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

NCT03326206 | Completed Results

• 1 other identifier: AD-1304-6566
• Study Type: observational
• Target: 28,813
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Diabetes Mellitus; Metabolic Syndrome; Hypertension; Chronic Disease

Keywords

Navajo; Community Health Workers; Community Health Representatives; Tribal health systems; American Indian; Rural; Health disparities

Outcome Measures

Primary Outcomes (1)

• Change in Percentage of Glycated Hemoglobin (HbA1c)

  Change in Hemoglobin A1c measured at 24 months, compared with baseline

  24 months

Secondary Outcomes (13)

• Change in Systolic Blood Pressure

  24 months

• Change in Low-density Lipoprotein

  24 months

• Change in Body Mass Index

  24 months

• Change in Primary Outpatient Services

  24 months

• Change in Specialty Outpatient Services

  24 months

Other Outcomes (3)

• Patient-reported Good Health

  12 months

• Patient-reported Sense of Control

  12 months

• Patient-reported Ability to Cope

  12 months

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals receiving care at a Navajo Area Indian Health Service facility, living with diabetes

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Eastern Research Group: collaborator

Study Sites (6)

Chinle Comprehensive Health Care Facility

Chinle, Arizona, 86503, United States

Location

Tsehootsooi Medical Center

Fort Defiance, Arizona, 86504, United States

Location

Kayenta Health Center

Kayenta, Arizona, 86033, United States

Location

Crownpoint Health Center Facility

Crownpoint, New Mexico, 87313, United States

Location

Gallup Indian Medical Center

Gallup, New Mexico, 87301, United States

Location

Northern Navajo Medical Center

Shiprock, New Mexico, 87420, United States

Location

Related Publications (4)

• Franz C, Atwood S, Orav EJ, Curley C, Brown C, Trevisi L, Nelson AK, Begay MG, Shin S. Community-based outreach associated with increased health utilization among Navajo individuals living with diabetes: a matched cohort study. BMC Health Serv Res. 2020 May 25;20(1):460. doi: 10.1186/s12913-020-05231-4.

  PMID: 32450874 DERIVED

• Brown C, Lalla A, Curley C, King C, Muskett O, Salt S, Ray K, Begay MG, Nelson AK, Shin S. Community-clinic linkages: qualitative provider perspectives on partnering with community health representatives in Navajo Nation. BMJ Open. 2020 Feb 12;10(2):e031794. doi: 10.1136/bmjopen-2019-031794.

  PMID: 32054623 DERIVED

• Lalla A, Salt S, Schrier E, Brown C, Curley C, Muskett O, Begay MG, Shirley L, Clark C, Singer J, Shin S, Nelson AK. Qualitative evaluation of a community health representative program on patient experiences in Navajo Nation. BMC Health Serv Res. 2020 Jan 8;20(1):24. doi: 10.1186/s12913-019-4839-x.

  PMID: 31914997 DERIVED

• Trevisi L, Orav JE, Atwood S, Brown C, Curley C, King C, Muskett O, Sehn H, Nelson KA, Begay MG, Shin SS. Integrating community health representatives with health care systems: clinical outcomes among individuals with diabetes in Navajo Nation. Int J Equity Health. 2019 Nov 27;18(1):183. doi: 10.1186/s12939-019-1097-9.

  PMID: 31771603 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Metabolic Syndrome; Hypertension; Chronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is an observational study using routine clinical data for endpoints other than patient-reported outcomes. Therefore, the participant flow and adverse event reporting did not conform to clinical trial protocols. For patient-reported outcomes, we used mixed methods (including pre-post surveys among a sub-set of COPE participants and qualitative interviews) but did not collect or compare data from a control arm.

Results Point of Contact

• Title: Dr. Sonya Shin
• Organization: Brigham and Women's Hospital

sshin@bwh.harvard.edu

617-872-0310

Study Officials

• Sonya S Shin, MD MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 31, 2017
• Study Start: November 1, 2013
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: May 27, 2026
• Results First Posted: December 16, 2025

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)