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Multiple Chronic ConditionsACHRU-CPPNCT03664583

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

A study testing ACHRU-Community Partnership Program (CPP) in people with Multiple Chronic Conditions and Diabetes Mellitus, run by McMaster University at 4 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
ACHRU-Community Partnership Program (CPP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
295 participants
Where
4 sitesCanada
Study dates
1 Apr 2019to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 25Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Canada4 sites
  • University of Prince Edward Island

    Charlottetown, Prince Edward Island

  • L'Universite Laval

    Québec, Quebec

  • Scarborough Health Network

    Scarborough Village, Ontario

  • St. Michael's Hospital

    Toronto, Ontario

Other trials in Canada

About this study

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.

Read the 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.

Being tested
ACHRU-Community Partnership Program (CPP)
Keywords
Diabetes Mellitus, Type 2, Comorbidity, Aged, Health Services
Medical subject headings
Multiple Chronic Conditions, Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACHRU-Community Partnership Program (CPP)Behavioural

    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.

Study groups in NCT03664583
Study groupRoleWhat they receive
Intervention GroupExperimentalPatients 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.
Receives: Behavioral: ACHRU-Community Partnership Program (CPP)
Control GroupNo interventionThose 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 6-months

Secondary outcomes (15)
  1. Self-Management Using the Summary of Diabetes Self-Care Activities (SDSCA)

    The Summary of Diabetes Self-Care Activities (SDSCA) will be used to assess self-management. The SDSCA is a multidimensional measure of diabetes self-management with adequate internal and test-retest reliability, and evidence of validity and sensitivity to change. The revised SDSCA consists of 11 items that assess the following aspects of the diabetes regimen: (1) general and specific diet; (2) exercise; (3) blood-glucose testing; (4) foot care; and (5) smoking. Change in patient self-management will be evaluated using the SDSCA. Scale range: 0 - 71. Higher scores represent better self-management.

    Measured: Baseline, 6-months

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

    The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess physical 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) score 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-PCS from baseline to 6-months. Total scale range: 0 - 100. Higher scores represent better physical functioning.

    Measured: Baseline, 6-months

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

    The Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10) will be used to assess depressive symptoms. This tool has been used in prior studies of older adults with mood disorders, has a high degree of reliability and validity, and is a sensitive tool for measuring changes in depressive symptoms over time. Participants will be asked about the way they have felt or behaved in response to 10 statements such as 'I was happy'. Response options ask participants to select the frequency they have felt or behaved during the last week, ranging from 'rarely or none of the time (less than 1 day)', 'some or a little of the time (1-2 days)', 'occasionally or moderate (3-4 days)', to 'most or all of the time (5-7 days)'. Patients and caregivers will be evaluated for change in depressive symptoms using CES-D-10. Scale range: 0 - 30. Higher scores represent more depressive symptoms.

    Measured: Baseline, 6-months

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

    The Generalized Anxiety Disorder 7-Item (GAD-7) will be used to assess anxiety levels. The GAD-7 is a 7-item tool that asks about the type and frequency of being bothered by a list of problems. Response options include 'not at all', 'several days', 'more than half the days', or 'nearly every day', over the last two weeks. Patients and caregivers will be evaluated for change in level of anxiety using GAD-7. Scale range: 0 - 21. Higher scores represent more anxiety.

    Measured: Baseline, 6-months

  5. Physical Activity Using the Physical Activity Scale for the Elderly (PASE)

    The Physical Activity Scale for the Elderly (PASE) tool will be used to assess the physical activity of patients. The PASE measures physical activity over the past 7 days. It asks about the type and frequency of physical activity across categories of light, moderate and strenuous physical activity. Patients will be evaluated for change in physical activity using the PASE tool. Higher scores represent better physical activity.

    Measured: Baseline, 6-months

  6. Caregiver Strain Using the Modified Caregiver Strain Index (MCSI)

    The Modified Caregiver Strain Index (MCSI) will be used to assess caregiver strain. This tool will ask caregivers a list of 13 activities that they may have found to be difficult such as sleeping, physical strain, financial strain, personal plans, and work and family adjustments as a result of the caregiver role. Response options include 'yes' according to two levels, either 'yes, on a regular basis' or 'yes, sometimes', or alternatively, 'no'. Scale range: 0 - 26. Higher scores represent more strain.

    Measured: Baseline, 6-months

  7. Social Support Using the Abbreviated Duke Social Support Index (DSSI)

    The abbreviated, 11-item Duke Social Support Index (DSSI) will be used to measure social support. This 11-item instrument includes two major sub-scales: a 4-item social interaction sub-scale and a 7-item subjective support sub-scale. Response options on the social interaction sub-scale ask participants to rate the frequency of their social interactions in the past week: "none", "1-2", ">2", or "0-1 time", "2-5 times", "6 or more times". Response options on the subjective support sub-scale include "hardly ever", "some of the time", "most of the time", or "very dissatisfied", "somewhat dissatisfied" "satisfied". Scale range: 11-33. Higher DSSI scores represent more social support.

