Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664583
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborators:
Diabetes Action Canada
Scarborough Health Network
McMaster Institute for Research on Aging
Reseau-1 Quebec
McMaster University, School of Nursing
Health & Wellness Prince Edward Island (PEI)
Ontario Ministry of Health and Long Term Care
Care First Seniors & Community Services
Laval University Family Medicine Group of Saint-Charles Borromee Quebec
Quebec Strategy for Patient-Oriented Research (SPOR) SUPPORT Unit
Primary Care & Chronic Disease, Health PEI
Saint-Francois d'Assise Family Practice Teaching Unit
Department of Family Medicine and Emergency Medicine
Central East Local Health Integration Network
Institute for Clinical Evaluative Sciences
Alberta Innovates Health Solutions
Fonds de recherche du Quebec - Sante
St. Michael's Academic Family Health Team
Better Access and Care for Complex Needs (BeACCoN)
YMCA of Greater Toronto
Alberta SPOR Primary and Integrated Health Care Innovation Network (PIHCIN)
Alberta Health Services
PEI PIHCIN
Women's College Hospital - Women's Xchange
Ministere de la Sante et des Services Sociaux
Fédération de l'Âge d'Or du Québec (FADOQ) Region Lanaudiere Quebec
Toronto Central Local Health Integration Network
Information provided by (Responsible Party):
Jenny Ploeg, McMaster University

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 visits by nurses and dietitians, monthly group wellness sessions at community centers, and monthly team meetings. Wellness sessions include exercise, education, shared meals, 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.

Condition or disease Intervention/treatment Phase
Multiple Chronic Conditions Diabetes Mellitus Behavioral: ACHRU-Community Partnership Program (CPP) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A cross-jurisdictional, multi-site implementation-effectiveness type II hybrid randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: ACHRU Community Partnership Program for Diabetes Self-Management for Older Adults - Canada
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Intervention Group
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 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; 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)
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.

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Change in Mental Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Mental health component [ Time Frame: Baseline, 6-months, 12-months ]
    The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess change in 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 and mental component summary 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'). Patients (and caregivers) will be evaluated for change in SF-12 - Mental health component. Total scale range: 0 - 100. Two items compose the mental health score with a range of 2 - 10. Higher scores represent a better quality of life.


Secondary Outcome Measures :
  1. Change in Self-Management Using the Summary of Diabetes Self-Care Activities (SDSCA) [ Time Frame: Baseline, 6-months, 12-months ]
    The Summary of Diabetes Self-Care Activities (SDSCA) will be used to asses change in 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.

  2. Change in Physical Health Using the Short-Form 12 Health Survey Version 2 (SF-12v2) - Physical health component [ Time Frame: Baseline, 6-months, 12-months ]
    The Short-Form 12 Health Survey Version 2 (SF-12v2) tool will be used to assess change in 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 and mental component summary 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'). Patients and caregivers will be evaluated for change in quality of life - physical health using the SF-12. Total scale range: 0 - 100. Two items compose the physical health score with a range of 2 - 10. Higher scores represent a better quality of life.

  3. Change in Depressive Symptoms Using the Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10) [ Time Frame: Baseline, 6-months, 12-months ]
    The Center for Epidemiologic Studies on Depression 10-Item Scale (CES-D-10) will be used to assess change in depressive symptoms. This tool has been used in prior studies of older adults with mood disorders, has a high degree of reliability and validity, distinguishes between depressed and non-depressed people, and is a sensitive tool for measuring changes in depressive symptoms over time in psychiatric populations. 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.

  4. Change in Level of Anxiety Using the Generalized Anxiety Disorder 7-Item (GAD-7) [ Time Frame: Baseline, 6-months, 12-months ]
    The Generalized Anxiety Disorder 7-Item (GAD-7) will be used to assess change in 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', 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.

  5. Change in Mobility Using the Short Performance Physical Battery (SPPB) [ Time Frame: Baseline, 6-months, 12-months ]
    The Short Performance Physical Battery (SPPB) tool will be used to assess change in mobility of patients. The SPPB is a tool that measures patients mobility and lower function through a series of tests including chair stands, balance tests, and a walk test. The total SPPB score is summed across the three tests. Patients will be evaluated for change in mobility using SPPB tool. Higher scores represent better physical function.

