Trial Outcomes & Findings for Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program (NCT NCT03326206)

NCT ID: NCT03326206

Last Updated: 2026-05-27

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

28813 participants

Primary outcome timeframe

24 months

Results posted on

2026-05-27

Participant Flow

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.

Of 28813 individuals screened for eligibility, 3053 were met eligibility criteria and were included (enrolled) in the study

Participant milestones

Participant milestones
Measure
COPE Participants
Individuals with diabetes seen at a study site and enrolled in 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 deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers 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 .
Overall Study - 24 months
STARTED
173
2880
Overall Study - 24 months
COMPLETED
173
2880
Overall Study - 24 months
NOT COMPLETED
0
0
12 months
STARTED
173
2880
12 months
COMPLETED
173
2880
12 months
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data missing on variable in observational database

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
COPE Participants
n=173 Participants
Individuals with diabetes seen at a study site and enrolled in 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 deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.
Non-COPE Participants
n=2880 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
Total
n=3053 Participants
Total of all reporting groups
Age, Customized
18-24 years old
0 Participants
n=173 Participants
0 Participants
n=2880 Participants
0 Participants
n=3053 Participants
Age, Customized
25-40 years old
7 Participants
n=173 Participants
46 Participants
n=2880 Participants
53 Participants
n=3053 Participants
Age, Customized
41-55 years old
33 Participants
n=173 Participants
610 Participants
n=2880 Participants
643 Participants
n=3053 Participants
Age, Customized
56-70 years old
74 Participants
n=173 Participants
1436 Participants
n=2880 Participants
1510 Participants
n=3053 Participants
Age, Customized
71-85 years old
54 Participants
n=173 Participants
764 Participants
n=2880 Participants
818 Participants
n=3053 Participants
Age, Customized
> 85 years old
5 Participants
n=173 Participants
24 Participants
n=2880 Participants
29 Participants
n=3053 Participants
Sex: Female, Male
Female
108 Participants
n=173 Participants
1979 Participants
n=2880 Participants
2087 Participants
n=3053 Participants
Sex: Female, Male
Male
65 Participants
n=173 Participants
901 Participants
n=2880 Participants
966 Participants
n=3053 Participants
Race/Ethnicity, Customized
American Indian / Alaska Native
173 Participants
n=173 Participants
2880 Participants
n=2880 Participants
3053 Participants
n=3053 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=173 Participants
0 Participants
n=2880 Participants
0 Participants
n=3053 Participants
Region of Enrollment
United States · Navajo Area Indian Health Services
173 Participants
n=173 Participants
2880 Participants
n=2880 Participants
3053 Participants
n=3053 Participants
Region of Enrollment
United States · Other
0 Participants
n=173 Participants
0 Participants
n=2880 Participants
0 Participants
n=3053 Participants
Preferred language
Navajo or other Native American language
100 Participants
n=172 Participants • Data missing on variable in observational database
1178 Participants
n=2878 Participants • Data missing on variable in observational database
1278 Participants
n=3050 Participants • Data missing on variable in observational database
Preferred language
English
72 Participants
n=172 Participants • Data missing on variable in observational database
1700 Participants
n=2878 Participants • Data missing on variable in observational database
1772 Participants
n=3050 Participants • Data missing on variable in observational database
Primary Care Physician
Primary Care Provider assigned
146 Participants
n=173 Participants
2577 Participants
n=2880 Participants
2723 Participants
n=3053 Participants
Primary Care Physician
No Primary Care Provider assigned
27 Participants
n=173 Participants
303 Participants
n=2880 Participants
330 Participants
n=3053 Participants
Essential hypertension
Yes
113 Participants
n=173 Participants • Data missing on variable in observational database
1966 Participants
n=2875 Participants • Data missing on variable in observational database
2079 Participants
n=3048 Participants • Data missing on variable in observational database
Essential hypertension
No
60 Participants
n=173 Participants • Data missing on variable in observational database
909 Participants
n=2875 Participants • Data missing on variable in observational database
969 Participants
n=3048 Participants • Data missing on variable in observational database
Major Depressive Disorder
Yes
25 Participants
n=173 Participants • Data missing on variable in observational database
282 Participants
n=2875 Participants • Data missing on variable in observational database
307 Participants
n=3048 Participants • Data missing on variable in observational database
Major Depressive Disorder
No
148 Participants
n=173 Participants • Data missing on variable in observational database
2593 Participants
n=2875 Participants • Data missing on variable in observational database
2741 Participants
n=3048 Participants • Data missing on variable in observational database
Major cardiovascular disease
Yes
123 Participants
n=173 Participants • Data missing on variable in observational database
2050 Participants
n=2875 Participants • Data missing on variable in observational database
2173 Participants
n=3048 Participants • Data missing on variable in observational database
Major cardiovascular disease
No
50 Participants
n=173 Participants • Data missing on variable in observational database
825 Participants
n=2875 Participants • Data missing on variable in observational database
875 Participants
n=3048 Participants • Data missing on variable in observational database
Dyslipidemia
Yes
80 Participants
n=173 Participants • Data missing on variable in observational database
1688 Participants
n=2875 Participants • Data missing on variable in observational database
1768 Participants
n=3048 Participants • Data missing on variable in observational database
Dyslipidemia
No
93 Participants
n=173 Participants • Data missing on variable in observational database
1187 Participants
n=2875 Participants • Data missing on variable in observational database
1280 Participants
n=3048 Participants • Data missing on variable in observational database
Alcohol Use Disorder
Yes
11 Participants
n=173 Participants • Data missing on variable in observational database
77 Participants
n=2875 Participants • Data missing on variable in observational database
88 Participants
n=3048 Participants • Data missing on variable in observational database
Alcohol Use Disorder
No
162 Participants
n=173 Participants • Data missing on variable in observational database
2798 Participants
n=2875 Participants • Data missing on variable in observational database
2960 Participants
n=3048 Participants • Data missing on variable in observational database

PRIMARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2880 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Percentage of Glycated Hemoglobin (HbA1c)
-0.49 percent
Interval -0.62 to -0.37
0.13 percent
Interval 0.1 to 0.17

SECONDARY outcome

Timeframe: 24 months

Changes in systolic blood pressure at 24 months, compared with baseline

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2880 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Systolic Blood Pressure
1.43 mmHg
Interval 0.67 to 2.18
0.28 mmHg
Interval 0.06 to 0.5

SECONDARY outcome

Timeframe: 24 months

Change in low density lipoprotein at 24 months, compared with baseline

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2880 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Low-density Lipoprotein
-8.04 mg/dl
Interval -11.88 to -4.2
-3.21 mg/dl
Interval -4.17 to -2.24

SECONDARY outcome

Timeframe: 24 months

change in body mass index at 24 months, compared with baseline

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2880 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Body Mass Index
-0.25 kg/m^2
Interval -0.51 to 0.01
-0.26 kg/m^2
Interval -0.34 to -0.18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Primary Outpatient Services
1.0750 number of visits per quarter post enroll
Interval 0.9618 to 1.2016
0.9224 number of visits per quarter post enroll
Interval 0.8952 to 0.9505

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Specialty Outpatient Services
0.8856 number of visits per quarter post enroll
Interval 0.772 to 1.016
0.6838 number of visits per quarter post enroll
Interval 0.661 to 0.7074

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Emergency Services
0.2755 number of visits per quarter post enroll
Interval 0.2306 to 0.329
0.2559 number of visits per quarter post enroll
Interval 0.2448 to 0.2674

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Counseling / Behavioral Services
0.2590 number of visits per quarter post enroll
Interval 0.2164 to 0.3101
0.1432 number of visits per quarter post enroll
Interval 0.1363 to 0.1504

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Laboratory Services
0.3510 number of visits per quarter post enroll
Interval 0.2838 to 0.4341
0.2798 number of visits per quarter post enroll
Interval 0.265 to 0.2955

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Radiology Services
0.0304 encounters per patient per quarter
Interval 0.0222 to 0.0416
0.0220 encounters per patient per quarter
Interval 0.0202 to 0.024

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Pharmacy Services
0.5477 number of visits per quarter post enroll
Interval 0.4816 to 0.6229
0.5146 number of visits per quarter post enroll
Interval 0.4977 to 0.5321

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Inpatient Services
0.1869 number of visits per quarter post enroll
Interval 0.1436 to 0.2433
0.1592 number of visits per quarter post enroll
Interval 0.1491 to 0.1699

SECONDARY outcome

Timeframe: 24 months

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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Dental Encounters
0.1119 number of visits per quarter post enroll
Interval 0.0875 to 0.1429
0.1422 number of visits per quarter post enroll
Interval 0.1344 to 0.1505

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=173 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=2885 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Change in Community Encounters
0.1160 number of visits per quarter post enroll
Interval 0.09 to 0.1497
0.0189 number of visits per quarter post enroll
Interval 0.0171 to 0.0207

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: For this outcome, only pre-post analysis was collected among a subset of COPE participants (rather than COPE v. non-COPE arms)

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.

