An observational study in Diabetes Mellitus, Metabolic Syndrome and Hypertension, sponsored by Brigham and Women's Hospital. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Brigham and Women's Hospital · Observational
Among 47 studies in Diabetes Mellitus by Brigham and Women's Hospital — 2 open to participants now, 3 under way, none of them phase 3. Diabetes Mellitus · Brigham and Women's Hospital.
Among the 47 studies in Diabetes Mellitus by Brigham and Women's Hospital, this one is the 10th largest by enrollment of the 16 observational ones that give a count, is one of 6 that started in 2013, is one of 17 observational ones, and was the 28th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
Browse Diabetes Mellitus studies →2 of the 47 studies in Diabetes Mellitus by Brigham and Women's Hospital are open now, in 1 country. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Ages 55+ · Healthy volunteers
Brigham and Women's Hospital · Sites in United States
Ages 30+
By country, each count listing its studies:
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
First in 1980; this study’s year is marked. 6 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 28,813 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Median enrollment 184 across the 30 interventional studies, 75,810 across the 16 observational. Of the 38 that completed or were terminated, 9 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
2 of the studies in Diabetes Mellitus by Brigham and Women's Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05759468Brigham and Women's HospitalNAD Augmentation in Diabetes Kidney Disease | 2026-11-30 |
| NCT06051058Brigham and Women's HospitalCare Transitions App for Patients With Multiple Chronic Conditions | 2027-06 |
Add all 2 to your calendar (.ics) → With an account.
Among the 47 studies in Diabetes Mellitus by Brigham and Women's Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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:
Individuals receiving care at a Navajo Area Indian Health Service facility, living with diabetes
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics.
Change in Percentage of Glycated Hemoglobin (HbA1c)
Change in Hemoglobin A1c measured at 24 months, compared with baseline
Time frame: 24 months
Change in Systolic Blood Pressure
Changes in systolic blood pressure at 24 months, compared with baseline
Time frame: 24 months
Change in Low-density Lipoprotein
Change in low density lipoprotein at 24 months, compared with baseline
Time frame: 24 months
Change in Body Mass Index
change in body mass index at 24 months, compared with baseline
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 24 months
Patient-reported Good Health
Health status is assessed by three questions using a 5-point scale response to the General Health question from the Short Form 12 survey: "Would you say that in general your health is…" "Compared to your health a year ago, would you say your health is" and "Compared to other people your age, would you say your health is" (Excellent=5, Very Good=4, Good=3, Fair=2, Poor=1), where higher values are more favorable. Binary outcome of Good Health includes "Excellent," "Very good" and "Good" as yes, other responses as no.
Time frame: 12 months
Patient-reported Sense of Control
Sense of control is assessed using a 4-point scale response to the question "Do you feel you are in control of your health?" (Always Never=1, Rarely=2, Sometimes=3, Almost Always=4) with a higher value representing a favorable outcome. Binary outcome derived by including "Almost Always" in "Yes" and "Always never," "Rarely" and "Sometimes" in "No"
Time frame: 12 months
Patient-reported Ability to Cope
Coping will be assessed using a 4-point scale response to two questions "how often have you found that you couldn't cope with all the things that you had to do to?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) and "In the last month, how often have you been upset because of something that happened unexpectedly?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) with a higher value representing a favorable outcome. Binary variables derived by grouping "Always never" and "Rarely" as "Yes" and all others responses as "No"
Time frame: 12 months
COPE participants are recruited to the program as part of routine care. Providers and CHRs identify individuals with uncontrolled chronic diseases, and invite them to participate in the program. Recruitment is programmatic, and not under research auspices.