    Measured: Baseline, 6-months

  8. Functional Status Using the Duke Older Americans Resources and Services Procedures (OARS) Multidimensional Functional Assessment Questionnaire - Activities of Daily Living section

    The OARS Multidimensional Functional Assessment Questionnaire is a valid and reliable questionnaire, designed to assess the overall personal functional status and service use of older adults. Participants will be asked to respond to questions from the Activities of Daily Living section [14-items; activities of daily living (ADLs)/instrumental activities of daily living (IADLs)] of the OARS, which assesses both activities of daily living, such as eating, dressing and walking; and instrumental activities of daily living, such as using a telephone, shopping for groceries, and preparing meals. Response options include "without help", "with some help", and "completely unable". Scale range: 0-28. Higher scores represent a higher level of function.

    Measured: Baseline, 6-months

  9. Nutritional Status Using the Seniors in the Community Risk Evaluation for Eating and Nutrition tool (SCREEN II-AB)

    The Seniors in the Community Risk Evaluation for Eating and Nutrition tool (SCREEN II-AB) is an abbreviated, 8-item nutrition screening instrument for older adults living in the community, to identify individuals at risk for nutritional problems or who have poor nutritional status. Items assess for weight change in the past 6 months, intake of fruit, vegetables and fluid, meal consumption and preparation, appetite, and swallowing. Scale range: 0-52. Higher scores represent lower risk for nutritional problems.

    Measured: Baseline, 6-months

  10. Shared Decision-Making Using the CollaboRATE tool

    The CollaboRATE tool consists of 3 items that measure the level of shared decision-making in a clinical encounter from the patient's perspective. These items are: (i) How much effort was made to help you understand your health issues? (ii) How much effort was made to listen to what matters most to you about your health issues? (iii) How much effort was made to include what matters most to you in choosing what to do next? Participants are asked to rate their last appointment, on a 10-point scale from 0=No effort was made, to 9=Every effort was made. Scale range: 0-27. Higher scores represent a higher degree of shared decision-making.

    Measured: Baseline, 6-months

  11. Service Use Using the Health and Social Services Utilization Inventory (HSSUI)

    The Health and Social Services Utilization Inventory (HSSUI) will be used to assess service use of patients and caregivers. The HSSUI is a reliable and valid self-report questionnaire that measures the use of health and social services from a societal perspective. The HSSUI provides information on different categories of use including acute care service use such as emergency department visits and hospitalizations, use of nursing and allied health professionals, and visits to family doctors and specialists. As part of the HSSUI, diabetes and other medications, supplies and devices will also be assessed. Change in the use of health and social services will be assessed for patients and caregivers using the HSSUI. Patients (not caregivers) will be assessed for medication use using the HSSUI.

    Measured: Baseline, 6-months

  12. Glycated hemoglobin (HbA1c)

    Patients will be evaluated for glycated hemoglobin (HbA1c) as abstracted from their medical records. Values closest to the time frame will be used.

    Measured: Baseline, 6-months

  13. Glomerular Filtration Rate (GFR)

    Patients will be evaluated for glomerular filtration rate (GFR) as abstracted from their medical records. Values closest to the time frame will be used.

    Measured: Baseline, 6-months

  14. Low-Density Lipoprotein (LDL)

    Patients will be evaluated for low-density lipoprotein (LDL) as abstracted from their medical records. Values closest to the time frame will be used.

    Measured: Baseline, 6-months

  15. Collaboration Using the Partnership Self-Assessment Tool (PSAT)

    The Partnership Self-Assessment (PSAT) will be used to assess the collaboration process. The PSAT tool has shown acceptable validity and reliability. Questions ask about different aspects of the partnership, and the strengths and weaknesses of the collaboration process involved in the partnership (e.g., synergy, leadership, efficiency, administration and management etc.). Providers and managers will be evaluated for change in collaboration. Scale range: 1 - 5. Lower scores represent a lower level of collaboration.

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2018
  2. Study start1 Apr 2019
  3. Primary completion20 May 2022
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
A cross-jurisdictional, multi-site implementation-effectiveness type II hybrid randomized controlled trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03664583
Sponsor's protocol ID
KPG 156883
Acronym
ACHRU-CPP
Status last verified
Mar 2023
First submitted
23 Aug 2018
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40361198
  • 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.

    PubMed 39979911
  • 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.

    PubMed 37019487
  • 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.

    PubMed 35120457

Questions about this trial

What is this clinical trial studying?

A study testing ACHRU-Community Partnership Program (CPP) in people with Multiple Chronic Conditions and Diabetes Mellitus, run by McMaster University at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mental Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Mental Component Summary score. (time frame: Baseline, 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03664583, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.

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