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NCT03326206 · ClinicalTrials.gov registry record
Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
A clinical trial of Hypertension and Diabetes Mellitus, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- 28,813
- Enrollment target
- 6
- Study locations
NCT03326206 is a study of Hypertension and Diabetes Mellitus that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 28,813 participants, above the 3,446-participant average among 470 other Hypertension trials with a reported enrollment target (736% higher). The trial reports 6 study locations across 2 states.
The verdict
NCT03326206, a study of Hypertension and Diabetes Mellitus, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- 28,813 participants
- Enrollment target
- 6
- Study locations
Study Summary
Since 2009, a programmatic community-based strategy (COPE) has been implemented to address health disparities among Navajo individuals living with multiple chronic conditions. COPE (Community Outreach and Patient Empowerment) targets individual, family, and health system-level factors through four activities: 1) coordination between community health representatives (CHRs) and Indian Health Service providers; 2) CHR competency with standardized training; 3) a culturally-sensitive health promotion curriculum for patients and families; and 4) strong CHR supervision. COPE has been implemented throughout Navajo Nation. Enrollment is programmatic; in other words, the decision to enroll a patient in COPE occurs independently of whether the patient is in this study. Participants receive the COPE intervention in the same manner and intensity, whether they are included in this observational study or not. The main goal of this observational research is to understand if COPE improves the lives of participating community members. The Primary Aim is to assess the impact of the COPE Project on changes in HbA1c and other CVD risk factors. Hypothesis: Patients enrolled in the COPE program will experience a reduction in HbA1c compared to the control group. Secondary aims are: 1) To understand if COPE improves patients' own self-reported outcomes. Hypothesis: COPE patients will report better health compared with their own baseline at 12 months. 2) To Identify factors associated with increased effectiveness of the COPE Project at the individual, community, and health system level using a mixed-model approach. 3) To understand diverse stakeholder perspectives on COPE impact and value among CHRs, providers and the health care system. Hypothesis: Compared with baseline, CHRs will report greater empowerment in their work, providers will report greater confidence in CHRs. The observational cohort will be comprised of individuals with diabetes receiving care at one of the participating he
Conditions Studied
Study Locations (6)
Arizona
- Chinle Comprehensive Health Care Facility - Chinle
- Tsehootsooi Medical Center - Fort Defiance
- Kayenta Health Center - Kayenta
New Mexico
- Crownpoint Health Center Facility - Crownpoint
- Gallup Indian Medical Center - Gallup
- Northern Navajo Medical Center - Shiprock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28,813 participants |
| Start Date | 2013-11-01 |
| Est. Completion | 2015-12-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03326206
The ClinicalTrials.gov registry entry for NCT03326206 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 28,813 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 3,446-participant average among 470 other Hypertension trials with a reported enrollment target (736% higher). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Hypertension appearing as the primary indexed condition, and to 0 interventions.
NCT03326206 reports 6 study locations spanning 2 distinct geographic areas - top geographies include Arizona, New Mexico.
Frequently Asked Questions
What is clinical trial NCT03326206 about?
NCT03326206 is a clinical study titled "Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program". Since 2009, a programmatic community-based strategy (COPE) has been implemented to address health disparities among Navajo individuals living with multiple chronic conditions. COPE (Community Outreach and Patient Empowerment) targets individual, family, and health system-level factors through four a...
What is the current status of trial NCT03326206?
This trial is currently completed. The enrollment target is 28,813 participants. The study started on 2013-11-01. Estimated completion is 2015-12-31.
What conditions does trial NCT03326206 study?
This clinical trial studies the following conditions: Hypertension, Diabetes Mellitus, Metabolic Syndrome, Chronic Disease.
Who is sponsoring clinical trial NCT03326206?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03326206 being conducted?
This trial has 6 study locations across Arizona, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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