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NCT03617146 · ClinicalTrials.gov registry record · NA
Coaching and Education for Diabetes Distress
A NA study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT03617146: Clinical Trial NA study, sponsored by Baylor College of Medicine.
NCT03617146 is a NA study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03617146, a NA study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
Diabetes distress (DD) is a negative emotional reaction to a diagnosis of diabetes and concerns about the burden of managing diabetes, the risk of complications, and inadequate support system. DD is common among people with diabetes and is strongly associated with poor diabetes self-care and poor diabetes control. Reducing DD should thus be an important component of diabetes management. In line with the growing evidence, the American Diabetes Association now recommends that providers "routinely monitor people with diabetes for diabetes distress, particularly when treatment targets are not met". Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD. This study seeks to assess whether HC effectively reduces DD among primary care patients with diabetes, and whether HC is more effective than an educational program targeting DD. The investigators hypothesize that over a 6-month period, patients with poorly controlled diabetes and DD who enroll in and complete at least five HC sessions will achieve higher and clinically significant reductions in DD and HbA1c, and greater compliance with diabetes self-care recommendations than those who receive only an educational program targeting DD as part of usual diabetes care. The two-arm randomized controlled trial for patients with poorly-controlled diabetes is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive eight HC sessions over a five-month period. The primary outcome measure is reduction in DD over a six month period. Additional outcome measures includ
Primary Outcome
Change in diabetes distress score as measured by the diabetes distress scale (DDS). DDS scores range from 1 to 6, with scores that are less than 2.0 being indicative of little or no distress. Hence scores of 2.0 and above are significant and higher values are indicative of worse outcome.
Interventions
- BEHAVIORAL Health coaching
- OTHER Diabetes Distress-specific Education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2020-09-17 |
| Phase | NA |
Why NCT03617146 stopped before completion
NCT03617146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Health coaching is the first listed.
NCT03617146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03617146 about?
NCT03617146 is a clinical study titled "Coaching and Education for Diabetes Distress". Diabetes distress (DD) is a negative emotional reaction to a diagnosis of diabetes and concerns about the burden of managing diabetes, the risk of complications, and inadequate support system. DD is common among people with diabetes and is strongly associated with poor diabetes self-care and poor di...
What is the current status of trial NCT03617146?
This trial is currently terminated. It is a NA study. The enrollment target is 19 participants. The study started on 2018-06-15. Estimated completion is 2020-09-17.
What interventions are being tested in trial NCT03617146?
The interventions under investigation include: Health coaching (BEHAVIORAL), Diabetes Distress-specific Education (OTHER).
Who is sponsoring clinical trial NCT03617146?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03617146's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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