Trial · NCT03326206
Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
NCT03326206, Completed, Brigham and Women's Hospital; results first posted 2025-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program. Trials, record NCT03326206. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03326206
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program
- NCT number
- NCT03326206
- Status
- Completed
- Enrollment
- 28,813 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Diabetes Mellitus, Metabolic Syndrome, Hypertension, Chronic Disease
- First posted
- 2017-10-31
- Last updated
- 2026-05-27
- Results first posted
- 2025-12-16
- 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.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Percentage of Glycated Hemoglobin (HbA1c) | 24 months | Change in Hemoglobin A1c measured at 24 months, compared with baseline |
| Secondary | Change in Systolic Blood Pressure | 24 months | Changes in systolic blood pressure at 24 months, compared with baseline |
| Secondary | Change in Low-density Lipoprotein | 24 months | Change in low density lipoprotein at 24 months, compared with baseline |
| Secondary | Change in Body Mass Index | 24 months | change in body mass index at 24 months, compared with baseline |
| Secondary | Change in Primary Outpatient Services | 24 months | 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. |
| Secondary | Change in Specialty Outpatient Services | 24 months | 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. |
| Secondary | Change in Emergency Services | 24 months | 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. |
| Secondary | Change in Counseling / Behavioral Services | 24 months | 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. |
| Secondary | Change in Laboratory Services | 24 months | 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. |
| Secondary | Change in Radiology Services | 24 months | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Percentage of Glycated Hemoglobin (HbA1c) | 24 months | percent | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Systolic Blood Pressure | 24 months | mmHg | MEAN | |
| SECONDARY | Change in Low-density Lipoprotein | 24 months | mg/dl | MEAN | |
| SECONDARY | Change in Body Mass Index | 24 months | kg/m^2 | MEAN | |
| SECONDARY | Change in Primary Outpatient Services | 24 months | number of visits per quarter post enroll | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Specialty Outpatient Services | 24 months | number of visits per quarter post enroll | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Emergency Services | 24 months | number of visits per quarter post enroll | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Counseling / Behavioral Services | 24 months | number of visits per quarter post enroll | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Laboratory Services | 24 months | number of visits per quarter post enroll | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Radiology Services | 24 months | encounters per patient per quarter | LEAST_SQUARES_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Percentage of Glycated Hemoglobin (HbA1c) | COPE participants | -0.49 | 95% Confidence Interval -0.62 to -0.37 | percent | |
| Change in Percentage of Glycated Hemoglobin (HbA1c) | Non-COPE participants | 0.13 | 95% Confidence Interval 0.10 to 0.17 | percent | |
| Change in Systolic Blood Pressure | COPE participants | 1.43 | 95% Confidence Interval 0.67 to 2.18 | mmHg | |
| Change in Systolic Blood Pressure | Non-COPE participants | 0.28 | 95% Confidence Interval 0.06 to 0.50 | mmHg | |
| Change in Low-density Lipoprotein | COPE participants | -8.04 | 95% Confidence Interval -11.88 to -4.20 | mg/dl | |
| Change in Low-density Lipoprotein | Non-COPE participants | -3.21 | 95% Confidence Interval -4.17 to -2.24 | mg/dl | |
| Change in Body Mass Index | COPE participants | -0.25 | 95% Confidence Interval -0.51 to 0.01 | kg/m^2 | |
| Change in Body Mass Index | Non-COPE participants | -0.26 | 95% Confidence Interval -0.34 to -0.18 | kg/m^2 | |
| Change in Primary Outpatient Services | COPE participants | 1.0750 | 95% Confidence Interval 0.9618 to 1.2016 | number of visits per quarter post enroll | |
| Change in Primary Outpatient Services | Non-COPE participants | 0.9224 | 95% Confidence Interval 0.8952 to 0.9505 | number of visits per quarter post enroll |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study - 24 months | STARTED | COPE participants | 241 | |
| Overall Study - 24 months | STARTED | Non-COPE participants | 28,572 | |
| Overall Study - 24 months | COMPLETED | COPE participants | 173 | |
| Overall Study - 24 months | COMPLETED | Non-COPE participants | 2,880 | |
| Overall Study - 24 months | NOT COMPLETED | COPE participants | 68 | |
| Overall Study - 24 months | NOT COMPLETED | Non-COPE participants | 25,692 | |
| 12 months | STARTED | COPE participants | 241 | |
| 12 months | STARTED | Non-COPE participants | 28,572 | |
| 12 months | COMPLETED | COPE participants | 173 | |
| 12 months | COMPLETED | Non-COPE participants | 2,880 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Inpatient hospitalization | Endocrine disorders | COPE participants | 54 | 173 | 145 |
| other | Inpatient hospitalization | Endocrine disorders | Non-COPE participants | 493 | 2,885 | 790 |
| serious | Incident CVD | Cardiac disorders | COPE participants | 2 | 173 | 2 |
| serious | Incident CVD | Cardiac disorders | Non-COPE participants | 3 | 2,885 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | COPE participants | 8 | 173 |
| Total, all-cause mortality | Non-COPE participants | 92 | 2,885 |
| Total, other adverse events | COPE participants | 54 | 173 |
| Total, other adverse events | Non-COPE participants | 493 | 2,885 |
| Total, serious adverse events | COPE participants | 2 | 173 |
| Total, serious adverse events | Non-COPE participants | 3 | 2,885 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| COPE participants vs Non-COPE participants: deaths from any cause | Trial comparisons |
| COPE participants vs Non-COPE participants: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03326206
GET https://conductscience.org/api/trials/v1/NCT03326206/results?page=2