Chronic Disease, Diabetes Mellitus, Hypertension, Metabolic Syndrome
Conditions
Keywords
Navajo, Community Health Workers, Community Health Representatives, Tribal health systems, American Indian, Rural, Health disparities
Brief summary
Since 2009, a programmatic community-based strategy (COPE) has been implemented to address health disparities among Navajo individuals living with multiple chronic conditions. COPE (Community Outreach and Patient Empowerment) targets individual, family, and health system-level factors through four activities: 1) 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.
Detailed description
Study population: The study will take place on the Navajo Reservation and within Navajo Area IHS clinical facilities. The Navajo Reservation covers over 27,000 square miles in rural New Mexico and Arizona. The proposed evaluation will occur at the six sites, including two which are currently implementing COPE as well as four sites which will implement COPE in the next two years. The health care centers included in this evaluation represent a mix of federally and tribally operated programs and together provide care for over 200,000 individuals. All sites use a common suite of software applications to record electronic health care data: the IHS RPMS (Resource Patient Management System). Study Design: The research is aligned with PCORI's definition of patient-centered research by answering questions that will allow patients and other stakeholders to make informed health care decisions. This will be completed by incorporating patient input at all stages; comparatively assessing the benefits and weaknesses of COPE; capturing the "voice" of stakeholders through qualitative methods; choosing outcomes that have been cited as relevant to patients' own priorities and decision-making; and studying cross-site variation to capture individual and community factors associated with impact. The study will address the following questions: 1. Do clinical outcomes (hemoglobin A1c, blood pressure, cholesterol, and body mass index) improve more among COPE participants, compared with similar patients who do not participate in COPE? 2. Do COPE patients experience improvements in self-rated overall health, quality of life, empowerment and satisfaction compared with similar patients who do not participate in COPE? 3. As COPE is implemented in six different service units across the Navajo Nation, can we identify any factors among patients, CHRs, and hospitals that are "key ingredients" for COPE to be effective? 4. Does COPE benefit the health system and population served from diverse stakeholder perspectives including CHRs, providers, and the local health care delivery system?
Interventions
None listed
Sponsors
Brigham and Women's Hospital
Eastern Research Group
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of diabetes * Treated at a participating IHS facility corresponding to their home residence
Exclusion criteria
* Not seen in one of the six participating clinical sites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Glycated Hemoglobin (HbA1c) | 24 months | Change in Hemoglobin A1c measured at 24 months, compared with baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | 24 months | Changes in systolic blood pressure at 24 months, compared with baseline |
| Change in Low-density Lipoprotein | 24 months | Change in low density lipoprotein at 24 months, compared with baseline |
| Change in Body Mass Index | 24 months | change in body mass index at 24 months, compared with baseline |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Change in Pharmacy Services | 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. |
| Change in Inpatient Services | 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. |
| Change in Dental Encounters | 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. |
| Change in Community Encounters | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSonya S Shin, MD MPH
Brigham and Women's Hospital
Participant flow
Recruitment details
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.
Pre-assignment details
Of 28813 individuals screened for eligibility, 3053 were met eligibility criteria and were included (enrolled) in the study
Participants by arm
| Arm | Count |
|---|---|
| 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. | 173 |
| 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 . | 2,880 |
| Total | 3,053 |
Baseline characteristics
| Characteristic | COPE Participants | Non-COPE Participants | Total |
|---|---|---|---|
| Age, Customized 18-24 years old | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 25-40 years old | 7 Participants | 46 Participants | 53 Participants |
| Age, Customized 41-55 years old | 33 Participants | 610 Participants | 643 Participants |
| Age, Customized 56-70 years old | 74 Participants | 1436 Participants | 1510 Participants |
| Age, Customized 71-85 years old | 54 Participants | 764 Participants | 818 Participants |
| Age, Customized > 85 years old | 5 Participants | 24 Participants | 29 Participants |
| Alcohol Use Disorder No | 162 Participants | 2798 Participants | 2960 Participants |
| Alcohol Use Disorder Yes | 11 Participants | 77 Participants | 88 Participants |
