Clinical trial NCT03664583: ACHRU Community Partnership Program for Diabetes Self-Management for Older Adults - Canada
Official title: ACHRU Community Partnership Program for Diabetes Self-Management for Older Adults - Canada
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Chronic Conditions
Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2
Comorbidity
Aged
Health Services
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 295
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cross-jurisdictional, multi-site implementation-effectiveness type II hybrid randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The purpose of this study is to examine the implementation and effectiveness of the CPP intervention in new settings and populations to demonstrate widespread effectiveness and ways to adapt CPP for diverse population subgroups and primary care setting and community care contexts. Based on the investigator's previous work, we expect that the CPP intervention will result in a greater improvement in mental health and will be cost neutral relative to usual care because program costs will be offset by lower use of other health services. A cross-jurisdictional, multi-site implementation-effectiveness type II hybrid randomized controlled trial will be conducted. The trial will be conducted in two sites in each of Ontario, Quebec, and Prince Edward Island. Each of the six sites will involve a primary care setting and a community care organization. Study participants will be randomly assigned to the intervention or usual care group. Participants randomly assigned to the intervention group will be offered the 6-month CPP intervention in addition to their usual primary care services offered by their local diabetes education centre or primary care setting. The primary outcome of intervention effectiveness is patient mental health. Other health outcomes for patients and their caregivers will be assessed (e.g., depression, anxiety, use of health and social services etc.). Implementation will be examined in-detail through qualitative evaluations with providers, patients and caregivers. Engagement of patients and caregivers will occur in all stages of the research study. Qualitative evaluation of patients and caregivers as research partners will be conducted through annual evaluations. Patient, Public (e.g., caregivers, knowledge users) and Community (e.g., local providers/representatives) Research Partners will be engaged in the research study by way of the study's established governance structures: Community Advisory Boards, Patient Advisory Council, and Steering Committee. Qualitative evaluation of Patient, Public and Community Research Partners will be conducted to inform implementation of the CPP intervention at the local context and the potential for widespread implementation and scale-up. Both quantitative and qualitative evaluations will be used to interpret study findings, and in the development of scale-up plans.

Eligibility criteria: Inclusion Criteria:

Patient participants ("CPP Target Population") will be included in the study if they meet the following inclusion criteria:

* 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.

Caregiver participants will be included in the study if they meet the following inclusion criteria:

* 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

Provider and manager participants will be included in the study if they meet the following inclusion criteria:

* 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
* A manager of the PC at the community partner organization

Patient, Public and Community Research Partner participants will be included in the study if they meet the following inclusion criteria:

* Older adult living in the community, or
* Community living family or friend caregiver of a person with a diagnosis of diabetes and one or more chronic condition, or
* Community living health provider or manager of persons with diabetes and one or more chronic condition, or
* A knowledge user (e.g. policy maker) who works in health planning or health policy decision making at the community level representative of study sites
* Persons not receiving the CPP intervention

Exclusion Criteria:

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

Primary outcomes:
measure: Mental Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Mental Component Summary score.
timeFrame: Baseline, 6-months
Secondary outcomes:
measure: Self-Management Using the Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: Baseline, 6-months
measure: Physical Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Physical Component Summary score.
timeFrame: Baseline, 6-months
measure: Depressive Symptoms Using the Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10)
timeFrame: Baseline, 6-months
measure: Level of Anxiety Using the Generalized Anxiety Disorder 7-Item (GAD-7)
timeFrame: Baseline, 6-months
measure: Physical Activity Using the Physical Activity Scale for the Elderly (PASE)
timeFrame: Baseline, 6-months
measure: Caregiver Strain Using the Modified Caregiver Strain Index (MCSI)
timeFrame: Baseline, 6-months
measure: Social Support Using the Abbreviated Duke Social Support Index (DSSI)
timeFrame: Baseline, 6-months
measure: Functional Status Using the Duke Older Americans Resources and Services Procedures (OARS) Multidimensional Functional Assessment Questionnaire - Activities of Daily Living section
timeFrame: Baseline, 6-months
measure: Nutritional Status Using the Seniors in the Community Risk Evaluation for Eating and Nutrition tool (SCREEN II-AB)
timeFrame: Baseline, 6-months
measure: Shared Decision-Making Using the CollaboRATE tool
timeFrame: Baseline, 6-months
measure: Service Use Using the Health and Social Services Utilization Inventory (HSSUI)
timeFrame: Baseline, 6-months
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline, 6-months
measure: Glomerular Filtration Rate (GFR)
timeFrame: Baseline, 6-months
measure: Low-Density Lipoprotein (LDL)
timeFrame: Baseline, 6-months
measure: Collaboration Using the Partnership Self-Assessment Tool (PSAT)
timeFrame: 6-months
Other outcomes:
Locations:
city: Scarborough
country: Canada
facility: Scarborough Health Network
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Charlottetown
country: Canada
facility: University of Prince Edward Island
state: Prince Edward Island
city: Québec City
country: Canada
facility: L'Universite Laval
state: Quebec
Study officials:
affiliation: McMaster University
name: Maureen Markle-Reid, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.