Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405386
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-06
Brief Title:
Pilot of Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Fusing Rapid-cycle Testing and Adaptive Trial Designs A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
ChargeUp
Brief Summary:
This study is designed to test the feasibility and acceptability of behavioral approaches to reduce diabetes distress the expected burdens concerns fears and threats that arise from the challenges of living with diabetes in adults with type 1 diabetes This is a pilot study which will enroll a small group of participants to enroll and give feedback on their experience
At the study baseline participants will be randomized to take part in one of two virtual group-based interventions the Primary intervention utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress After the intervention participants will attend focus groups and fill out anonymous qualitative surveys to give feedback on their experience Results of the pilot will inform and improve an upcoming research study of the same design
At the study baseline participants will be randomized to take part in one of two virtual group-based interventions the Primary intervention utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress After the intervention participants will attend focus groups and fill out anonymous qualitative surveys to give feedback on their experience Results of the pilot will inform and improve an upcoming research study of the same design
Detailed Description:
The study will test the feasibility and acceptability of two behavioral-based interventions to reduce diabetes distress DD The investigators will enroll one cohort N15 adults 30 years and older with type 1 diabetes T1D and elevated DD from a single clinical site to participate in a 5-week intervention All interventions and assessments will be delivered in a pragmatic and entirely virtual format
The investigators will compare two evidence-based virtual group interventions to reduce DD in adults with T1D The study includes a randomization to one of two 5-week Primary Interventions ReCharge an Acceptance and Commitment Therapy ACT-focused approach that will help to reduce the emotional burden of diabetes management or TakeCharge a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes
After the 5-week intervention period participants will provide final outcome data and feedback on their experience using surveys and focus groups Quantitative and quantitative results will be used to improve the intervention prior to rollout of a longer-term trial of the same design Long-term data will be collected at 12-weeks post enrollment
The investigators will compare two evidence-based virtual group interventions to reduce DD in adults with T1D The study includes a randomization to one of two 5-week Primary Interventions ReCharge an Acceptance and Commitment Therapy ACT-focused approach that will help to reduce the emotional burden of diabetes management or TakeCharge a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes
After the 5-week intervention period participants will provide final outcome data and feedback on their experience using surveys and focus groups Quantitative and quantitative results will be used to improve the intervention prior to rollout of a longer-term trial of the same design Long-term data will be collected at 12-weeks post enrollment
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 |
|---|---|---|---|
| 12-22-ACE-18 | OTHER_GRANT | American Diabetes Association | None |