| Dyslipidemia No | 93 Participants | 1187 Participants | 1280 Participants |
| Dyslipidemia Yes | 80 Participants | 1688 Participants | 1768 Participants |
| Essential hypertension No | 60 Participants | 909 Participants | 969 Participants |
| Essential hypertension Yes | 113 Participants | 1966 Participants | 2079 Participants |
| Major cardiovascular disease No | 50 Participants | 825 Participants | 875 Participants |
| Major cardiovascular disease Yes | 123 Participants | 2050 Participants | 2173 Participants |
| Major Depressive Disorder No | 148 Participants | 2593 Participants | 2741 Participants |
| Major Depressive Disorder Yes | 25 Participants | 282 Participants | 307 Participants |
| Preferred language English | 72 Participants | 1700 Participants | 1772 Participants |
| Preferred language Navajo or other Native American language | 100 Participants | 1178 Participants | 1278 Participants |
| Primary Care Physician No Primary Care Provider assigned | 27 Participants | 303 Participants | 330 Participants |
| Primary Care Physician Primary Care Provider assigned | 146 Participants | 2577 Participants | 2723 Participants |
| Race/Ethnicity, Customized American Indian / Alaska Native | 173 Participants | 2880 Participants | 3053 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States Navajo Area Indian Health Services | 173 Participants | 2880 Participants | 3053 Participants |
| Region of Enrollment United States Other | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 108 Participants | 1979 Participants | 2087 Participants |
| Sex: Female, Male Male | 65 Participants | 901 Participants | 966 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 173 | 92 / 2,885 |
| other Total, other adverse events | 54 / 173 | 493 / 2,885 |
| serious Total, serious adverse events | 2 / 173 | 3 / 2,885 |
Outcome results
Primary
Change in Percentage of Glycated Hemoglobin (HbA1c)
Change in Hemoglobin A1c measured at 24 months, compared with baseline
Time frame: 24 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Percentage of Glycated Hemoglobin (HbA1c) | -0.49 percent |
| Non-COPE participants | Change in Percentage of Glycated Hemoglobin (HbA1c) | 0.13 percent |
Comparison: Mixed linear regression models were performed to assess differences over time for continuous variables, comparing COPE versus control groups. The models included a random effect for patients to account for within-patient correlation over time in the outcome measures and a random effect for the primary health facility, to account for within-site correlation. In the sensitivity analyses we also adjusted the models for the random effect of matching groups.p-value: <0.0001Regression, Linear
Secondary
Change in Body Mass Index
change in body mass index at 24 months, compared with baseline
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| COPE participants | Change in Body Mass Index | -0.25 kg/m^2 |
| Non-COPE participants | Change in Body Mass Index | -0.26 kg/m^2 |
p-value: 0.93Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Community Encounters | 0.1160 number of visits per quarter post enroll |
| Non-COPE participants | Change in Community Encounters | 0.0189 number of visits per quarter post enroll |
p-value: <0.0001Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Counseling / Behavioral Services | 0.2590 number of visits per quarter post enroll |
| Non-COPE participants | Change in Counseling / Behavioral Services | 0.1432 number of visits per quarter post enroll |
Comparison: As described for primary outpatient servicesp-value: <0.0001Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Dental Encounters | 0.1119 number of visits per quarter post enroll |
| Non-COPE participants | Change in Dental Encounters | 0.1422 number of visits per quarter post enroll |
p-value: 0.0613Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Emergency Services | 0.2755 number of visits per quarter post enroll |
| Non-COPE participants | Change in Emergency Services | 0.2559 number of visits per quarter post enroll |
Comparison: as described for primary outpatient servicesp-value: 0.4296Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Inpatient Services | 0.1869 number of visits per quarter post enroll |
| Non-COPE participants | Change in Inpatient Services | 0.1592 number of visits per quarter post enroll |
p-value: 0.2461Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Laboratory Services | 0.3510 number of visits per quarter post enroll |
| Non-COPE participants | Change in Laboratory Services | 0.2798 number of visits per quarter post enroll |
p-value: 0.0431Regression, Linear
Secondary
Change in Low-density Lipoprotein
Change in low density lipoprotein at 24 months, compared with baseline
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| COPE participants | Change in Low-density Lipoprotein | -8.04 mg/dl |
| Non-COPE participants | Change in Low-density Lipoprotein | -3.21 mg/dl |
p-value: 0.02Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Pharmacy Services | 0.5477 number of visits per quarter post enroll |
| Non-COPE participants | Change in Pharmacy Services | 0.5146 number of visits per quarter post enroll |
