.g., 'all of the time'...'none of the time'). Patients and caregivers will be evaluated for change in SF-12-MCS from baseline to 6-months. Total scale range: 0 - 100. Higher scores represent better mental functioning.

  Baseline, 6-months

Secondary Outcomes (15)

• Self-Management Using the Summary of Diabetes Self-Care Activities (SDSCA)

  Baseline, 6-months

• Physical Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Physical Component Summary score.

  Baseline, 6-months

• Depressive Symptoms Using the Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10)

  Baseline, 6-months

• Level of Anxiety Using the Generalized Anxiety Disorder 7-Item (GAD-7)

  Baseline, 6-months

• Physical Activity Using the Physical Activity Scale for the Elderly (PASE)

  Baseline, 6-months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients randomly assigned to the intervention group will be offered the ACHRU-Community Partnership Program (CPP) intervention in addition to usual primary care services offered by their local diabetes education centre or primary care setting. The CPP is a 6-month self-management intervention consisting of six core components: 1) home or virtual visits (up to 3) supported by phone calls by either a Registered Nurse (RN) or Registered Dietician (RD); 2) wellness sessions (up to 6, one per month) provided to patients and their caregivers at the location of the community partner or virtually; 3) monthly team case conferences with the provider team; 4) caregiver support; 5) collaboration with the primary care interprofessional team and other specialists; 6) nurse-led care coordination/system navigation.

Behavioral: ACHRU-Community Partnership Program (CPP)

Control Group

NO INTERVENTION

Those who are randomly assigned to the control group will continue to be offered usual primary care services through their local diabetes education centre or primary care setting. The services that comprise usual diabetes care vary across the provinces e.g., length and focus of educational sessions, whether classes are strongly recommended versus optional (e.g., foot care, cardiac health, eating and exercise interventions), home visits, access to on-site professionals (e.g., endocrinologist, dietitian, physiotherapist, exercise specialist, pharmacist), connections with support services and community resources, and type of follow-up services available. Details of usual care provided at each site will be recorded.

Interventions

ACHRU-Community Partnership Program (CPP) BEHAVIORAL

The intervention is a 6-month community navigation and self-management program for patients with diabetes and at least one additional chronic condition, and their caregivers, to improve health outcomes. The intervention will be provided by an interprofessional team of providers and consists of six core components.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosis of type 1 or type 2 diabetes
• Aged 65+ years
• Enrolled in a primary care organization
• Diagnosed with at least one other chronic condition
• Residing in the area served by the primary care and community site
• Capable of providing informed consent, or has a substitute decision-maker who is able to provide informed consent on his/her behalf
• Competent in English or has an interpreter who is competent in English for Ontario and Prince Edward Island (PEI) study sites. Patient participants that score 5 or higher on The Short Portable Mental Status Questionnaire (SPMSQ) will be eligible as patient participants. Those with scores below 5 will be eligible if they have a proxy decision-maker.
• Identified by the patient participant as an informal family or friend caregiver
• At least 18 years of age
• Provides physical, emotional, or financial care to the patient participant
• Scores 5 or higher on the SPMSQ
• Working with the primary care setting or community partner organization at a study site
• Either a Registered Nurse (RNs) or Registered Dietitian (RDs) at the primary care setting
• A Program Coordinator (PC) from the community partner organization
• A manager of the RN or RD at the primary care setting

You may not qualify if:

• Patient and caregiver participants in Ontario and PEI who do not speak English and do not have an interpreter/translator

Sponsors & Collaborators

• McMaster University: lead

Study Sites (4)

Scarborough Health Network

Scarborough Village, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

University of Prince Edward Island

Charlottetown, Prince Edward Island, Canada

Location

L'Universite Laval

Québec, Quebec, Canada

Location

Related Publications (4)

• Fisher K, Carusone SC, Ganann R, Markle-Reid M, Northwood M, Sherifali D. Transforming healthcare by prioritizing qualitative and quantitative clinical trial evidence: evaluating the Aging, Community and Health Research Unit's Community Partnership Program for Older Adults (ACHRU-CPP). Trials. 2025 May 13;26(1):154. doi: 10.1186/s13063-025-08839-1.

  PMID: 40361198 DERIVED

• Northwood M, Chambers T, Fisher K, Ganann R, Markle-Reid M, Yous ML, Beleno R, Gaudet G, Gruneir A, Leung H, Lindsay C, Luebke K, Macartney G, Macatangay E, MacIntyre J, MacPhail C, Montelpare W, Morrison A, Shaffer L, St Pierre M, Tang F, Whiteside C. Readiness for scale up following effectiveness-implementation trial: results of scalability assessment of the Community Partnership Program for diabetes self-management for older adults with multiple chronic conditions. BMC Health Serv Res. 2025 Feb 20;25(1):284. doi: 10.1186/s12913-025-12378-5.

  PMID: 39979911 DERIVED

• Yous ML, Ganann R, Ploeg J, Markle-Reid M, Northwood M, Fisher K, Valaitis R, Chambers T, Montelpare W, Legare F, Beleno R, Gaudet G, Giacometti L, Levely D, Lindsay C, Morrison A, Tang F; ACHRU-CPP Research Team. Older adults' experiences and perceived impacts of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) for diabetes self-management in Canada: a qualitative descriptive study. BMJ Open. 2023 Apr 5;13(4):e068694. doi: 10.1136/bmjopen-2022-068694.

  PMID: 37019487 DERIVED

• Ploeg J, Markle-Reid M, Valaitis R, Fisher K, Ganann R, Blais J, Chambers T, Connors R, Gruneir A, Legare F, MacIntyre J, Montelpare W, Paquette JS, Poitras ME, Riveroll A, Yous ML; ACHRU-CPP Research Team. 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 Geriatr. 2022 Feb 4;22(1):99. doi: 10.1186/s12877-021-02651-7.

  PMID: 35120457 DERIVED

MeSH Terms

Conditions

Multiple Chronic Conditions; Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Maureen Markle-Reid, RN, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A cross-jurisdictional, multi-site implementation-effectiveness type II hybrid randomized controlled trial

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 10, 2018
• Study Start: April 1, 2019
• Primary Completion: May 20, 2022
• Study Completion: March 31, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

CA (4)