An interventional study of ACHRU-Community Partnership Program (CPP) in Multiple Chronic Conditions and Diabetes Mellitus, sponsored by McMaster University. Status unknown at 4 sites in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by McMaster University · Not applicable, Interventional, and Health services research
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.
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 295 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Patient participants ("CPP Target Population") will be included in the study if they meet the following inclusion criteria:
Caregiver participants will be included in the study if they meet the following inclusion criteria:
Provider and manager participants will be included in the study if they meet the following inclusion criteria:
Patient, Public and Community Research Partner participants will be included in the study if they meet the following inclusion criteria:
Exclusion Criteria:
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)
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.
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.
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: Baseline, 6-months
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.
Time frame: 6-months
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