Clinical trial NCT05668507: REACHOUT Mental Health Support Mobile App
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type1diabetes
Keywords: mental health
type 1 diabetes
peer support
technology
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Brain Canada
First posted: 2022-12-29
Enrollment: 225
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the intervention group (access to the mobile app/support program right away) or the wait-list control group (access granted to the mobile app/support program after 6 months).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Diabetes Distress
timeFrame: 0, 6 month(s)
Secondary outcomes:
measure: Change in Perceived social support
timeFrame: 0, 6 month(s)
measure: Change in Depressive Symptom Severity
timeFrame: 0, 6 month(s)
measure: Change in Resilience
timeFrame: 0, 6 month(s)
measure: Change in Diabetes-Specific Quality of Life
timeFrame: 0, 6 month(s)
measure: Change in Health-Related Quality of Life
timeFrame: 0, 3, 6 month(s)
measure: Change in Quality Adjusted Life year (QALY)
timeFrame: 0, 3, 6 month(s)
measure: Change in Health Related Costs
timeFrame: 0, 3, 6 month(s)
measure: Change in Hemoglobin A1c
timeFrame: 0, 6 month(s)
measure: Change in % Time in Range
timeFrame: 14 days before and after each participant's baseline and 6-month assessments, respectively
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Tricia S Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: