Clinical trial NCT04607915: Technology-enabled Collaborative Care for Diabetes Management During COVID-19
Official title: Technology-enabled Collaborative Care for Diabetes (TECC-Diabetes) Management During COVID: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility - Recruitment Numbers
timeFrame: Through the study completion, an average of 4 months
measure: Feasibility - Participant characteristics
timeFrame: up to 8-weeks
measure: Feasibility - Participant Engagement (retention rate)
timeFrame: up to 8-weeks
measure: Feasibility - Participant Engagement (intensity)
timeFrame: up to 8-weeks
measure: Feasibility - Participant Engagement (drop out)
timeFrame: up to 8-weeks
measure: Feasibility - Delivery of Intervention (Time with coach)
timeFrame: up to 8-weeks
measure: Feasibility - Delivery of Intervention (Mode of interaction)
timeFrame: up to 12-weeks
measure: Feasibility - Delivery of Intervention (Coach strategies)
timeFrame: up to 12-weeks
Secondary outcomes:
measure: Study Participant experience and satisfaction via semi-structured interview
timeFrame: up to 8-weeks
measure: Care Coordinator experience and satisfaction via semi-structured interview
timeFrame: up to 8-weeks
measure: Virtual Care Team experience and satisfaction via semi-structured interview
timeFrame: up to 8-weeks
Other outcomes:
measure: Exploratory Outcome - Health Behaviour metrics (physical activity)
timeFrame: up to 4-weeks
measure: Exploratory Outcome - Health Behaviour metrics (diet)
timeFrame: up to 4-weeks
measure: Exploratory Outcome - Health Behaviour metrics (confidence/importance to change behaviour)
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Substance Use (GAINS-SS)
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Substance Use (alcohol)
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Substance Use
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Mental Health (depression)
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Mental Health (Anxiety)
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Mental Health (Diabetes awareness/insight)
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Mental Health (Diabetes Distress)
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Mental Health (Stress)
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Quality of Life
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Quality of Life
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Waist circumference
timeFrame: up to 12-weeks
measure: Exploratory Outcome - BMI (height/weight)
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Blood pressure
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Current medication
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Blood work
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Pain
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Diabetes duration
timeFrame: up to 12-weeks
measure: Exploratory Outcome - Diabetes self-management
timeFrame: up to 12-weeks
Locations:
city: Toronto
country: Canada
facility: CAMH
state: Ontario
Study officials:
affiliation: CAMH
name: Peter Selby
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Diana Sherifali
role: PRINCIPAL_INVESTIGATOR
affiliation: CAMH
name: Farooq Naeem
role: PRINCIPAL_INVESTIGATOR
References: