Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06308549
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-02-15
Brief Title:
MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes MyREMEDY
Sponsor:
Maartje de Wit
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes MyREMEDY A Multi-National Randomised-Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MyREMEDY
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 21 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 laptopcomputer whenever wished Because MyDiaMate is self-help there is no schedule in whenhow 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 parametersendpoints 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 wayintensity 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
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 21 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 laptopcomputer whenever wished Because MyDiaMate is self-help there is no schedule in whenhow 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 parametersendpoints 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 wayintensity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None