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

NCT04607915 | Completed

• 1 other identifier: 104-2020
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Study Participant experience and satisfaction via semi-structured interview

  up to 8-weeks

• Care Coordinator experience and satisfaction via semi-structured interview

  up to 8-weeks

• Virtual Care Team experience and satisfaction via semi-structured interview

  up to 8-weeks

Other Outcomes (21)

• Exploratory Outcome - Health Behaviour metrics (physical activity)

  up to 4-weeks

• Exploratory Outcome - Health Behaviour metrics (diet)

  up to 4-weeks

• Exploratory Outcome - Health Behaviour metrics (confidence/importance to change behaviour)

  up to 12-weeks

Study Arms (1)

Intervention for TECC Model

EXPERIMENTAL

Behavioral: Intervention for TECC Model

Interventions

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.

Intervention for TECC Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide consent
• Unable to understand English
• Pregnant or planning to get pregnant during the course of the study

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

CAMH

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (1)

• Vojtila L, Sherifali D, Dragonetti R, Ashfaq I, Veldhuizen S, Naeem F, Agarwal SM, Melamed OC, Crawford A, Gerretsen P, Hahn M, Hill S, Kidd S, Mulsant B, Serhal E, Tackaberry-Giddens L, Whitmore C, Marttila J, Tang F, Ramdass S, Lourido G, Sockalingam S, Selby P. Technology-Enabled Collaborative Care for Concurrent Diabetes and Distress Management During the COVID-19 Pandemic: Protocol for a Mixed Methods Feasibility Study. JMIR Res Protoc. 2023 Jan 17;12:e39724. doi: 10.2196/39724.

  PMID: 36649068 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Peter Selby

  CAMH

  PRINCIPAL INVESTIGATOR

• Diana Sherifali

  McMaster University

  PRINCIPAL INVESTIGATOR

• Farooq Naeem

  CAMH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: October 29, 2020
• Study Start: May 4, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

CA (1)