MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY): A Multi-National Randomised-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 625
- 试验地点
- 7
- 主要终点
- Diabetes Distress
研究概览
简要总结
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.
详细描述
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:
- Complete the baseline assessment and be randomisation afterwards
- Use MyDiaMate for 3 months in case of intervention group membership, or get care as usual in case of waitlist control group membership
- 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).
- All participants then receive access to MyDiaMate for the remaining 3 months of the study.
- At 6 months, all participants complete the second follow-up assessment. Afterwards, the study ends for all participants and access to MyDiaMate is revoked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Intervention
2/3 of participants will be randomised into this arm. They will receive access to MyDiaMate in the language of their participation country for 6 months.
干预措施: MyDiaMate (Behavioral)
Care As Usual
1/3 of participants will be randomised into this arm. They will receive Care As Usual, so no intervention, for 3 months. After 3 months, they receive access to MyDiaMate, if so wished.
结局指标
主要结局
Diabetes Distress
时间窗: Diabetes Distress will be assessed at 0 months (baseline), 3 months (intervention effects), and after 6 months (follow-up).
Diabetes Distress will be assessed through the 20-item Problem Areas In Diabetes questionnaire (=PAID-20). The Problem Areas In Diabetes questionnaire measures diabetes distress on a 5-point Likert scale ranging from 1 (Not a problem) to 5 (Serious Problem). A higher score represents higher diabetes distress.
次要结局
- Fatigue(Fatigue will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up))
- Time in/above/below range(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))
- Events of ketoacidosis/severe hypoglycaemia(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))
- Social Engagement(Social Engagement will be measured at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up))
- HbA1c(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))
- Emotional well-being(Emotional well-being will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).)
- Psychological self-efficacy in relation to diabetes(Psychological self-efficacy in relation to diabetes will be assessed at 0 months (baseline), 3 months (intervention effects), and 6 months (follow-up).)
研究者
Maartje de Wit
Principal Investigator
Amsterdam UMC, location VUmc