Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275412
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-02-08
Brief Title:
Family Intervention for Black Teens With Type 1 Diabetes
Sponsor:
Wayne State University
Organization:
Wayne State University
Study Overview
Official Title:
Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-07
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:
3Ms
Brief Summary:
The purpose of this study is to conduct a multicenter randomized effectiveness trial of The 3Ms 20 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes T1D and their primary caregivers The proposed study would develop and test The 3Ms 20 adapted intervention when delivered using a mobile health approach accessed via parents cell phone The intervention will also include new family intervention content videoclips and text messages
Detailed Description:
The proposed study is a multi-center randomized controlled trial RCT examining the efficacy of The 3Ms 20 compared to an educational attention control condition EAC for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes T1D and their primary caregivers A randomized controlled repeated measures design will be used The study will use a sample of 216 Black adolescent-caregiver dyads Participants will be recruited at two sites University of Tennessee Health Sciences Center LeBonheur Childrens Hospital and Childrens National Hospital in Washington DC 108 families will be recruited at each of the two sites Wayne State University WSU will function as the coordinating center for the trial and will be responsible for overseeing the adequacy of all aspects of trial management
Participants will be randomly assigned in a 11 ratio to receive The 3Ms 20 plus standard medical care or EAC plus standard medical care In the 3Ms 20 condition primary caregivers will receive a brief 10-20 minute 3 session computer-delivered intervention via their mobile device The intervention is designed to increase parental daily supervision of adolescent diabetes management In the control condition primary caregivers will also receive 3 brief computer-delivered sessions where the content is information and facts about type 1 diabetes The intervention content will be available to the primary caregiver during a six month window and can be completed at their convenience
Data collection occurs in the families home at baseline T1 three months post-baseline corresponding with the midpoint of the intervention window T2 six months post- baseline corresponding with the end of the intervention window T3 and 12 months post-baseline T4 Data completion can be completed via the Internet should families live outside a reasonable driving distance from the recruitment site Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management parental supervision of diabetes management family relationships and youth quality of life Blood will also be collected to measure HbA1c mean blood glucose level Medical record data will also be collected
The data analyses will be intent-to-treat meaning that all randomized participants are included regardless of the intervention dose received Trial data will analyzed using the linear mixed effect model LME for repeated measures
Participants will be randomly assigned in a 11 ratio to receive The 3Ms 20 plus standard medical care or EAC plus standard medical care In the 3Ms 20 condition primary caregivers will receive a brief 10-20 minute 3 session computer-delivered intervention via their mobile device The intervention is designed to increase parental daily supervision of adolescent diabetes management In the control condition primary caregivers will also receive 3 brief computer-delivered sessions where the content is information and facts about type 1 diabetes The intervention content will be available to the primary caregiver during a six month window and can be completed at their convenience
Data collection occurs in the families home at baseline T1 three months post-baseline corresponding with the midpoint of the intervention window T2 six months post- baseline corresponding with the end of the intervention window T3 and 12 months post-baseline T4 Data completion can be completed via the Internet should families live outside a reasonable driving distance from the recruitment site Data collection is completed by the adolescent and caregiver on a tablet computer and includes questionnaires to assess adolescent diabetes management parental supervision of diabetes management family relationships and youth quality of life Blood will also be collected to measure HbA1c mean blood glucose level Medical record data will also be collected
The data analyses will be intent-to-treat meaning that all randomized participants are included regardless of the intervention dose received Trial data will analyzed using the linear mixed effect model LME for repeated measures
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 |
|---|---|---|---|
| 5R01MD018583-02 | NIH | None | httpsreporternihgovquickSearch5R01MD018583-02 |