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

Part of paid clinical trials in Chinle, Arizona.

Sponsor
Brigham and Women's Hospital
Study ID
NCT03326206
Status
Completed

Conditions

  • Chronic Disease
  • Diabetes Mellitus
  • Hypertension
  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Nov 1, 2013
Status verified
May 2026
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
28,813 participants (actual)

Arms

  • Arm: COPE participants
    Individuals living with diabetes seen at a study site who were enrolled in the COPE programmatic intervention during the study period. Participation in COPE consists of receiving home visits by a Navajo Community Health Representative (CHR) once or twice a month for a period of at least 12 months. CHRs use structured patient coaching materials to support behavior change. CHRs also check vital signs, monitor blood glucose levels through finger sticks, and facilitate access to appointments and medical refills. CHRs communicate regularly with providers through electronic health record documentation and case management rounds. In-person or telephone communication is be used to address acute issues that may arise.
  • Arm: Non-COPE participants
    Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics.

Primary Outcome Measure

Change in Percentage of Glycated Hemoglobin (HbA1c) [ Time Frame: 24 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Chinle Comprehensive Health Care FacilityChinleArizona86503-
Tsehootsooi Medical CenterFort DefianceArizona86504-
Kayenta Health CenterKayentaArizona86033-
Crownpoint Health Center FacilityCrownpointNew Mexico87313-
Gallup Indian Medical CenterGallupNew Mexico87301-
Northern Navajo Medical CenterShiprockNew Mexico87420-

Find similar trials in Chinle, AZ

By condition
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By specialty
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By research site
Chinle Comprehensive Health Care Facility· Chinle, AZTsehootsooi Medical Center· Fort Defiance, AZKayenta Health Center· Kayenta, AZCrownpoint Health Center Facility· Crownpoint, NMGallup Indian Medical Center· Gallup, NMNorthern Navajo Medical Center· Shiprock, NM

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