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Completed

NCT Number: NCT04607915

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAMH

Toronto, Ontario, M6J1H4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention for TECC Model

Behavioral

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.

Primary outcomes

  1. 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

  2. Feasibility - Participant characteristics

    Time frame: up to 8-weeks

    The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics

  3. 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)

  4. 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)

  5. 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)

  6. 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

  7. 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)

  8. 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)

Secondary outcomes

  1. Study Participant experience and satisfaction via semi-structured interview

    Time frame: up to 8-weeks

    The secondary outcome consists of study participant experience/satisfaction.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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.

  13. 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.

  14. Exploratory Outcome - Waist circumference

    Time frame: up to 12-weeks

    self-report

  15. Exploratory Outcome - BMI (height/weight)

    Time frame: up to 12-weeks

    self-report

  16. Exploratory Outcome - Blood pressure

    Time frame: up to 12-weeks

    self-report

  17. Exploratory Outcome - Current medication

    Time frame: up to 12-weeks

    list

  18. Exploratory Outcome - Blood work

    Time frame: up to 12-weeks

    Hemoglobin A1C levels

  19. 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).

  20. Exploratory Outcome - Diabetes duration

    Time frame: up to 12-weeks

    months

  21. 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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2020
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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