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Active, Not Recruiting

NCT Number: NCT05668507

REACHOUT Mental Health Support Mobile App

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, Canada

About this study

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:

  • 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.

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REACHOUT Virtual Mental Health Support

Behavioral

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:

  • 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.
  • Group support delivered via a 24/7 chat room
  • Face to face support delivered via virtual happy hours

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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'.

  7. 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.

  8. Change in Hemoglobin A1c

    Time frame: 0, 6 month(s)

    Hemoglobin A1c (HbA1c) will be measure via blood collection

  9. Change in % Time in Range

    Time frame: 14 days before and after each participant's baseline and 6-month assessments, respectively

    In British Columbia, the continuous glucose monitor (CGM) brands that are covered by provincial health care are the Dexcom G6, G7, and Freestyle Libre 2. As such, we will request to collect % time in range data from all participants who are using this CGM. Because the CGMs are pre-calibrated by the factory, participants do not need to self-calibrate. CGM units will be retrieved by the research team using Dexcom Clarity software (Dexcom, San Diego, CA), LibreView. We will also request participants who are using Glooko to share their data with us by uploading their data onto their Glooko account. In order to understand blood glucose fluctuations, we will collect 14 days of CGM glucose data at two timepoints: 1) baseline and 2) 6 months. The first day will be considered as the date of the baseline and 6-month assessments.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Brain Canada
  • Juvenile Diabetes Research Foundation

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2022
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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