Technology-enabled Collaborative Care for Diabetes Management During COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention for TECC Model
|
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.
|
Outcome Measures
Primary Outcome Measures
- Feasibility - Recruitment Numbers [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 - Participant characteristics [up to 8-weeks]
The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics
- Feasibility - Participant Engagement (retention rate) [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 - Participant Engagement (intensity) [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) [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)
- Feasibility - Delivery of Intervention (Time with coach) [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 - Delivery of Intervention (Mode of interaction) [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 - Delivery of Intervention (Coach strategies) [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)
Secondary Outcome Measures
- Study Participant experience and satisfaction via semi-structured interview [up to 8-weeks]
The secondary outcome consists of study participant experience/satisfaction.
- Care Coordinator experience and satisfaction via semi-structured interview [up to 8-weeks]
The secondary outcome consists of Care Coordinator experience and satisfaction.
- Virtual Care Team experience and satisfaction via semi-structured interview [up to 8-weeks]
The secondary outcome consists of Virtual Care Team experience and satisfaction.
Other Outcome Measures
- Exploratory Outcome - Health Behaviour metrics (physical activity) [up to 4-weeks]
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.
- Exploratory Outcome - Health Behaviour metrics (diet) [up to 4-weeks]
The exploratory outcomes will include Health Behaviour metrics (via Mediterranean Diet Adherence Screener Modified (MEDAS modified)
- Exploratory Outcome - Health Behaviour metrics (confidence/importance to change behaviour) [up to 12-weeks]
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.
- Exploratory Outcome - Substance Use (GAINS-SS) [up to 12-weeks]
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.
- Exploratory Outcome - Substance Use (alcohol) [up to 12-weeks]
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.
- Exploratory Outcome - Substance Use [up to 12-weeks]
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.
- Exploratory Outcome - Mental Health (depression) [up to 12-weeks]
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.
- Exploratory Outcome - Mental Health (Anxiety) [up to 12-weeks]
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.
- Exploratory Outcome - Mental Health (Diabetes awareness/insight) [up to 12-weeks]
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.
- Exploratory Outcome - Mental Health (Diabetes Distress) [up to 12-weeks]
The exploratory outcomes will include Mental Health measures via Diabetes Distress Scale. Minimum score: 0; maximum score: 6; higher score represented a worse outcome.
- Exploratory Outcome - Mental Health (Stress) [up to 12-weeks]
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).
- Exploratory Outcome - Quality of Life [up to 12-weeks]
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.
- Exploratory Outcome - Quality of Life [up to 12-weeks]
The exploratory outcomes will include quality of life (via Verona satisfaction scale). Minimum score: 0; higher score represented a better outcome.
- Exploratory Outcome - Waist circumference [up to 12-weeks]
self-report
- Exploratory Outcome - BMI (height/weight) [up to 12-weeks]
self-report
- Exploratory Outcome - Blood pressure [up to 12-weeks]
self-report
- Exploratory Outcome - Current medication [up to 12-weeks]
list
- Exploratory Outcome - Blood work [up to 12-weeks]
Hemoglobin A1C levels
- Exploratory Outcome - Pain [up to 12-weeks]
Brief Pain Inventory-sf. Minimum score: 0; maximum score: 10; higher score represented a worse outcome (i.e., more pain).
- Exploratory Outcome - Diabetes duration [up to 12-weeks]
months
- Exploratory Outcome - Diabetes self-management [up to 12-weeks]
Diabetes Self-Management and Technology Questionnaire (DSMT-Q); Minimum score: 0; maximum score: 48; higher score represented a worse outcome.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CAMH | Toronto | Ontario | Canada | M6J1H4 |
Sponsors and Collaborators
- Centre for Addiction and Mental Health
Investigators
- Principal Investigator: Peter Selby, CAMH
- Principal Investigator: Diana Sherifali, McMaster University
- Principal Investigator: Farooq Naeem, CAMH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 104-2020