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NCT04461405 · ClinicalTrials.gov registry record · NA
INTEGRATE-D: A Pilot Test to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes
A NA study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- NA
- Development phase
- 294
- Enrollment target
NCT04461405 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 294 participants.
The verdict
NCT04461405, a NA study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- NA
- Development phase
- 294 participants
- Enrollment target
Study Summary
In 2016, the American Diabetes Association (ADA) published its first-ever recommendations for integrating medical and psychosocial care for patients with Type II Diabetes Mellitus (DMII) and common mental and behavioral health (MH/BH) problems. In the United States, 30 million people live with DMII, and the majority receive care in primary care settings. By implementing the ADA recommendations, primary care practices will help patients better manage their MH/BH needs, meet recommended goals for DMII management, and reduce the risk of adverse outcomes. Making these recommendations a routine part of practice is a major change, and it is critical to understand how best to implement the ADA recommendations and test its effectiveness in the real world. The pilot study builds on a series of prior studies to refine and pilot test a package of implementation strategies - called INTEGRATE-D - to support practices in implementing the ADA recommendations for integrated DMII care. INTEGRATE-D combines the following evidence-based implementation strategies: (1) electronic health record (EHR)-based support - to help align EHR use with ADA recommendations and enable screening for depression, anxiety, diabetes distress, cognitive impairment, and self-management, and support identifying and tracking progress on patient treatments and goals; (2) Audit and feedback - which involves assisting practices in accessing clinically relevant, actionable data reports to inform measurement and identification of care gaps in DMII and behavioral health care; (3) Skill-building resources - including training on ADA-recommended care; and (4) Facilitation - to help implement the above strategies and tailor the intervention so that practice work on the subset of areas where practices are ready to change to align care with ADA recommendations. The study aims are Aim 1: Refine the INTEGRATE-D intervention by incorporating the preferences of stakeholders. In partnership with patients, primary care key s
Interventions
- BEHAVIORAL INTEGRATE-D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2020-03-01 |
| Est. Completion | 2022-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04461405
The ClinicalTrials.gov registry entry for NCT04461405 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 294 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which INTEGRATE-D is the first listed.
NCT04461405 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04461405 about?
NCT04461405 is a clinical study titled "INTEGRATE-D: A Pilot Test to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes". In 2016, the American Diabetes Association (ADA) published its first-ever recommendations for integrating medical and psychosocial care for patients with Type II Diabetes Mellitus (DMII) and common mental and behavioral health (MH/BH) problems. In the United States, 30 million people live with DMII,...
What is the current status of trial NCT04461405?
This trial is currently completed. It is a NA study. The enrollment target is 294 participants. The study started on 2020-03-01. Estimated completion is 2022-07-01.
What interventions are being tested in trial NCT04461405?
The interventions under investigation include: INTEGRATE-D (BEHAVIORAL).
Who is sponsoring clinical trial NCT04461405?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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