Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448338
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-03
Brief Title:
UK MyREMEDY Clinical Trial
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
MyDiaMate for Remission of Elevated Diabetes Distress in Type 1 Diabetes the UK MyREMEDY Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
UK-MyREMEDY
Brief Summary:
The UK MyREMEDY study investigates whether MyDiaMate an online self-help program can effectively improve the mental health of adults with type 1 diabetes compared to those receiving care as usual
Detailed Description:
The psychological burden of living with and self-managing type 1 diabetes is well-recognized Nevertheless access to mental health services for people with type 1 diabetes is generally limited even in well-resourced settings Digital solutions or e-mental health a rapidly expanding field offer a complement to existing services However while many apps target glucose and lifestyle particularly for type 2 diabetes few digital tools focusing on healthy coping and mental health for type 1 diabetes exist MyDiaMate was developed to alleviate this deficiency and its effectiveness in terms of reduction of diabetes distress among people with type 1 diabetes will be evaluated by this study UK MyREMEDY is conducted in conjunction with a wider evaluation of MyDiaMate in the Netherlands Spain and Germany
Previously an observational pilot study in the Netherlands demonstrated the acceptability and feasibility of MyDiaMate and additionally suggested positive effects on mental health Nevertheless MyDiaMate has not been evaluated in a UK setting The principal research objective of this study is to determine the effectiveness of MyDiaMate over time in adults with type 1 diabetes This will be assessed in terms of improvement of mental health with diabetes distress as primary outcome relative to care as usual
The effectiveness of MyDiaMate will be tested in a two-arm parallel randomized controlled trial This study design will allow researchers to assess differences in mental health diabetes self-care and glycemic control in participants using MyDiaMate versus participants undergoing care as usual randomized 21
The study population will consist of adults with type 1 diabetes in the UK who were diagnosed at least 6 months prior and who experience distress related to their diabetes After participants are screened for eligibility and confirm their participation in the study they will complete a baseline assessment and be randomized to the intervention or control group For their first 3 months of participation the control group will receive care as usual while the participants in the experimental group will be given access to MyDiaMate via an online link After 3 months all participants irrespective of randomized groups will be given access to MyDiaMate Access to MyDiaMate will end after 6 months of study participation All participants will additionally be asked to complete several online self-reported measures of primary and secondary outcomes at baseline three months and six months
MyDiaMate offers online modules centered around common sources of diabetes distress such as the disruptive impact of stress on blood glucose fear of hypoglycemia worries about complications disordered eating and stressful social interactions as well as low wellbeing and fatigue Grounded in principles of cognitive behavioral therapy MyDiaMate includes psycho-education and coping strategies presented in a variety of formats including written content videos diaries and other activities The participants can access the program on their personal device as often as wished for the duration of the study with no prescribed frequency of use
Participation in this study is low risk and participants have the opportunity to engage with MyDiaMate as much as desired Completion of the study questionnaires is estimated to take 2 hours spread across the participation period 6 months The participants may benefit from use of MyDiaMate and experience improved mental health and reduced diabetes distress
After the study has concluded in the UK the investigators will share the anonymized data with the research team of the international MyREMEDY clinical trial Subsequent pooled analyses will contribute to complete evaluation of MyDiaMate and the further support of the mental wellbeing of people with type 1 diabetes
Previously an observational pilot study in the Netherlands demonstrated the acceptability and feasibility of MyDiaMate and additionally suggested positive effects on mental health Nevertheless MyDiaMate has not been evaluated in a UK setting The principal research objective of this study is to determine the effectiveness of MyDiaMate over time in adults with type 1 diabetes This will be assessed in terms of improvement of mental health with diabetes distress as primary outcome relative to care as usual
The effectiveness of MyDiaMate will be tested in a two-arm parallel randomized controlled trial This study design will allow researchers to assess differences in mental health diabetes self-care and glycemic control in participants using MyDiaMate versus participants undergoing care as usual randomized 21
The study population will consist of adults with type 1 diabetes in the UK who were diagnosed at least 6 months prior and who experience distress related to their diabetes After participants are screened for eligibility and confirm their participation in the study they will complete a baseline assessment and be randomized to the intervention or control group For their first 3 months of participation the control group will receive care as usual while the participants in the experimental group will be given access to MyDiaMate via an online link After 3 months all participants irrespective of randomized groups will be given access to MyDiaMate Access to MyDiaMate will end after 6 months of study participation All participants will additionally be asked to complete several online self-reported measures of primary and secondary outcomes at baseline three months and six months
MyDiaMate offers online modules centered around common sources of diabetes distress such as the disruptive impact of stress on blood glucose fear of hypoglycemia worries about complications disordered eating and stressful social interactions as well as low wellbeing and fatigue Grounded in principles of cognitive behavioral therapy MyDiaMate includes psycho-education and coping strategies presented in a variety of formats including written content videos diaries and other activities The participants can access the program on their personal device as often as wished for the duration of the study with no prescribed frequency of use
Participation in this study is low risk and participants have the opportunity to engage with MyDiaMate as much as desired Completion of the study questionnaires is estimated to take 2 hours spread across the participation period 6 months The participants may benefit from use of MyDiaMate and experience improved mental health and reduced diabetes distress
After the study has concluded in the UK the investigators will share the anonymized data with the research team of the international MyREMEDY clinical trial Subsequent pooled analyses will contribute to complete evaluation of MyDiaMate and the further support of the mental wellbeing of people with type 1 diabetes
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RMS360 | OTHER_GRANT | JDRF | None |