Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes

Study Overview
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Brief Summary
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The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers. Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.

Detailed Description
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Research Goal To examine the comparative effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with T2DM and Multiple Chronic Conditions and their family caregivers. Objectives To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services? To compare the effectiveness of the intervention on HRQoL, physical activity, nutritional status, depression, anxiety, diabetes parameters (blood glucose levels [HbA1c, hypoglycemic episodes]), diabetes-related complications, number of vascular events, social support number of falls, fall risk and medication safety with usual primary care services? To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care? To assess whether or not the intervention improves clinical practice behaviours? To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective? To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention? To determine the effectiveness of the intervention based on sex/gender and region? To determine the overall feasibility and acceptability of an IP community-based health promotion intervention and what can be identified as barriers and facilitators to implementation?

Official Title
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A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions

Conditions
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Type 2 Diabetes Mellitus, NIDDM, Non-insulin Dependent Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Home Visits and Lifestyle Education Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: older adults aged 65+ live in the local vicinity of a participating Diabetes Education Program were referred to their Diabetes Education Program within the past 24 months competence in English (or access to a translator) intention to continue living in the area for the next 6 months two reported chronic conditions in addition to T2DM. Individuals with newly diagnosed T2DM as well as those who were already receiving treatment for T2DM will be eligible for inclusion in the study. Exclusion Criteria: score of 20 or less in Montreal Cognitive Assessment (MoCA) test AND without access to a substitute decision maker to sign consent (Score of 20 or less is not in itself an exclusion).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Primary Care<br>Usual Primary Care will be received by half the participants during the course of the Study | |
| Active Comparator: Home Visits and educational support<br>Intervention comprised of Home Visits and group educational sessions. Home Visits and will be conducted by Diabetes Education staff in lieu of usual care conducted at the Diabetes clinic. Lifestyle support and educational will be offered in the form of monthly Diabetes Wellness Days offered in the community where nutrition, exercise and support will be given to help improve self-management of diabetes. | Behavioral: Home Visits and Lifestyle Education Support<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Diabetes Self-Care Activities | 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 items that assess the following aspects of the diabetes regimen: general and specific diet, exercise, blood-glucose testing, foot care, and smoking. Scores are calculated for each of these five regimen areas. This data is collected by the interventionists at each visit. | Every two months from study onset until the end of study (6 months from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF12v2 | This measurement is used to assess Health related quality of Life. This survey consists of 12 questions that measure functional health and well-being from the client's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health), and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores | Baseline and end of study (6 months from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-Management, Home Visits