NCT05668507

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

1.3 years

First QC Date

December 8, 2022

Last Update Submit

November 11, 2024

Conditions

Keywords

mental healthtype 1 diabetespeer supporttechnology

Outcome Measures

Primary Outcomes (1)

  • Change in Diabetes Distress

    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 Outcomes (9)

  • 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)

  • +4 more secondary outcomes

Study Arms (2)

REACHOUT

EXPERIMENTAL

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

Wait-list

NO INTERVENTION

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.

Interventions

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

REACHOUT

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Psychological Well-BeingDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Tricia S Tang, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 29, 2022

Study Start

January 15, 2024

Primary Completion

April 25, 2025

Study Completion

April 25, 2025

Last Updated

November 13, 2024

Record last verified: 2024-11

Locations