Clinical trial NCT06308549: MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY)
Official title: MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY): A Multi-National Randomised-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Diabetes Distress
Keywords: Type 1 Diabetes
Diabetes Distress
Self-help
e-health
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: King's College London
name: University of Malaga
name: Forschungsinstitut der Diabetes Akademie Mergentheim
First posted: 2024-03-13
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the MyREMEDY study the investigators research whether the MyDiaMate self-help application is effective in strengthening the mental health of adults with type 1 diabetes in comparison with care as usual. The MyREMEDY study takes place in four countries: The Netherlands, United Kingdom, Spain, and Germany.

Detailed description: Rationale: Type 1 diabetes is a disease that asks constant attention, self-care activities and responsibility from the diagnosed person for the duration of their entire life. Because of this constant burden, many people with type 1 diabetes experience mental health problems such as fatigue, excessive worrying about their blood glucose (especially about dangerously low blood glucose), or eating problems. However, most people with type 1 diabetes who experience such symptoms do not receive professional help. This can have multiple reasons. Oftentimes, the problems are not severe enough to be classified as a disorder. Some people also prefer to work on the problems on their own, at their own pace. For people who experience mental health problems around their diabetes and to support them individually with as little barriers as possible, MyDiaMate was developed.

Objective: To investigate the effectiveness of MyDiaMate in reducing mental health problems in adults with type 1 diabetes who experience distress related to their disease across four countries (NL, DE, UK, ES).

Study design and procedure: Multi-national randomised-controlled trial (intervention : wait-list control group, randomised 2:1 per country).

After screening has confirmed study participation, participants will:

1. Complete the baseline assessment and be randomisation afterwards
2. Use MyDiaMate for 3 months in case of intervention group membership, or get care as usual in case of waitlist control group membership
3. At 3 months, all participants fill in the first follow-up assessment. Additionally, intervention group members will be asked about their satisfaction with and opinion on MyDiaMate (questionnaire and interviews).
4. All participants then receive access to MyDiaMate for the remaining 3 months of the study.
5. At 6 months, all participants complete the second follow-up assessment. Afterwards, the study ends for all participants and access to MyDiaMate is revoked.

Study population: Adults with type 1 diabetes who have been diagnosed more than 6 months ago and who experience distress in relation to their type 1 diabetes.

Intervention: The intervention group receives access to the online self-help programme MyDiaMate for 6 months. MyDiaMate is focused on mental health in type 1 diabetes. It includes psychoeducation and teaches coping strategies that are based on cognitive-behavioural therapy concepts. Moreover, videos in which people with type 1 diabetes talk about their experiences in coping with the disease are embedded in MyDiaMate. MyDiaMate users can also choose to make use of diaries and a module that helps with setting realistic goals. MyDiaMate can be accessed via a private mobile phone, tablet, or laptop/computer whenever wished. Because MyDiaMate is self-help, there is no schedule in when/how much participants should access MyDiaMate. Participants can make use of MyDiaMate as much as they want to, in a way that suits them best personally. Members in the waitlist control group receive access to MyDiaMate after 3 months, for 3 months, if so wished. They too can make use of MyDiaMate in a way that fits their personal time and needs best.

Main study parameters/endpoints: The main study outcome is change in diabetes distress in the intervention group between the baseline and the 3 months assessment. Secondary study outcomes are changes in emotional well-being, psychological self-efficacy in relation to diabetes, social engagement, and fatigue between the baseline and the 3 months assessment in participants from the intervention group. Moreover, in line with the secondary objective, the investigators will make use of MyDiaMate log data such as time spent in MyDiaMate and frequency of use in participants of the intervention group across the first 3 months and investigate in relation to the main and secondary outcomes as well as descriptive data such as age or gender, for which subgroup of MyDiaMate users the application programme is most effective.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks related to use of MyDiaMate. The burden of study participation is low, as participants are not instructed to use MyDiaMate in a certain way/intensity and filling in the non-invasive study questionnaires takes around 2 hr in total and is spread across 6 months. Both the intervention and control group have access to MyDiaMate during study participation (for 6 months in case of intervention group membership, for 3 months after 3 months in case of wait-list control group membership). Study participants benefit from study participation because they receive access to MyDiaMate, which may possibly help them with improving the diabetes-related mental health and teaches a variety of type 1 diabetes specific coping strategies, all of which is based on well-researched concepts of psychoeducation and cognitive behavioural therapy.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old at signing the informed consent form
* Type 1 diabetes diagnosis at least 6 months ago
* Having access to the internet and a smartphone/tablet/laptop'/computer for the entire time of study participation
* Experiencing diabetes distress (checked during a phone call between research assistant and participant. The condition is met if the participant has an average score of ≥2 on the 2-item Diabetes Distress Scale (DDS-2), representing clinically meaningful diabetes distress)

Exclusion Criteria:

* Having been diagnosed with a psychiatric disorder in the past 6 months for which the person is under psychological/psychiatric treatment
* Suicidality
* Having started a treatment with psychotropic medication in the past 3 months
* Illiteracy
* Experience of cognitive problems that hamper using MyDiaMate or vision/auditory problems that are hindering in daily life
* Prior use of MyDiaMate (only applicable to participants in the Netherlands)

Primary outcomes:
measure: Diabetes Distress
timeFrame: Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).
Secondary outcomes:
measure: Emotional well-being
timeFrame: Emotional well-being will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
measure: Psychological self-efficacy in relation to diabetes
timeFrame: Psychological self-efficacy in relation to diabetes will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).
measure: Social Engagement
timeFrame: Social Engagement will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up)
measure: Fatigue
timeFrame: Fatigue will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up)
measure: HbA1c
timeFrame: Glycaemic control measures, in this case Haemoglobine A1c, will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up)
measure: Time in/above/below range
timeFrame: Glycaemic control measures, in this case time in/above/below range, will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up)
measure: Events of ketoacidosis/severe hypoglycaemia
timeFrame: Glycaemic control measures, in this case frequency of events of ketoacidosis and severe hypoglycaemia, will be self-reported at 0 months (baseline), 3 months (intervention effect), and 6 months (follow-up)
Other outcomes:
measure: MyDiaMate usage data
timeFrame: 3 months
Locations:
city: Bad Mergentheim
country: Germany
facility: Forschungsinstitut Diabetes-Akademie Bad Mergentheim
state: Baden-Württemberg
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Málaga
country: Spain
facility: Universidad de Málaga
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Maartje de Wit, Dr.
role: PRINCIPAL_INVESTIGATOR
References: