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NCT03845465 · ClinicalTrials.gov registry record · NA
Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes
A NA study of Type 1 Diabetes Mellitus, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 2
- Study locations
NCT03845465: Completed NA study of Type 1 Diabetes Mellitus, sponsored by Vanderbilt University Medical Center.
NCT03845465 is a NA study of Type 1 Diabetes Mellitus that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 400 participants, above the 169-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (137% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03845465, a NA study of Type 1 Diabetes Mellitus, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 2
- Study locations
Study Summary
The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents experience diabetes distress related to the daily demands of diabetes care, which can cause problems with diabetes management and glycemic control. The proposed study will conduct a multisite, randomized trial to test the effects of a positive psychology intervention aimed at treating diabetes distress and improving glycemic outcomes. The potential benefits include helping adolescents achieve better glycemic control, improved self-management, and psychosocial outcomes
Primary Outcome
Hemoglobin A1c measures the amount of glucose attached to hemoglobin. It is assessed as part of regular diabetes clinic visits. The target is \<7.0%.
Conditions Studied
Interventions
- BEHAVIORAL Education
- BEHAVIORAL Positive Affect + Education
Study Locations (2)
District of Columbia
- Children's National - Washington D.C.
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2023-09-07 |
| Phase | NA |
What the finished NCT03845465 record still lists
NCT03845465 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (137% higher).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Education is the first listed.
NCT03845465 reports a single indexed study location in District of Columbia, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03845465 about?
NCT03845465 is a clinical study titled "Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes". The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents experience diabetes distress related to the daily demands of diabetes care, which can cause problems with diabetes management and glycemic control. The proposed study will conduct a multisite, randomized trial t...
What is the current status of trial NCT03845465?
This trial is currently completed. It is a NA study. The enrollment target is 400 participants. The study started on 2019-12-17. Estimated completion is 2023-09-07.
What conditions does trial NCT03845465 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03845465?
The interventions under investigation include: Education (BEHAVIORAL), Positive Affect + Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT03845465?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03845465 being conducted?
This trial has 2 study locations across District of Columbia, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03845465's enrollment target sits among peer trials
400 10th of 112 higher than 102 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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