REACHOUT Mental Health Support Mobile App

February 24, 2023 updated by: Tricia Tang, University of British Columbia

Using a Virtual Care Platform to Deliver Peer-led Mental Health Support to Rural and Remote Communities in BC: A Randomized Wait-list Controlled Trial of the REACHOUT Intervention

The purpose of this study is to investigate the effectiveness of participation in a 6-month peer-led mental health support program, delivered via a mobile app (REACHOUT), to adults with type 1 diabetes compared to a wait-list control condition. Participants will connect with a Peer-Supporter (an adult with type 1 diabetes trained in providing mental health support), and have access to the app features including a 24/7 chat room and face-to-face support delivered via virtual happy hours.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

REACHOUT is a mobile app which delivers peer-led mental health support to adults with type 1 diabetes. The mobile app has three support features:

  1. One-on-one support delivered by a Peer Supporter

    Peer Supporters are adults with type 1 diabetes who will be trained on providing support to other adults with type 1 diabetes on the app ("the participants"). Participants will be able to go through the peer supporter library, review their profiles, and choose their peer supporter.

  2. Group support delivered via a 24/7 chat room

    Peer Supporters and participants on the app will be able to chat 24/7 in the chat room about any topic ranging from feedback on new devices to traveling with diabetes. The chat room is monitored by healthcare professionals including a registered nurse and registered psychologist.

  3. Face to face support delivered via virtual happy hours

Virtual happy hours are educational presentations/discussions led by either a Peer Supporter or healthcare professional on topics related to diabetes.

Participants will be randomly assigned to the intervention group or the wait-list control group. The intervention group will be given access to the mobile app right away and the wait-list control group will be given access to the mobile app after six months.

The intervention is 6 months long. All participants and Peer Supporters will go through an assessment at the start and end of the program. The assessment includes a blood draw to measure hemoglobin A1c, and questionnaires measuring diabetes distress, perceived social support, depressive symptoms, resilience, quality of life, and costs related to diabetes. There will also be questionnaires throughout the program including at 1-month and 3-months. Participants and Peer Supporters who own a Dexcom G6 continuous glucose monitor (CGM) will be asked if they would like to share their CGM data.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia

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

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have type 1 diabetes (T1D)
  • be 19 years or older
  • reside in one of the targeted health authorities in British Columbia (Fraser Health, Island Health, Northern Health, and Interior Health Authorities)
  • be English proficient
  • have an average diabetes distress (DD) Subscale Score ≥ 2
  • have access to the internet and/or a smartphone.

Exclusion Criteria:

  • Participants with a pre-existing mental health condition, multiple co-morbidities, substance use challenges, and or any other condition that may prevent meaningful participation may not participate in this 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REACHOUT
The REACHOUT intervention arm will receive access to the REACHOUT mobile app through which they will be able to review profiles of Peer Supporters and connect with one of their choosing. They will also have access to the other app features including a 24/7 chat room and face-to-face support via virtual happy hours. Participants will complete questionnaires (baseline, 1 month, 3 months, 6 months) and a blood draw (baseline and 6 months). Monetary compensation will be provided for their time and effort.
Behavioral: REACHOUT Virtual Mental Health Support

REACHOUT is a mobile app which delivers peer-led mental health support to adults with type 1 diabetes. The mobile app has three support features:

