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Clinical Trials/NCT04607915
NCT04607915
Completed
N/A

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

Centre for Addiction and Mental Health1 site in 1 country31 target enrollmentMay 4, 2021
ConditionsType 2 Diabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Centre for Addiction and Mental Health
Enrollment
31
Locations
1
Primary Endpoint
Feasibility - Delivery of Intervention (Time with coach)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2021
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter Selby

Clinician Scientist

Centre for Addiction and Mental Health

Eligibility Criteria

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

Outcomes

Primary Outcomes

Feasibility - Delivery of Intervention (Time with coach)

Time Frame: up to 8-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes the amount of time a coach spends per interaction

Feasibility - Recruitment Numbers

Time Frame: Through the study completion, an average of 4 months

The primary outcome in this study is feasibility, specifically process outcomes. This includes assessing recruitment number

Feasibility - Delivery of Intervention (Coach strategies)

Time Frame: up to 12-weeks

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)

Feasibility - Participant characteristics

Time Frame: up to 8-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics

Feasibility - Participant Engagement (retention rate)

Time Frame: up to 8-weeks

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)

Feasibility - Delivery of Intervention (Mode of interaction)

Time Frame: up to 12-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes the mode of the interaction (i.e., virtual, telephone or both)

Feasibility - Participant Engagement (intensity)

Time Frame: up to 8-weeks

The primary outcome in this study is feasibility, specifically process outcomes. This includes intensity (e.g., number of session participants attend)

Feasibility - Participant Engagement (drop out)

Time Frame: up to 8-weeks

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)

Secondary Outcomes

  • Study Participant experience and satisfaction via semi-structured interview(up to 8-weeks)
  • Virtual Care Team experience and satisfaction via semi-structured interview(up to 8-weeks)
  • Care Coordinator experience and satisfaction via semi-structured interview(up to 8-weeks)

Study Sites (1)

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