| Milestone | COPE Participants | Non-COPE Participants |
|---|---|---|
| Started | 173 | 2880 |
| Completed | 173 | 2880 |
| Not completed | 0 | 0 |
| Milestone | COPE Participants | Non-COPE Participants |
|---|---|---|
| Started | 173 | 2880 |
| Completed | 173 | 2880 |
| Not completed | 0 | 0 |
Change in Hemoglobin A1c measured at 24 months, compared with baseline
| percent | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Percentage of Glycated Hemoglobin (HbA1c) | -0.49 (-0.62 to -0.37) | 0.13 (0.10 to 0.17) |
Changes in systolic blood pressure at 24 months, compared with baseline
| mmHg | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Systolic Blood Pressure | 1.43 (0.67 to 2.18) | 0.28 (0.06 to 0.50) |
Change in low density lipoprotein at 24 months, compared with baseline
| mg/dl | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Low-density Lipoprotein | -8.04 (-11.88 to -4.20) | -3.21 (-4.17 to -2.24) |
change in body mass index at 24 months, compared with baseline
| kg/m^2 | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Body Mass Index | -0.25 (-0.51 to 0.01) | -0.26 (-0.34 to -0.18) |
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.
| number of visits per quarter post enroll | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Primary Outpatient Services | 1.0750 (0.9618 to 1.2016) | 0.9224 (0.8952 to 0.9505) |
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.
| number of visits per quarter post enroll | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Specialty Outpatient Services | 0.8856 (0.7720 to 1.0160) | 0.6838 (0.6610 to 0.7074) |
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.
| number of visits per quarter post enroll | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Emergency Services | 0.2755 (0.2306 to 0.3290) | 0.2559 (0.2448 to 0.2674) |
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.
| number of visits per quarter post enroll | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Counseling / Behavioral Services | 0.2590 (0.2164 to 0.3101) | 0.1432 (0.1363 to 0.1504) |
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.
| number of visits per quarter post enroll | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Laboratory Services | 0.3510 (0.2838 to 0.4341) | 0.2798 (0.2650 to 0.2955) |
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.
| encounters per patient per quarter | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Radiology Services | 0.0304 (0.0222 to 0.0416) | 0.0220 (0.0202 to 0.0240) |
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.
| number of visits per quarter post enroll | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Pharmacy Services | 0.5477 (0.4816 to 0.6229) | 0.5146 (0.4977 to 0.5321) |
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.
| number of visits per quarter post enroll | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Inpatient Services | 0.1869 (0.1436 to 0.2433) | 0.1592 (0.1491 to 0.1699) |
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.
| number of visits per quarter post enroll | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Dental Encounters | 0.1119 (0.0875 to 0.1429) | 0.1422 (0.1344 to 0.1505) |
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
| number of visits per quarter post enroll | COPE Participants | Non-COPE Participants |
|---|---|---|
| Change in Community Encounters | 0.1160 (0.0900 to 0.1497) | 0.0189 (0.0171 to 0.0207) |
Health status is assessed by three questions using a 5-point scale response to the General Health question from the Short Form 12 survey: "Would you say that in general your health is…" "Compared to your health a year ago, would you say your health is" and "Compared to other people your age, would you say your health is" (Excellent=5, Very Good=4, Good=3, Fair=2, Poor=1), where higher values are more favorable. Binary outcome of Good Health includes "Excellent," "Very good" and "Good" as yes, other responses as no.