p-value: 0.3582Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Primary Outpatient Services | 1.0750 number of visits per quarter post enroll |
| Non-COPE participants | Change in Primary Outpatient Services | 0.9224 number of visits per quarter post enroll |
Comparison: Generalized linear mixed regression models were used for count outcomes (SAS 9.3: PROC GLIMMIX) to estimate change in health care visits by COPE pts relative to non-COPE pts. Random effects accounted for within-site correlation at service units. Adjusted for covariates: age, gender, language, primary care physician, and diagnoses: essential hypertension, major depression disorder, alcohol abuse, major cardiovascular disease, and dyslipidemia.p-value: 0.0091Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Radiology Services | 0.0304 encounters per patient per quarter |
| Non-COPE participants | Change in Radiology Services | 0.0220 encounters per patient per quarter |
p-value: 0.0516Regression, Linear
Secondary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| COPE participants | Change in Specialty Outpatient Services | 0.8856 number of visits per quarter post enroll |
| Non-COPE participants | Change in Specialty Outpatient Services | 0.6838 number of visits per quarter post enroll |
Comparison: As described for primary outpatient servicesp-value: 0.0003Regression, Linear
Secondary
Change in Systolic Blood Pressure
Changes in systolic blood pressure at 24 months, compared with baseline
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| COPE participants | Change in Systolic Blood Pressure | 1.43 mmHg |
| Non-COPE participants | Change in Systolic Blood Pressure | 0.28 mmHg |
p-value: 0.004Regression, Linear
Other Pre-specified
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
Population: For this outcome, only pre-post analysis was collected among a subset of COPE participants (rather than COPE v. non-COPE arms)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| COPE participants | Patient-reported Ability to Cope | Able to cope with all the things you had to do | Yes | 6 Participants |
| COPE participants | Patient-reported Ability to Cope | Able to cope with all the things you had to do | No | 16 Participants |
| COPE participants | Patient-reported Ability to Cope | Able to cope with unexpected negative events | Yes | 2 Participants |
| COPE participants | Patient-reported Ability to Cope | Able to cope with unexpected negative events | No | 20 Participants |
| Non-COPE participants | Patient-reported Ability to Cope | Able to cope with unexpected negative events | No | 10 Participants |
| Non-COPE participants | Patient-reported Ability to Cope | Able to cope with all the things you had to do | Yes | 14 Participants |
| Non-COPE participants | Patient-reported Ability to Cope | Able to cope with unexpected negative events | Yes | 12 Participants |
| Non-COPE participants | Patient-reported Ability to Cope | Able to cope with all the things you had to do | No | 8 Participants |
p-value: 0.0028Fisher Exact
Other Pre-specified
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
Population: For this outcome, only pre-post analysis was collected among a subset of COPE participants (rather than COPE v. non-COPE arms)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| COPE participants | Patient-reported Good Health | Good health | Yes | 15 Participants |
| COPE participants | Patient-reported Good Health | Good health | No | 7 Participants |
| COPE participants | Patient-reported Good Health | Good health compared to a year ago | Yes | 13 Participants |
| COPE participants | Patient-reported Good Health | Good health compared to a year ago | No | 9 Participants |
| COPE participants | Patient-reported Good Health | Good health compared to other people your age | Yes | 13 Participants |
| COPE participants | Patient-reported Good Health | Good health compared to other people your age | No | 9 Participants |
| Non-COPE participants | Patient-reported Good Health | Good health compared to other people your age | Yes | 18 Participants |
| Non-COPE participants | Patient-reported Good Health | Good health | Yes | 12 Participants |
| Non-COPE participants | Patient-reported Good Health | Good health compared to a year ago | No | 4 Participants |
| Non-COPE participants | Patient-reported Good Health | Good health | No | 10 Participants |
| Non-COPE participants | Patient-reported Good Health | Good health compared to other people your age | No | 4 Participants |
| Non-COPE participants | Patient-reported Good Health | Good health compared to a year ago | Yes | 18 Participants |
p-value: 0.54Fisher Exact
Other Pre-specified
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
Population: For this outcome, only pre-post analysis was collected among a subset of COPE participants (rather than COPE v. non-COPE arms)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COPE participants | Patient-reported Sense of Control | Yes | 7 Participants |
| COPE participants | Patient-reported Sense of Control | No | 15 Participants |
| Non-COPE participants | Patient-reported Sense of Control | Yes | 10 Participants |
| Non-COPE participants | Patient-reported Sense of Control | No | 12 Participants |
p-value: 0.19Chi-squared