Mode
Text Size
Log in / Sign up
N/A N=3,053

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

Diabetes Mellitus · Metabolic Syndrome · Hypertension · Chronic Disease

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search