An interventional study of Intervention for TECC Model in Type 2 Diabetes, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Supportive care
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 31 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Centre for Addiction and Mental Health is the lead sponsor of 339 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Behavioral: Intervention for TECC Model
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.
Feasibility - Recruitment Numbers
The primary outcome in this study is feasibility, specifically process outcomes. This includes assessing recruitment number
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: up to 12-weeks
Study Participant experience and satisfaction via semi-structured interview
The secondary outcome consists of study participant experience/satisfaction.
Time frame: up to 8-weeks
Care Coordinator experience and satisfaction via semi-structured interview
The secondary outcome consists of Care Coordinator experience and satisfaction.
Time frame: 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.
Time frame: up to 8-weeks
Exploratory Outcome - Health Behaviour metrics (physical activity)
The exploratory outcomes will include Health Behaviour metrics via International Physical Activity Questionnaire). Individual scores per question, the higher the score means the higher the level of physical activity.
Time frame: up to 4-weeks
Exploratory Outcome - Health Behaviour metrics (diet)
The exploratory outcomes will include Health Behaviour metrics (via Mediterranean Diet Adherence Screener Modified (MEDAS modified)
Time frame: up to 4-weeks
Exploratory Outcome - Health Behaviour metrics (confidence/importance to change behaviour)
The exploratory outcomes will include Health Behaviour metrics (via readiness to change ruler (smoking, alcohol, nutrition, physical activity). Minimum score: 0; maximum score: 10; higher score represented a better outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Substance Use (GAINS-SS)
The exploratory outcomes will include substance use (via GAINS-SS (Global Appraisal of Individual Needs- Short Screener). Minimum score: 0; maximum score: 20; higher score represented a worse outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Substance Use (alcohol)
The exploratory outcomes will include substance use (Alcohol Use Disorders Identification Test (AUDIT); Minimum score: 0; maximum score: 40; higher score represented a worse outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Substance Use
The exploratory outcomes will include substance use (via heaviness of smoking index - 2 items out of Fagerstrom test for nicotine dependence (FTND)); Minimum score: 0; maximum score: 6; higher score represented a worse outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Mental Health (depression)
The exploratory outcomes will include Mental Health measures (via Patient Health Questionnaire (PHQ-9)). Minimum score: 0; maximum score: 27; higher score represented a worse outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Mental Health (Anxiety)
The exploratory outcomes will include Mental Health measures via Generalized Anxiety Disorder-7 (GAD-7). Minimum score: 0; maximum score: 21; higher score represented a worse outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Mental Health (Diabetes awareness/insight)
The exploratory outcomes will include Mental Health measures via Diabetes awareness and insight scale. Minimum score: 0; maximum score: 10; higher score represented a better outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Mental Health (Diabetes Distress)
The exploratory outcomes will include Mental Health measures via Diabetes Distress Scale. Minimum score: 0; maximum score: 6; higher score represented a worse outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Mental Health (Stress)
The exploratory outcomes will include Mental Health measures via perceived stress scale (PSS). Minimum score: 0; maximum score: 40; higher score represented a worse outcome (i.e., higher perceived stress).
Time frame: up to 12-weeks
Exploratory Outcome - Quality of Life
The exploratory outcomes will include quality of life (via European Quality of Life - 5 Dimensions scale - EQ5D). Minimum score: 0; maximum score: 100; higher score represented a better outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Quality of Life
The exploratory outcomes will include quality of life (via Verona satisfaction scale). Minimum score: 0; higher score represented a better outcome.
Time frame: up to 12-weeks
Exploratory Outcome - Waist circumference
self-report
Time frame: up to 12-weeks
Exploratory Outcome - BMI (height/weight)
self-report
Time frame: up to 12-weeks
Exploratory Outcome - Blood pressure
self-report
Time frame: up to 12-weeks
Exploratory Outcome - Current medication
list
Time frame: up to 12-weeks
Exploratory Outcome - Blood work
Hemoglobin A1C levels
Time frame: up to 12-weeks
Exploratory Outcome - Pain
Brief Pain Inventory-sf. Minimum score: 0; maximum score: 10; higher score represented a worse outcome (i.e., more pain).
Time frame: up to 12-weeks
Exploratory Outcome - Diabetes duration
months
Time frame: up to 12-weeks
Exploratory Outcome - Diabetes self-management
Diabetes Self-Management and Technology Questionnaire (DSMT-Q); Minimum score: 0; maximum score: 48; higher score represented a worse outcome.
Time frame: up to 12-weeks
Ran from May 2021 to primary completion in Jun 2022, 13 months.
Of 1,924 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's 13 months is below that.
Counting every sponsor, half of 2,101 studies reached it within 20 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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