| Participants | COPE Participants - Baseline | COPE Participants - 12 Months |
|---|---|---|
| Good health — Yes | 15 | 12 |
| Good health — No | 7 | 10 |
| Good health compared to a year ago — Yes | 13 | 18 |
| Good health compared to a year ago — No | 9 | 4 |
| Good health compared to other people your age — Yes | 13 | 18 |
| Good health compared to other people your age — No | 9 | 4 |
Sense of control is assessed using a 4-point scale response to the question "Do you feel you are in control of your health?" (Always Never=1, Rarely=2, Sometimes=3, Almost Always=4) with a higher value representing a favorable outcome. Binary outcome derived by including "Almost Always" in "Yes" and "Always never," "Rarely" and "Sometimes" in "No"
| Participants | COPE Participants - Baseline | COPE Participants - 12 Months |
|---|---|---|
| Yes | 7 | 10 |
| No | 15 | 12 |
Coping will be assessed using a 4-point scale response to two questions "how often have you found that you couldn't cope with all the things that you had to do to?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) and "In the last month, how often have you been upset because of something that happened unexpectedly?" (Always Never=4, Rarely=3, Sometimes=2, Almost Always=1) with a higher value representing a favorable outcome. Binary variables derived by grouping "Always never" and "Rarely" as "Yes" and all others responses as "No"
| Participants | COPE Participants - Baseline | COPE Participants - 12 Months |
|---|---|---|
| Able to cope with all the things you had to do — Yes | 6 | 14 |
| Able to cope with all the things you had to do — No | 16 | 8 |
| Able to cope with unexpected negative events — Yes | 2 | 12 |
| Able to cope with unexpected negative events — No | 20 | 10 |
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COPE Participants | 8/173 (4.6%) | 2/173 (1.2%) | 54/173 (31.2%) |
| Non-COPE Participants | 92/2,885 (3.2%) | 3/2,885 (0.1%) | 493/2,885 (17.1%) |
| Event | COPE Participants | Non-COPE Participants |
|---|---|---|
| Incident CVDCardiac disorders | 2/173 | 3/2885 |
| Event | COPE Participants | Non-COPE Participants |
|---|---|---|
| Inpatient hospitalizationEndocrine disorders | 54/173 | 493/2885 |
The numbers for results differ from those of participant flow because the n for each baseline characteristic depended on data available from health record abstractions.
| Age, Customized(Participants) | COPE Participants | Non-COPE Participants | Total |
|---|---|---|---|
| 18-24 years old | 0 | 0 | 0 |
| 25-40 years old | 7 | 46 | 53 |
| 41-55 years old | 33 | 610 | 643 |
| 56-70 years old | 74 | 1436 | 1510 |
| 71-85 years old | 54 | 764 | 818 |
| > 85 years old | 5 | 24 | 29 |
| Sex: Female, Male(Participants) | COPE Participants | Non-COPE Participants | Total |
|---|---|---|---|
| Female | 108 | 1979 | 2087 |
| Male | 65 | 901 | 966 |
| Race/Ethnicity, Customized(Participants) | COPE Participants | Non-COPE Participants | Total |
|---|---|---|---|
| American Indian / Alaska Native | 173 | 2880 | 3053 |
| Other | 0 | 0 | 0 |
| Region of Enrollment(Participants) | COPE Participants | Non-COPE Participants | Total |
|---|---|---|---|
| United States — Navajo Area Indian Health Services | 173 | 2880 | 3053 |
| United States — Other | 0 | 0 | 0 |
| Preferred language(Participants) | COPE Participants | Non-COPE Participants | Total |
|---|---|---|---|
| Navajo or other Native American language | 100 | 1178 | 1278 |
| English | 72 | 1700 | 1772 |
| Primary Care Physician(Participants) | COPE Participants | Non-COPE Participants | Total |
|---|---|---|---|
| Primary Care Provider assigned | 146 | 2577 | 2723 |
| No Primary Care Provider assigned | 27 | 303 | 330 |
| Essential hypertension(Participants) | COPE Participants | Non-COPE Participants | Total |
|---|---|---|---|
| Yes | 113 | 1966 | 2079 |
| No | 60 | 909 | 969 |
| Major Depressive Disorder(Participants) | COPE Participants | Non-COPE Participants | Total |
|---|---|---|---|
| Yes | 25 | 282 | 307 |
| No | 148 | 2593 | 2741 |
3 further baseline measures are reported on the registry.
Plan to share: No
Ran from Nov 2013 to primary completion in Dec 2015, 25 months.
Results were first posted in Dec 2025, 9 years 11 months after primary completion.
Of 533 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 175. This study's 25 months is below that.
Counting every sponsor, half of 642 studies reached it within 36 months; a quarter within 14 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brigham and Women's Hospital →