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NCT01892592 · ClinicalTrials.gov registry record · NA
Discovering Healthcare Innovations to Address Disparities in Stroke (DIADS)
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 1,761
- Enrollment target
NCT01892592 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 1,761 participants.
The verdict
NCT01892592, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,761 participants
- Enrollment target
Study Summary
The goal of this pragmatic study is to improve hypertension (HTN) control rate in blacks and to reduce racial disparity in HTN control. To accomplish this, the investigators propose to perform a cluster randomized controlled trial at the primary care provider (PCP) level and including 191 PCPs within KPNC East Bay Service Area with more than 45,000 patients in the HTN registry of which approximately 15,000 are black. The investigators will randomize all PCP patient panels to a three-arm trial to receiving either 1) usual care; or 2) culturally tailored diet and lifestyle coaching; or 3) an intensified BP management protocol with pharmacotherapy. The "Shake, Rattle and Roll" trial is named for: 1) "shake" the salt habit; 2) "rattle" the intensity of current BP management; and 3) design the interventions with the goal of being able to adapt and "roll" them out to community clinics outside of a managed care system. Primary research question: whether a primary prevention intervention of either diet and lifestyle coaching or an intensive pharmacotherapy protocol is more effective than usual care in improving rates of HTN control in blacks and thereby reducing disparities between black and white. Primary aim: By implementing either intervention, the investigators will reduce the disparity in hypertension control rates between blacks and whites by 4% at 1 year post-study enrollment. Hypothesis: Among blacks with HTN, a diet/lifestyle coaching intervention or an intensified BP management protocol will result in an increase in HTN control rate compared to usual care. Primary outcome: the proportion of patients with sustained BP control at 1 year post-study enrollment.
Interventions
- BEHAVIORAL Diet and Lifestyle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,761 participants |
| Start Date | 2013-06 |
| Est. Completion | 2018-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01892592
The ClinicalTrials.gov registry entry for NCT01892592 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,761 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Diet and Lifestyle is the first listed.
NCT01892592 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01892592 about?
NCT01892592 is a clinical study titled "Discovering Healthcare Innovations to Address Disparities in Stroke (DIADS)". The goal of this pragmatic study is to improve hypertension (HTN) control rate in blacks and to reduce racial disparity in HTN control. To accomplish this, the investigators propose to perform a cluster randomized controlled trial at the primary care provider (PCP) level and including 191 PCPs withi...
What is the current status of trial NCT01892592?
This trial is currently completed. It is a NA study. The enrollment target is 1,761 participants. The study started on 2013-06. Estimated completion is 2018-06.
What interventions are being tested in trial NCT01892592?
The interventions under investigation include: Diet and Lifestyle (BEHAVIORAL).
Who is sponsoring clinical trial NCT01892592?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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