N/A
N=3,053
Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
Diabetes Mellitus · Metabolic Syndrome · Hypertension · Chronic Disease
Bottom Line
View on ClinicalTrials.gov: NCT03326206 ↗Enrolled (actual)
3,053
Serious AEs
0.2%
Results posted
Dec 2025
Primary outcome: Primary: Change in Percentage of Glycated Hemoglobin (HbA1c) — -0.49; 0.13 percent — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of Glycated Hemoglobin (HbA1c) |
-0.49; 0.13 | <0.0001 sig |
| SECONDARY Change in Systolic Blood Pressure |
1.43; 0.28 | 0.004 sig |
| SECONDARY Change in Low-density Lipoprotein |
-8.04; -3.21 | 0.02 sig |
| SECONDARY Change in Body Mass Index |
-0.25; -0.26 | 0.93 |
| SECONDARY Change in Primary Outpatient Services |
1.0750; 0.9224 | 0.0091 sig |
| SECONDARY Change in Specialty Outpatient Services |
0.8856; 0.6838 | 0.0003 sig |
| SECONDARY Change in Emergency Services |
0.2755; 0.2559 | 0.4296 |
| SECONDARY Change in Counseling / Behavioral Services |
0.2590; 0.1432 | <0.0001 sig |
| SECONDARY Change in Laboratory Services |
0.3510; 0.2798 | 0.0431 sig |
| SECONDARY Change in Radiology Services |
0.0304; 0.0220 | 0.0516 |
| SECONDARY Change in Pharmacy Services |
0.5477; 0.5146 | 0.3582 |
| SECONDARY Change in Inpatient Services |
0.1869; 0.1592 | 0.2461 |
| SECONDARY Change in Dental Encounters |
0.1119; 0.1422 | 0.0613 |
| SECONDARY Change in Community Encounters |
0.1160; 0.0189 | <0.0001 sig |
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 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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of diabetes
- Treated at a participating IHS facility corresponding to their home residence
Exclusion Criteria
- Not seen in one of the six participating clinical sites
Data sourced from ClinicalTrials.gov (NCT03326206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.