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Clinical Trials/NCT05668507
NCT05668507Active, not recruitingNot Applicable

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

University of British Columbia1 site in 1 country225 target enrollmentStarted: January 15, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
225
Locations
1
Primary Endpoint
Change in Diabetes Distress

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in Perceived social support(0, 6 month(s))
  • Change in Depressive Symptom Severity(0, 6 month(s))
  • Change in Resilience(0, 6 month(s))
  • Change in Diabetes-Specific Quality of Life(0, 6 month(s))
  • Change in Health-Related Quality of Life(0, 3, 6 month(s))
  • Change in Quality Adjusted Life year (QALY)(0, 3, 6 month(s))
  • Change in Health Related Costs(0, 3, 6 month(s))
  • Change in Hemoglobin A1c(0, 6 month(s))
  • Change in % Time in Range(14 days before and after each participant's baseline and 6-month assessments, respectively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tricia Tang

Principal Investigator

University of British Columbia

Study Sites (1)

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