Technology-enabled Collaborative Care for Diabetes Management During COVID-19

Study Overview
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Brief Summary
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The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for type 2 diabetes designed to support patients with diabetes and mental health concerns during COVID-19.

Detailed Description
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There is growing concern regarding the impact of COVID-19 and social isolation on mental health and wellbeing, particularly adults living with type 2 diabetes (T2DM), who are at greater risk for mental health issues than the general population. Self-management education and support for healthy eating, physical activity, glucose monitoring, medication adherence and problem solving are vital components of diabetes care. Due to social distancing and limited care and resources, that are likely to persist in the post pandemic phase other innovative service models should be developed and adopted to improve service delivery. The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for T2DM designed to support patients with diabetes and mental health concerns during COVID-19.

Official Title
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Technology-enabled Collaborative Care for Diabetes (TECC-Diabetes) Management During COVID: A Feasibility Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Intervention for TECC Model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years and older Clinician diagnosis of Type 2 diabetes for at least one year A1C level of 7.5% or higher within the last 6 months (benchmark is 7%) Access to telephone or internet through computer or mobile Experiencing some distress, score of ** on Perceived Stress Scale Exclusion Criteria: Unable to provide consent Unable to understand English Pregnant or planning to get pregnant during the course of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention for TECC Model<br> | Behavioral: Intervention for TECC Model<br>* The Care Coordinator (CC) will provide brief coaching sessions (15 to 20 minutes) to each participant once per week for 8 weeks. Participants can identify topics for discussion and the CC and participant can decide if a video session via WebEx is required versus a phone call. Also, participants will be given peer support and will be indirectly monitored by a virtual care team of experts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Recruitment Numbers | The primary outcome in this study is feasibility, specifically process outcomes. This includes assessing recruitment number | Through the study completion, an average of 4 months | 
| Feasibility - Participant characteristics | The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics | up to 8-weeks | 
| Feasibility - Participant Engagement (retention rate) | The primary outcome in this study is feasibility, specifically process outcomes. This includes participant retention rate (e.g., defined by time between first and last visit) | up to 8-weeks | 
| Feasibility - Participant Engagement (intensity) | The primary outcome in this study is feasibility, specifically process outcomes. This includes intensity (e.g., number of session participants attend) | up to 8-weeks | 
| Feasibility - Participant Engagement (drop out) | The primary outcome in this study is feasibility, specifically process outcomes. This includes drop out (consented/enrolled but did not attend first one-on-one) | up to 8-weeks | 
| Feasibility - Delivery of Intervention (Time with coach) | The primary outcome in this study is feasibility, specifically process outcomes. This includes the amount of time a coach spends per interaction | up to 8-weeks | 
| Feasibility - Delivery of Intervention (Mode of interaction) | The primary outcome in this study is feasibility, specifically process outcomes. This includes the mode of the interaction (i.e., virtual, telephone or both) | up to 12-weeks | 
| Feasibility - Delivery of Intervention (Coach strategies) | The primary outcome in this study is feasibility, specifically process outcomes. This includes what strategies are used by the coach (i.e., educational, psychosocial support, behaviour modifications, or case management/monitoring) | up to 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Participant experience and satisfaction via semi-structured interview | The secondary outcome consists of study participant experience/satisfaction. | up to 8-weeks | 
| Care Coordinator experience and satisfaction via semi-structured interview | The secondary outcome consists of Care Coordinator experience and satisfaction. | up to 8-weeks | 
| Virtual Care Team experience and satisfaction via semi-structured interview | The secondary outcome consists of Virtual Care Team experience and satisfaction. | up to 8-weeks |