ENABLE CHF-PC (Comprehensive Heartcare For Patients and Caregivers)

Baseline patient-reported Quality of Life (QOL) was measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score, a heart failure-specific 23-item instrument. The KCCQ consists of 4 clinical domains: symptoms - frequency & severity; Physical Limitation; Quality of Life and Social Limitation and captures the patient's perspective of heart failure. Clinical summary scores range from 0 to 100. Higher KCCQ scores indicate better perceived health status. KCCQ clinical summary scores greater than or equal to 50 indicate good QOL.

Patient-reported Quality of Life (QOL) was measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 16 weeks. The KCCQ consists of 4 clinical domains: symptoms - frequency & severity; Physical Limitation; Quality of Life and Social Limitation and captures the patient's perspective of heart failure. Clinical summary scores range from 0 to 100. Higher KCCQ scores indicate better perceived health status. KCCQ clinical summary scores greater than or equal to 50 indicate good QOL.

Baseline patient-reported Quality of Life (QOL) was measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14). Scores range from 0 to 56; higher scores indicate better quality of life.

Patient-reported Quality of Life (QOL) was measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) at 16 weeks. Scores range from 0 to 56; higher scores indicate better quality of life.

Baseline patient & caregiver-reported mood - Anxiety - was measured on the Hospital Anxiety and Depression Scale (HADS). 7 items measure anxiety symptoms.Scores range from 0 to 21; higher scores indicate more severe symptoms.

Change from baseline in patient & caregiver-reported mood - Anxiety was measured on the HADS. 7 items measure anxiety symptoms. Scores range from 0 to 21; higher scores indicate more severe symptoms.

Baseline patient and caregiver-reported depression was measured on the Hospital Anxiety and Depression Scale (HADS). 7 items measure depression symptoms. Scores range from 0 to 21; higher scores indicate more severe symptoms.

Patient and caregiver-reported depression was measured on the Hospital Anxiety and Depression Scale (HADS) at 16 weeks. 7 items measure depression symptoms. Scores range from 0 to 21; higher scores indicate more severe symptoms.

Baseline caregiver-reported quality of life (QOL) was measured on the Bakas Caregiving Outcomes Scale (BCOS). Score range: 15-105; higher scores indicate higher quality of life.

Caregiver-reported quality of life (QOL) was measured on the Bakas Caregiving Outcomes Scale (BCOS) at 16 weeks. Score range: 15-105; higher scores indicate higher quality of life.

Baseline caregiver-reported Objective burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB). This subscale measures the object burden, interference with the caregiver's day-to-day activities given caregiving demands. Score range: 6-30, Greater than 23 indicates high burden.

Caregiver-reported Objective burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 16 weeks. This subscale measures the object burden, interference with the caregiver's day-to-day activities given caregiving demands.Score range: 6-30, Greater than 23 indicates high burden.

Baseline caregiver-reported Demand burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB). This subscale measures the demand burden or the strain among caregivers from meeting the needs of the care recipient. Score range: 6-30, Greater than 23 indicates high burden.

Caregiver-reported Demand burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 16 weeks. This subscale measures the demand burden or the strain among caregivers from meeting the needs of the care recipient. Score range: 6-30, Greater than 23 indicates high burden.

Baseline caregiver-reported Stress burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB). his subscale indicates the stress burden or emotional stress from the demands of caregiving. Score range: 6-30, Greater than 23 indicates high burden.

Caregiver-reported Stress burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 16 weeks. This subscale indicates the stress burden or emotional stress from the demands of caregiving. Score range: 6-30, Greater than 23 indicates high burden.

Baseline patient- and caregiver-reported PHYSICAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.

Patient- and caregiver-reported PHYSICAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health at 16 weeks. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.

Baseline patient- and caregiver-reported MENTAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.

Patient- and caregiver-reported MENTAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health at 16 weeks. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.

Baseline patient-reported symptom burden was measured on symptom-based items from the Kansas City Cardiomyopathy Questionnaire (KCCQ). Higher KCCQ scores indicate better perceived health status. The KCCQ Symptom burden domain consists of 8 items and quantifies the frequency, severity and change over time with clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ symptom domain scores range from 0 to 100; A score of 50 is the threshold between unstable heart failure symptoms (<50) or stable heart failure symptoms (>=50).

Patient-reported symptom burden was measured on symptom-based items from the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 16 weeks. Higher KCCQ scores indicate better perceived health status. The KCCQ Symptom burden domain consists of 8 items and quantifies the frequency, severity and change over time for clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ symptom domain scores range from 0 to 100; A score of 50 is the threshold between unstable heart failure symptoms (<50) or stable heart failure symptoms (>=50).

Baseline patient-reported PAIN INTENSITY was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale. Higher pain scores indicate more pain. Score range: 0-100; Scores greater than 50 indicate high pain.

Patient-reported PAIN INTENSITY was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale at 16 weeks. Higher pain scores indicate more pain. Score range: 0-100; Scores greater than 50 indicate high pain.

Baseline patient-reported PAIN INTERFERENCE was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale. Higher pain interference scores indicate more interference in daily life. Score range: 0-100; Scores greater than 50 indicate high pain.

Patient-reported PAIN INTERFERENCE was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale at 16 weeks. Higher pain interference scores indicate more interference in daily life. Score range: 0-100; Scores greater than 50 indicate high pain.

Baseline patient-reported health care utilization - Number of Days in Hospital, last two months - was measured on the Resource Use Questionnaire. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Days in Hospital is 0 Days to 60 Days (last/previous two months prior to this measure).

Patient-reported health care utilization - Number of Days in Hospital, last two months - was measured on the Resource Use Questionnaire at 16 weeks. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Days in Hospital is 0 Days to 60 Days (last/previous two months prior to this measure).

Baseline patient-reported health care utilization - Number of Emergency Department Visits, last two months - was measured on the Resource Use Questionnaire. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Visits to ED is 0 Visits to 60 Visits (in the last/previous two months prior to this measure).

Patient-reported health care utilization - Number of Emergency Department Visits, last two months - was measured on the Resource Use Questionnaire at 16 weeks. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Visits to ED is 0 Visits to 60 Visits (in the last/previous two months prior to this measure).