Trial Outcomes & Findings for Evaluating the Navajo Community Outreach and Patient Empowerment (COPE) Program (NCT NCT03326206)
NCT ID: NCT03326206
Last Updated: 2025-12-16
Results Overview
Change in Hemoglobin A1c measured at 24 months, compared with baseline
COMPLETED
28813 participants
24 months
2025-12-16
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.
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
|
241
|
28572
|
|
Overall Study - 24 months
COMPLETED
|
173
|
2880
|
|
Overall Study - 24 months
NOT COMPLETED
|
68
|
25692
|
|
12 months
STARTED
|
241
|
28572
|
|
12 months
COMPLETED
|
173
|
2880
|
|
12 months
NOT COMPLETED
|
68
|
25692
|
Reasons for withdrawal
| 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
Unable to match cases with controls
|
17
|
22721
|
|
Overall Study - 24 months
Death
|
8
|
92
|
|
Overall Study - 24 months
Observational data not available
|
43
|
2879
|
|
12 months
Unable to match cases with controls
|
17
|
22721
|
|
12 months
Death
|
2
|
50
|
|
12 months
Observational data not available
|
49
|
2921
|
Baseline Characteristics
Data missing on variable in observational database
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 monthsChange in Hemoglobin A1c measured at 24 months, compared with baseline
Outcome measures
| Measure |
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 .
|
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.
|
|---|---|---|
|
Change in Percentage of Glycated Hemoglobin (HbA1c)
|
0.13 percent
Interval 0.1 to 0.17
|
-0.49 percent
Interval -0.62 to -0.37
|
SECONDARY outcome
Timeframe: 24 monthsChanges in systolic blood pressure at 24 months, compared with baseline
Outcome measures
| Measure |
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 .
|
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
0.28 mmHg
Interval 0.06 to 0.5
|
1.43 mmHg
Interval 0.67 to 2.18
|
SECONDARY outcome
Timeframe: 24 monthsChange in low density lipoprotein at 24 months, compared with baseline
Outcome measures
| Measure |
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 .
|
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.
|
|---|---|---|
|
Change in Low-density Lipoprotein
|
-3.21 mg/dl
Interval -4.17 to -2.24
|
-8.04 mg/dl
Interval -11.88 to -4.2
|
SECONDARY outcome
Timeframe: 24 monthschange in body mass index at 24 months, compared with baseline
Outcome measures
| Measure |
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 .
|
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.
|
|---|---|---|
|
Change in Body Mass Index
|
-0.26 kg/m^2
Interval -0.34 to -0.18
|
-0.25 kg/m^2
Interval -0.51 to 0.01
|
SECONDARY outcome
Timeframe: 24 monthsPrimary 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Primary Outpatient Services
|
0.9224 number of visits per quarter post enroll
Interval 0.8952 to 0.9505
|
1.0750 number of visits per quarter post enroll
Interval 0.9618 to 1.2016
|
SECONDARY outcome
Timeframe: 24 monthsSpecialty 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Specialty Outpatient Services
|
0.6838 number of visits per quarter post enroll
Interval 0.661 to 0.7074
|
0.8856 number of visits per quarter post enroll
Interval 0.772 to 1.016
|
SECONDARY outcome
Timeframe: 24 monthsEmergency 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Emergency Services
|
0.2559 number of visits per quarter post enroll
Interval 0.2448 to 0.2674
|
0.2755 number of visits per quarter post enroll
Interval 0.2306 to 0.329
|
SECONDARY outcome
Timeframe: 24 monthsCounseling / 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Counseling / Behavioral Services
|
0.1432 number of visits per quarter post enroll
Interval 0.1363 to 0.1504
|
0.2590 number of visits per quarter post enroll
Interval 0.2164 to 0.3101
|
SECONDARY outcome
Timeframe: 24 monthsLaboratory 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Laboratory Services
|
0.2798 number of visits per quarter post enroll
Interval 0.265 to 0.2955
|
0.3510 number of visits per quarter post enroll
Interval 0.2838 to 0.4341
|
SECONDARY outcome
Timeframe: 24 monthsRadiology 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Radiology Services
|
0.0220 encounters per patient per quarter
Interval 0.0202 to 0.024
|
0.0304 encounters per patient per quarter
Interval 0.0222 to 0.0416
|
SECONDARY outcome
Timeframe: 24 monthsPharmacy 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Pharmacy Services
|
0.5146 number of visits per quarter post enroll
Interval 0.4977 to 0.5321
|
0.5477 number of visits per quarter post enroll
Interval 0.4816 to 0.6229
|
SECONDARY outcome
Timeframe: 24 monthsFor 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Inpatient Services
|
0.1592 number of visits per quarter post enroll
Interval 0.1491 to 0.1699
|
0.1869 number of visits per quarter post enroll
Interval 0.1436 to 0.2433
|
SECONDARY outcome
Timeframe: 24 monthsDental 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Dental Encounters
|
0.1422 number of visits per quarter post enroll
Interval 0.1344 to 0.1505
|
0.1119 number of visits per quarter post enroll
Interval 0.0875 to 0.1429
|
SECONDARY outcome
Timeframe: 24 monthsCommunity 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
| Measure |
Non-COPE participants
n=2885 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
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.
|
|---|---|---|
|
Change in Community Encounters
|
0.0189 number of visits per quarter post enroll
Interval 0.0171 to 0.0207
|
0.1160 number of visits per quarter post enroll
Interval 0.09 to 0.1497
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 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
| Measure |
Non-COPE participants
n=22 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
COPE participants
n=22 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.
|
|---|---|---|
|
Patient-reported Good Health
Good health · Yes
|
12 Participants
|
15 Participants
|
|
Patient-reported Good Health
Good health · No
|
10 Participants
|
7 Participants
|
|
Patient-reported Good Health
Good health compared to a year ago · Yes
|
18 Participants
|
13 Participants
|
|
Patient-reported Good Health
Good health compared to a year ago · No
|
4 Participants
|
9 Participants
|
|
Patient-reported Good Health
Good health compared to other people your age · Yes
|
18 Participants
|
13 Participants
|
|
Patient-reported Good Health
Good health compared to other people your age · No
|
4 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 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
| Measure |
Non-COPE participants
n=22 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
COPE participants
n=22 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.
|
|---|---|---|
|
Patient-reported Sense of Control
Yes
|
10 Participants
|
7 Participants
|
|
Patient-reported Sense of Control
No
|
12 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 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
| Measure |
Non-COPE participants
n=22 Participants
Individuals living with diabetes seen at a study site, did not participate in the COPE programmatic intervention, and had comparable baseline characteristics .
|
COPE participants
n=22 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.
|
|---|---|---|
|
Patient-reported Ability to Cope
Able to cope with all the things you had to do · Yes
|
14 Participants
|
6 Participants
|
|
Patient-reported Ability to Cope
Able to cope with all the things you had to do · No
|
8 Participants
|
16 Participants
|
|
Patient-reported Ability to Cope
Able to cope with unexpected negative events · Yes
|
12 Participants
|
2 Participants
|
|
Patient-reported Ability to Cope
Able to cope with unexpected negative events · No
|
10 Participants
|
20 Participants
|
Adverse Events
COPE participants
Non-COPE participants
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place