Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program

Completed

Conditions studied: Diabetes Mellitus, Metabolic Syndrome, Hypertension, Chronic Disease

In brief

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 health facilities. Cases include individuals participating in the COPE intervention; controls are non-COPE participants identified within the same hospital and matched based on similar baseline characteristics. Study findings will improve clinical and patient-decision making and the health of marginalized AI/ANs by informing policies to promote CHR interventions in rural and underserved communities.

Key facts

Study ID

NCT03326206

Run by

Brigham and Women's Hospital

People needed

28813

Starts

2013-11-01

Expected to finish

2015-12-31

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetes
• Treated at a participating IHS facility corresponding to their home residence

You may not qualify if…

• Not seen in one of the six participating clinical sites

Where it is running

• Chinle Comprehensive Health Care Facility — Chinle, Arizona, United States
• Tsehootsooi Medical Center — Fort Defiance, Arizona, United States
• Kayenta Health Center — Kayenta, Arizona, United States
• Crownpoint Health Center Facility — Crownpoint, New Mexico, United States
• Gallup Indian Medical Center — Gallup, New Mexico, United States
• Northern Navajo Medical Center — Shiprock, New Mexico, United States

Full record on ClinicalTrials.gov

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