  1. One-on-one support delivered by a Peer Supporter. Participants will be able to review Peer Supporter profiles and connect with one of their choosing.
  2. Group support delivered via a 24/7 chat room
  3. Face to face support delivered via virtual happy hours
No Intervention: Wait-list
The wait-list control group will receive access to the mobile app/support program after six (6) months. They will complete questionnaires and a blood draw at baseline and 6 months. Monetary compensation will be provided for their time and effort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diabetes Distress
Time Frame: 0, 6 month(s)
Diabetes Distress will be measured by the Type 1 Diabetes Distress Scale (T1D-DDS). This scale contains 28 items that people with type 1 diabetes may find distressing. Participants rate each item on a scale from 1 indicating Not a Problem to 6 indicating a Very Serious Problem. There are seven subscales including powerlessness, management distress, hypoglycemia distress, negative social distress, eating distress, physician distress, and family/friends distress. Overall and subscale scores are calculated by taking the mean of items in the overall or subscale. A higher score indicates higher diabetes distress.
0, 6 month(s)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perceived social support
Time Frame: 0, 6 month(s)
Perceived Social Support will be assessed using the Diabetes-Specific Perceived Social Support Scale. This scale presents a list of ways that people give and receive support, and asks participants to indicate the degree to which each statement is true for them. Participants may rate each item from 0 indicating No Support to 4 indicating a Great Deal of Support. A higher score indicates higher perceived social support.
0, 6 month(s)
Change in Depressive Symptom Severity
Time Frame: 0, 6 month(s)
Depressive Symptom Severity will be assessed using the Personal Health Questionnaire 8 (PHQ-8). This questionnaire asks participants how bothered they have been by various problems over the past two weeks. Participants rate each item from 0 indicating Not At All to 3 indicating Nearly Every Day. A total score is calculated by adding up the ratings for each item. A higher score indicates higher depressive symptom severity.
0, 6 month(s)
Change in Resilience
Time Frame: 0, 6 month(s)
Resilience will be assessed by the Diabetes Strengths and Resilience (DSTAR) Measure for Emerging Adults. The scale presents a list of items that people with diabetes sometimes think. Items are scored on a 5-point Likert scale from never "1" to almost always "5". A total score is calculated by taking a sum of all items. A higher score indicates higher resilience.
0, 6 month(s)
Change in Diabetes-Specific Quality of Life
Time Frame: 0, 6 month(s)
Diabetes-Specific Quality of Life will be measured by the Type 1 Diabetes Activities and Living (T1DAL). The survey questions ask participants what their life is like with diabetes including what is going well for them or what they could use more help with. There are different variations of the questionnaire for each of the following age cohorts: 18 - 25 years old, 26 - 45 years old, 46 - 60 years old, > 60 years old. Participants answer each item with the following options: (1) No, not at all true; (2) No, not very true; (3) Sometimes true, sometimes not true; (4) Yes, a little true; (5) Yes, very true.
0, 6 month(s)
Change in Health-Related Quality of Life
Time Frame: 0, 3, 6 month(s)
Health-Related Quality of Life will be measured by the EuroQol-5D-5 level version (EQ-5D-5L), which asks questions regarding general health. Participants are asked to choose from a variety of statements for each question which best describes their health.
0, 3, 6 month(s)
Change in Quality Adjusted Life year (QALY)
Time Frame: 0, 3, 6 month(s)
Change Quality Adjusted Life Year (QALY) will be estimated using the Visual Analogue Scale (VAS) of the EuroQol-5D-5 level version (EQ-5D-5L). The VAS asks participants to self-rate their health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
0, 3, 6 month(s)
Change in Health Related Costs
Time Frame: 0, 3, 6 month(s)
Change in Health Related Costs will be measured by the Health Resource Utilization Questionnaire (HRU). This questionnaire asks a series of questions regarding health resource utilization and costs patients may have incurred.
0, 3, 6 month(s)
Change in Hemoglobin A1c
Time Frame: 0, 6 month(s)
Hemoglobin A1c (HbA1c) will be measure via blood collection
0, 6 month(s)
Change in % Time in Range
Time Frame: Up to 6 months
In British Columbia, the continuous glucose monitor (CGM) brand that is covered by provincial health care is the Dexcom G6. As such, we will request to collect % time in range data from all participants who are using this CGM. Because the G6 CGM is pre-calibrated by the factory, participants do not need to self-calibrate. CGM units will be retrieved by the research team every two weeks using Dexcom Clarity software (Dexcom, San Diego, CA).
Up to 6 months

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

Juvenile Diabetes Research Foundation
Brain Canada

Investigators

  • Principal Investigator: Tricia S Tang, PhD, University of British Columbia

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 (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

December 29, 2022

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H22-02196

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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