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=22 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=22 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Patient-reported Good Health
Good health · Yes
15 Participants
12 Participants
Patient-reported Good Health
Good health · No
7 Participants
10 Participants
Patient-reported Good Health
Good health compared to a year ago · Yes
13 Participants
18 Participants
Patient-reported Good Health
Good health compared to a year ago · No
9 Participants
4 Participants
Patient-reported Good Health
Good health compared to other people your age · Yes
13 Participants
18 Participants
Patient-reported Good Health
Good health compared to other people your age · No
9 Participants
4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: For this outcome, only pre-post analysis was collected among a subset of COPE participants (rather than COPE v. non-COPE arms)

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"

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=22 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=22 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Patient-reported Sense of Control
Yes
7 Participants
10 Participants
Patient-reported Sense of Control
No
15 Participants
12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: For this outcome, only pre-post analysis was collected among a subset of COPE participants (rather than COPE v. non-COPE arms)

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"

Outcome measures

Outcome measures
Measure
COPE Participants - Baseline
n=22 Participants
Survey data administered to patients at the time of enrollment into the COPE Program
COPE Participants - 12 Months
n=22 Participants
Surveys administered to patients after 1 year of participation in the COPE program
Patient-reported Ability to Cope
Able to cope with all the things you had to do · Yes
6 Participants
14 Participants
Patient-reported Ability to Cope
Able to cope with all the things you had to do · No
16 Participants
8 Participants
Patient-reported Ability to Cope
Able to cope with unexpected negative events · Yes
2 Participants
12 Participants
Patient-reported Ability to Cope
Able to cope with unexpected negative events · No
20 Participants
10 Participants

Adverse Events

COPE Participants

Serious events: 2 serious events
Other events: 54 other events
Deaths: 8 deaths

Non-COPE Participants

Serious events: 3 serious events
Other events: 493 other events
Deaths: 92 deaths

Serious adverse events

Serious adverse events
Measure
COPE Participants
n=173 participants at risk
Individuals with diabetes seen at a study site and enrolled in 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 deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.
Non-COPE Participants
n=2885 participants at risk
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
Cardiac disorders
Incident CVD
1.2%
2/173 • Number of events 2 • 24 months
Because this study was an observational, prospective study, adverse events are reported based on routine clinical data during the study period: 1) all-cause mortality; 2) serious adverse events defined as incident cardiovascular disease; 3) non serious adverse events were not collected
0.10%
3/2885 • Number of events 3 • 24 months
Because this study was an observational, prospective study, adverse events are reported based on routine clinical data during the study period: 1) all-cause mortality; 2) serious adverse events defined as incident cardiovascular disease; 3) non serious adverse events were not collected

Other adverse events

Other adverse events
Measure
COPE Participants
n=173 participants at risk
Individuals with diabetes seen at a study site and enrolled in 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 deliver structured health coaching, monitor vital signs and blood glucose levels, facilitate access to appointments and medication refills, and communicate with providers to address acute issues that may arise.
Non-COPE Participants
n=2885 participants at risk
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
Endocrine disorders
Inpatient hospitalization
31.2%
54/173 • Number of events 145 • 24 months
Because this study was an observational, prospective study, adverse events are reported based on routine clinical data during the study period: 1) all-cause mortality; 2) serious adverse events defined as incident cardiovascular disease; 3) non serious adverse events were not collected
17.1%
493/2885 • Number of events 790 • 24 months
Because this study was an observational, prospective study, adverse events are reported based on routine clinical data during the study period: 1) all-cause mortality; 2) serious adverse events defined as incident cardiovascular disease; 3) non serious adverse events were not collected

Additional Information

Dr. Sonya Shin

Brigham and Women's Hospital

Phone: 617-872-0310

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place