Diabetes MellitusNCT03326206
Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
An observational study of Diabetes Mellitus and Metabolic Syndrome, run by Brigham and Women's Hospital at 6 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Metabolic Syndrome, Hypertension
- How many people
- 28,813 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Nov 2013to 31 Dec 2015
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals receiving care at a Navajo Area Indian Health Service facility, living with diabetes
Who may be able to join
- Diagnosis of diabetes
- Treated at a participating IHS facility corresponding to their home residence
Who cannot join
- Not seen in one of the six participating clinical sites
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Chinle Comprehensive Health Care Facility
Chinle, Arizona, 86503
Crownpoint Health Center Facility
Crownpoint, New Mexico, 87313
Tsehootsooi Medical Center
Fort Defiance, Arizona, 86504
Gallup Indian Medical Center
Gallup, New Mexico, 87301
Kayenta Health Center
Kayenta, Arizona, 86033
Northern Navajo Medical Center
Shiprock, New Mexico, 87420
About this study
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.
Read more
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.
Read the detailed description
Study population: The study will take place on the Navajo Reservation and within Navajo Area IHS clinical facilities. The Navajo Reservation covers over 27,000 square miles in rural New Mexico and Arizona. The proposed evaluation will occur at the six sites, including two which are currently implementing COPE as well as four sites which will implement COPE in the next two years. The health care centers included in this evaluation represent a mix of federally and tribally operated programs and together provide care for over 200,000 individuals. All sites use a common suite of software applications to record electronic health care data: the IHS RPMS (Resource Patient Management System).
Study Design: The research is aligned with PCORI's definition of patient-centered research by answering questions that will allow patients and other stakeholders to make informed health care decisions. This will be completed by incorporating patient input at all stages; comparatively assessing the benefits and weaknesses of COPE; capturing the "voice" of stakeholders through qualitative methods; choosing outcomes that have been cited as relevant to patients' own priorities and decision-making; and studying cross-site variation to capture individual and community factors associated with impact. The study will address the following questions:
- Do clinical outcomes (hemoglobin A1c, blood pressure, cholesterol, and body mass index) improve more among COPE participants, compared with similar patients who do not participate in COPE?
- Do COPE patients experience improvements in self-rated overall health, quality of life, empowerment and satisfaction compared with similar patients who do not participate in COPE?
- As COPE is implemented in six different service units across the Navajo Nation, can we identify any factors among patients, CHRs, and hospitals that are "key ingredients" for COPE to be effective?
- Does COPE benefit the health system and population served from diverse stakeholder perspectives including CHRs, providers, and the local health care delivery system?
- Conditions
- Diabetes Mellitus, Metabolic Syndrome, Hypertension, Chronic Disease
- Keywords
- Navajo, Community Health Workers, Community Health Representatives, Tribal health systems, American Indian, Rural, Health disparities
- Medical subject headings
- Diabetes Mellitus, Metabolic Syndrome, Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of Glycated Hemoglobin (HbA1c)
Change in Hemoglobin A1c measured at 24 months, compared with baseline
Measured: 24 months
Secondary outcomes (13)
Change in Systolic Blood Pressure
Changes in systolic blood pressure at 24 months, compared with baseline
Measured: 24 months
Change in Low-density Lipoprotein
Change in low density lipoprotein at 24 months, compared with baseline
Measured: 24 months
Change in Body Mass Index
change in body mass index at 24 months, compared with baseline
Measured: 24 months
Change in Primary Outpatient Services
Primary outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Measured: 24 months
Change in Specialty Outpatient Services
Specialty outpatient encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Measured: 24 months
Change in Emergency Services
Emergency encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Measured: 24 months
Change in Counseling / Behavioral Services
Counseling / behavioral encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Measured: 24 months
Change in Laboratory Services
Laboratory encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Measured: 24 months
Change in Radiology Services
Radiology encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Measured: 24 months
Change in Pharmacy Services
Pharmacy encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each "clinic visit" reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Measured: 24 months
Change in Inpatient Services
For inpatient services, the primary data point is the presence of a DRG code indicating the patient was hospitalized. However, we also included clinic listings for labor and delivery and for observation as inpatient utilization.
Measured: 24 months
Change in Dental Encounters
Dental encounters are identified using the Resource Patient Management System (RPMS) clinic variable. It is notable that the clinic variable includes types of health utilization that are not limited to clinic visits, e.g. inpatient, emergency primary, specialty, dental, counseling/behavioral care. Each clinic visit reported in RPMS is counted as one utilization incident for the purposes of this analysis.
Measured: 24 months
Change in Community Encounters
Community encounters are identified using the Resource Patient Management System (RPMS) clinic variable. Community Encounters may include public health nursing and community health representative visits; however, not all community encounters (e.g. visits by Community Health Representatives in clinics where Community Health Representatives do not document their visits on the RPMS system) may be represented in this database
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Nov 2013
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28,813 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Research Group
- Responsible party
- Principal investigator, Sonya Sunhi Shin, Brigham and Women's Hospital
- Investigators
- Sonya S Shin, MD MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326206
- Sponsor's protocol ID
- AD-1304-6566
- Status last verified
- May 2026
- First submitted
- 24 Oct 2017
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32450874Brown 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.
PubMed 32054623Lalla 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.
PubMed 31914997Trevisi 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.
PubMed 31771603