Type1diabetesNCT05668507
REACHOUT Mental Health Support Mobile App
A study testing REACHOUT Virtual Mental Health Support in people with Type1diabetes, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type1diabetes
- What is being tested?
- REACHOUT Virtual Mental Health Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to 25 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Type1diabetes
- Being tested
- REACHOUT Virtual Mental Health Support
- Keywords
- mental health, type 1 diabetes, peer support, technology
- Medical subject headings
- Psychological Well-Being, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACHOUT Virtual Mental Health SupportBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6 month(s)
Secondary outcomes (9)
Change in Perceived social support
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.
Measured: 0, 6 month(s)
Change in Depressive Symptom Severity
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.
Measured: 0, 6 month(s)
Change in Resilience
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.
Measured: 0, 6 month(s)
Change in Diabetes-Specific Quality of Life
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.
Measured: 0, 6 month(s)
Change in Health-Related Quality of Life
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.
Measured: 0, 3, 6 month(s)
Change in Quality Adjusted Life year (QALY)
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'.
Measured: 0, 3, 6 month(s)
Change in Health Related Costs
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.
Measured: 0, 3, 6 month(s)
Change in Hemoglobin A1c
Hemoglobin A1c (HbA1c) will be measure via blood collection
Measured: 0, 6 month(s)
Change in % Time in Range
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.
Measured: 14 days before and after each participant's baseline and 6-month assessments, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start15 Jan 2024
- Primary completion25 Apr 2025 (estimated)
- Study completion25 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Brain Canada
- Responsible party
- Principal investigator, Tricia Tang, University of British Columbia
- Investigators
- Tricia S Tang, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668507
- Sponsor's protocol ID
- H22-02196
- Status last verified
- Nov 2024
- First submitted
- 8 Dec 2022
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05668507
- Acronym / sponsor ID
- H22-02196
- Conditions
- Type1diabetes
- Keywords
- mental health, type 1 diabetes, peer support, technology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Brain Canada
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 25 Apr 2025 (estimated)
- Study completion
- 25 Apr 2025 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| REACHOUT | Experimental | Behavioral: REACHOUT Virtual Mental Health SupportThe 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. |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REACHOUT Virtual Mental Health SupportREACHOUT 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 | Behavioural | REACHOUT |
Primary outcome
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.
9 secondary outcomes
Change in Perceived social support
Time frame: 0, 6 month(s)
Change in Depressive Symptom Severity
Time frame: 0, 6 month(s)
Change in Resilience
Time frame: 0, 6 month(s)
Change in Diabetes-Specific Quality of Life
Time frame: 0, 6 month(s)
Change in Health-Related Quality of Life
Time frame: 0, 3, 6 month(s)
Change in Quality Adjusted Life year (QALY)
Time frame: 0, 3, 6 month(s)
Change in Health Related Costs
Time frame: 0, 3, 6 month(s)
Change in Hemoglobin A1c
Time frame: 0, 6 month(s)
Change in % Time in Range
Time frame: 14 days before and after each participant's baseline and 6-month assessments, respectively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tricia S Tang, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACHOUT Virtual Mental Health Support in people with Type1diabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diabetes Distress (time frame: 0, 6 month(s)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.