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Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
NCT03326206 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28,813 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 929 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Hypertension appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03326206 reports 6 study locations spanning 2 distinct geographic areas — top geographies include Arizona, New Mexico. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT03326206?
This trial is sponsored by Brigham and Women's Hospital, which has 929 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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