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NCT02175732 · ClinicalTrials.gov registry record · NA
Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 301
- Enrollment target
NCT02175732 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 301 participants.
The verdict
NCT02175732, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 301 participants
- Enrollment target
Study Summary
Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that arise through living with and managing diabetes. High DD is characterized by feeling frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a negative impact on disease management and glycemic control; poor glycemic control can also have a negative effect on DD. Few interventions have been assessed that directly target DD or mood in adults with Type 1 diabetes. In this study the investigators will compare two active, evidence-based behavioral interventions to reduce high DD and improve glycemic control and disease management: 1. A Type 1 diabetes education protocol ('KnowIt') that brings together new advances in diabetes education and behavioral management. 2. A DD-reduction protocol ('OnTrack') that helps identify and address the personal stresses and strains of having diabetes. Participants in both arms will attend a single, day-long workshop, four hour-long web group meetings and four personal phone calls with the group facilitator during the intervention period. Assessments will be carried out at baseline and at three and nine months. Hypothesis 1: OnTrack will be superior to KnowIt in the primary and secondary outcomes at follow-up. Hypothesis 2: Changes in self-efficacy and fear of hypoglycemia over time will mediate the difference between the two study arms and primary outcome. Hypothesis 3: The differences between the two study arms and changes in the primary outcomes will be qualified by patient characteristics such as age, length of diagnosis, higher baseline distress or HbA1c.
Interventions
- BEHAVIORAL 'KnowIt'
- BEHAVIORAL 'OnTrack'
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2014-09 |
| Est. Completion | 2018-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02175732
The ClinicalTrials.gov registry entry for NCT02175732 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 'KnowIt' is the first listed.
NCT02175732 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02175732 about?
NCT02175732 is a clinical study titled "Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes". Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that arise through living with and managing diabetes. High DD is characterized by feeling frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a negative impact on disease managem...
What is the current status of trial NCT02175732?
This trial is currently completed. It is a NA study. The enrollment target is 301 participants. The study started on 2014-09. Estimated completion is 2018-12.
What interventions are being tested in trial NCT02175732?
The interventions under investigation include: 'KnowIt' (BEHAVIORAL), 'OnTrack' (BEHAVIORAL).
Who is sponsoring clinical trial NCT02175732?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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