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

February 9, 2023 updated by: Peter Selby, Centre for Addiction and Mental Health

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility - Recruitment Numbers
Time Frame: 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
Through the study completion, an average of 4 months
Feasibility - Participant characteristics
Time Frame: up to 8-weeks
The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics
up to 8-weeks
Feasibility - Participant Engagement (retention rate)
Time Frame: 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)
up to 8-weeks
Feasibility - Participant Engagement (intensity)
Time Frame: 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)
up to 8-weeks
Feasibility - Participant Engagement (drop out)
Time Frame: 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)
up to 8-weeks
Feasibility - Delivery of Intervention (Time with coach)
Time Frame: 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
up to 8-weeks
Feasibility - Delivery of Intervention (Mode of interaction)
Time Frame: 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)
up to 12-weeks
Feasibility - Delivery of Intervention (Coach strategies)
Time Frame: 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)
up to 12-weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Study Participant experience and satisfaction via semi-structured interview
Time Frame: up to 8-weeks
The secondary outcome consists of study participant experience/satisfaction.
up to 8-weeks
Care Coordinator experience and satisfaction via semi-structured interview
Time Frame: up to 8-weeks
The secondary outcome consists of Care Coordinator experience and satisfaction.
up to 8-weeks
Virtual Care Team experience and satisfaction via semi-structured interview
Time Frame: up to 8-weeks
The secondary outcome consists of Virtual Care Team experience and satisfaction.
up to 8-weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory Outcome - Health Behaviour metrics (physical activity)
Time Frame: 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.
up to 4-weeks
Exploratory Outcome - Health Behaviour metrics (diet)
Time Frame: up to 4-weeks
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)
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Substance Use (GAINS-SS)
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Substance Use (alcohol)
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Substance Use
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Mental Health (depression)
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Mental Health (Anxiety)
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Mental Health (Diabetes awareness/insight)
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Mental Health (Diabetes Distress)
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Mental Health (Stress)
Time Frame: 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).
up to 12-weeks
Exploratory Outcome - Quality of Life
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Quality of Life
Time Frame: 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.
up to 12-weeks
Exploratory Outcome - Waist circumference
Time Frame: up to 12-weeks
self-report
up to 12-weeks
Exploratory Outcome - BMI (height/weight)
Time Frame: up to 12-weeks
self-report
up to 12-weeks
Exploratory Outcome - Blood pressure
Time Frame: up to 12-weeks
self-report
up to 12-weeks
Exploratory Outcome - Current medication
Time Frame: up to 12-weeks
list
up to 12-weeks
Exploratory Outcome - Blood work
Time Frame: up to 12-weeks
Hemoglobin A1C levels
up to 12-weeks
Exploratory Outcome - Pain
Time Frame: up to 12-weeks
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
Time Frame: up to 12-weeks
months
up to 12-weeks
Exploratory Outcome - Diabetes self-management
Time Frame: up to 12-weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Addiction and Mental Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Selby, CAMH
  • Principal Investigator: Diana Sherifali, McMaster University
  • Principal Investigator: Farooq Naeem, CAMH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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