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NCT01876485 · ClinicalTrials.gov registry record · NA
Point-of-care Health Literacy and Activation Information to Improve Diabetes Care
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 280
- Enrollment target
NCT01876485: Completed NA study, sponsored by VA Office of Research and Development.
NCT01876485 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 280 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01876485, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 280 participants
- Enrollment target
Study Summary
This hybrid effectiveness/implementation trial will be conducted in two phases over four years. In Phase 1, the investigators will evaluate the process of implementing a collaborative, diabetes goal-setting intervention (Empowering Patients in Chronic Care \[EPIC\]) personalized to self-reported patient activation and functional health literacy (FHL) levels into routine primary care practices. In Phase 2, the investigators will conduct a randomized, clinical trial to compare the effectiveness of EPIC to enhanced usual care (EUC). In Phase 2, the investigators will conduct a randomized clinical trial enrolling 284 Veterans with poorly controlled diabetes defined by average hemoglobin A1c over the last six months of \>= 8% to receive EPIC or enhanced usual care (EUC). Consented subjects will be allocated evenly between EPIC and EUC. EPIC consists of six 1-hour group sessions focusing on 1) Your Health, Your Values, 2) Diabetes ABCs, 3) Setting Goals and Making Action Plans, 4) Communication with Your Health Care Provider, 5) Staying Committed to Your Goals, and 6) Reviewing and Planning for the Future. After each group session, a one-on-one session between a designated PACT member and patient participants will focus on collaborative goal-setting. Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility. Study measurements using self-reported questionnaires and blood tests to assess blood sugar control will be obtained at baseline, post-intervention, and post-six month maintenance period.
Interventions
- BEHAVIORAL Enhanced Usual Care (EUC)
- BEHAVIORAL Empowering Patients in Chronic Care (EPIC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2015-07-13 |
| Est. Completion | 2018-02-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01876485
The ClinicalTrials.gov registry entry for NCT01876485 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enhanced Usual Care (EUC) is the first listed.
NCT01876485 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01876485 about?
NCT01876485 is a clinical study titled "Point-of-care Health Literacy and Activation Information to Improve Diabetes Care". This hybrid effectiveness/implementation trial will be conducted in two phases over four years. In Phase 1, the investigators will evaluate the process of implementing a collaborative, diabetes goal-setting intervention (Empowering Patients in Chronic Care \[EPIC\]) personalized to self-reported pat...
What is the current status of trial NCT01876485?
This trial is currently completed. It is a NA study. The enrollment target is 280 participants. The study started on 2015-07-13. Estimated completion is 2018-02-09.
What interventions are being tested in trial NCT01876485?
The interventions under investigation include: Enhanced Usual Care (EUC) (BEHAVIORAL), Empowering Patients in Chronic Care (EPIC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01876485?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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