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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Intervention for TECC Model

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J1H4
      • CAMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Feasibility - Participant characteristics	The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics	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)	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)	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)	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	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)	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)	up to 12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Participant experience and satisfaction via semi-structured interview	The secondary outcome consists of study participant experience/satisfaction.	up to 8-weeks
Care Coordinator experience and satisfaction via semi-structured interview	The secondary outcome consists of Care Coordinator experience and satisfaction.	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.	up to 8-weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
Exploratory Outcome - Waist circumference	self-report	up to 12-weeks
Exploratory Outcome - BMI (height/weight)	self-report	up to 12-weeks
Exploratory Outcome - Blood pressure	self-report	up to 12-weeks
Exploratory Outcome - Current medication	list	up to 12-weeks
Exploratory Outcome - Blood work	Hemoglobin A1C levels	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).	up to 12-weeks
Exploratory Outcome - Diabetes duration	months	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.	up to 12-weeks

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Peter Selby, CAMH; Principal Investigator: Diana Sherifali, McMaster University; Principal Investigator: Farooq Naeem, CAMH

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 4, 2021
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (ACTUAL): October 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 104-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No