  6. Change in Physical Activity Using the Physical Activity Scale for the Elderly (PASE) [ Time Frame: Baseline, 6-months, 12-months ]
    The Physical Activity Scale for the Elderly (PASE) tool will be used to assess change in 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.

  7. Change in Caregiver Strain Using the Modified Caregiver Strain Index (MCSI) [ Time Frame: Baseline, 6-months, 12-months ]
    The Modified Caregiver Strain Index (MCSI) will be used to assess change in 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.

  8. Change in Service Use Using the Health and Social Services Utilization Inventory (HSSUI) [ Time Frame: Baseline, 6-months, 12-months ]
    The Health and Social Services Utilization Inventory (HSSUI) will be used to asses change in 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. Only patients will additionally be assessed for change in medication use using the HSSUI.

  9. Change in Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline, 6-months, 12-months ]
    Patients will be evaluated for change in glycosylated hemoglobin (HbA1c) as abstracted from their medical records. Values closest to the time frame will be used.

  10. Change in Glomerular Filtration Rate (GFR) [ Time Frame: Baseline, 6-months, 12-months ]
    Patients will be evaluated for change in their glomerular filtration rate (GFR) as abstracted from their medical records. Values closest to the time frame will be used.

  11. Change in Low-Density Lipoprotein (LDL) [ Time Frame: Baseline, 6-months, 12-months ]
    Patients will be evaluated for change in their low-density lipoprotein (LDL) as abstracted from their medical records. Values closest to the time frame will be used.

  12. Change in Diabetes-Related Complications [ Time Frame: Baseline, 6-months, 12-months ]
    Patients will be assessed for change in type and severity of three diabetes-related complications: diabetic retinopathy, peripheral neuropathy, and peripheral vascular disease based on their self-report.

  13. Change in Collaboration Using the Partnership Self-Assessment Tool (PSAT) [ Time Frame: 6-months, 12-months ]
    The Partnership Self-Assessment (PSAT) will be used to assess change in 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 worse outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664583


Contacts
Layout table for location contacts
Contact: Tracey Chambers, RN, MSc (905) 525-9140 ext 21626 chambt@mcmaster.ca
Contact: Laurie Kennedy, MPA (905) 525-9140 ext 22392 kennedyl@mcmaster.ca

Sponsors and Collaborators
McMaster University
Diabetes Action Canada
Scarborough Health Network
McMaster Institute for Research on Aging
Reseau-1 Quebec
McMaster University, School of Nursing
Health & Wellness Prince Edward Island (PEI)
Ontario Ministry of Health and Long Term Care
Care First Seniors & Community Services
Laval University Family Medicine Group of Saint-Charles Borromee Quebec
Quebec Strategy for Patient-Oriented Research (SPOR) SUPPORT Unit
Primary Care & Chronic Disease, Health PEI
Saint-Francois d'Assise Family Practice Teaching Unit
Department of Family Medicine and Emergency Medicine
Central East Local Health Integration Network
Institute for Clinical Evaluative Sciences
Alberta Innovates Health Solutions
Fonds de recherche du Quebec - Sante
St. Michael's Academic Family Health Team
Better Access and Care for Complex Needs (BeACCoN)
YMCA of Greater Toronto
Alberta SPOR Primary and Integrated Health Care Innovation Network (PIHCIN)
Alberta Health Services
PEI PIHCIN
Women's College Hospital - Women's Xchange
Ministere de la Sante et des Services Sociaux
Fédération de l'Âge d'Or du Québec (FADOQ) Region Lanaudiere Quebec
Toronto Central Local Health Integration Network
Investigators
Layout table for investigator information
Principal Investigator: Jenny Ploeg, RN, PhD McMaster University
Study Director: Maureen Markle-Reid, RN, PhD McMaster University
Study Director: Ruta Valaitis, RN, PhD McMaster University

Layout table for additonal information
Responsible Party: Jenny Ploeg, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03664583     History of Changes
Other Study ID Numbers: KPG 156883
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jenny Ploeg, McMaster University:
Diabetes Mellitus, Type 2
Comorbidity
Aged
Health Services

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Multiple Chronic Conditions
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Chronic Disease
Disease Attributes
Pathologic Processes