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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607915
• Other study ID #: 104-2020
• Status: Completed
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	CAMH	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	up to 4-weeks
Other	Exploratory Outcome - Health Behaviour metrics (diet)	The exploratory outcomes will include Health Behaviour metrics (via Mediterranean Diet Adherence Screener Modified (MEDAS modified)	up to 4-weeks
Other	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.	up to 12-weeks
Other	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.	up to 12-weeks
Other	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.	up to 12-weeks
Other	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.	up to 12-weeks
Other	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.	up to 12-weeks
Other	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.	up to 12-weeks
Other	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.	up to 12-weeks
Other	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.	up to 12-weeks
Other	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).	up to 12-weeks
Other	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.	up to 12-weeks
Other	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.	up to 12-weeks
Other	Exploratory Outcome - Waist circumference	self-report	up to 12-weeks
Other	Exploratory Outcome - BMI (height/weight)	self-report	up to 12-weeks
Other	Exploratory Outcome - Blood pressure	self-report	up to 12-weeks
Other	Exploratory Outcome - Current medication	list	up to 12-weeks
Other	Exploratory Outcome - Blood work	Hemoglobin A1C levels	up to 12-weeks
Other	Exploratory Outcome - Pain	Brief Pain Inventory-sf. Minimum score: 0; maximum score: 10; higher score represented a worse outcome (i.e., more pain).	up to 12-weeks
Other	Exploratory Outcome - Diabetes duration	months	up to 12-weeks
Other	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.	up to 12-weeks
Primary	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
Primary	Feasibility - Participant characteristics	The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics	up to 8-weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Study Participant experience and satisfaction via semi-structured interview	The secondary outcome consists of study participant experience/satisfaction.	up to 8-weeks
Secondary	Care Coordinator experience and satisfaction via semi-structured interview	The secondary outcome consists of Care Coordinator experience and satisfaction.	up to 8-weeks
Secondary	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