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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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Advanced heart failure affects nearly 6 million Americans, and less is known about how this illness affects the 80% of heart failure patients who are 65 years and older because research tends to focus on younger patients. Older patients with heart failure and their family caregivers, rarely have access to palliative supportive care services because the disease is unpredictable and palliative treatment may not be provided until after other medical treatments have been tried. Investigators are studying whether palliative care provided when advanced heart failure patients are still well will result in better quality of life, mood and less symptom distress compared to usual or standard heart failure care.
Specific Aims and Hypotheses:
Specific Aim 1: Determine whether ENABLE CHF-PC leads to higher advanced heart failure patient-reported quality of life (QOL) and mood (depression/anxiety); and lower symptom burden and resource use (e.g. hospital admissions and days, emergency visits) through 16 weeks post baseline.
• Hypothesis 1: Intervention participants will experience higher QOL and mood, and lower symptom burden and resource use through 16 weeks post baseline compared with those receiving usual HF care.
Specific Aim 2: Determine whether ENABLE CHF-PC leads to higher caregiver-reported QOL, mood (anxiety/depression), and self-reported health and lower caregiver burden through 16 weeks post baseline.
• Hypothesis 2: Intervention caregivers will report higher QOL, mood, and self-reported health, and lower caregiver burden through 16 weeks post baseline.
As described.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Intervention | Experimental | Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC |
|
| Usual HF Care | Active Comparator | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Support | Behavioral | ENABLE CHF-PC includes:
The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | 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. | Baseline |
| Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | 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. | 16 weeks |
| Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) | 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. | Baseline |
| Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Bakitas, DNSc | University of Alabama at Birmimgham, School of Nursing, Dept. Acute, Chronic & Continuing Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Veterans Affairs Medical Center (BVAMC) | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham, School of Nursing, Dept. Acute, Chronic and Continuing Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33556493 | Derived | Wells R, Dionne-Odom JN, Azuero A, Buck H, Ejem D, Burgio KL, Stockdill ML, Tucker R, Pamboukian SV, Tallaj J, Engler S, Keebler K, Tims S, Durant R, Swetz KM, Bakitas M. Examining Adherence and Dose Effect of an Early Palliative Care Intervention for Advanced Heart Failure Patients. J Pain Symptom Manage. 2021 Sep;62(3):471-481. doi: 10.1016/j.jpainsymman.2021.01.136. Epub 2021 Feb 5. | |
| 33258422 |
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At this time, the study plans to share data in aggregate and as overall results only.
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The study recruitment period was from October 2015 thru October 2018. Recruitment occurred at two sites: the University of Alabama at Birmingham (UAB) and the Birmingham Veterans Affairs Medical Center (BVAMC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Intervention for Patients | Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes:
The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| FG001 | Usual HF Care for Patients | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| FG002 | Active Intervention for Caregivers | Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes:
The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| FG003 | Usual HF Care for Caregivers | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Intervention for Patients | Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes:
The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | 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. | This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Baseline through 41 months
All cause mortality: Patients - 41 were lost to follow-up & 39 withdrew among 208 patients enrolled and allocated to the intervention group; 61 were lost to follow-up & 9 withdrew of the 207 patients enrolled and allocated to the usual care group.
Caregivers - 31 were lost to follow-up & 19 withdrew of the 82 caregivers enrolled and allocated to the intervention group; 19 were lost to follow-up & 7 withdrew of the 76 caregivers enrolled and allocated to the usual care group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Intervention for Patients | Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes:
The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie A. Bakitas, DNSc, NP-C, FAAN | The University of Alabama at Birmingham, School of Nursing | (205) 934-5277 | mbakitas@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2020 | Jul 26, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 5, 2018 | Aug 30, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
|
| Usual HF Care | Behavioral | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
|
|
| 16 weeks |
| Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) | 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. | Baseline |
| Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) | 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. | 16 weeks |
| Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) | 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. | Baseline |
| Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) | 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. | 16 weeks |
| Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) | 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. | Baseline |
| Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) | 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. | 16 weeks |
| Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | Baseline |
| Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | 16 weeks |
| Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | Baseline |
| Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | 16 weeks |
| Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | Baseline |
| Caregiver Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | 16 weeks |
| Baseline |
| Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 | 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. | 16 weeks |
| Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 | 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. | Baseline |
| Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 | 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. | 16 weeks |
| Patient Symptom Burden as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items | 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). | Baseline |
| Patient Symptom Burden Items as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items. | 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). | 16 weeks |
| Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale | 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. | Baseline |
| Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale | 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. | 16 weeks |
| Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale | 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. | Baseline |
| Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale | 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. | 16 weeks |
| Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument | 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). | Baseline |
| Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument | 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). | 16 weeks |
| Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument | 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). | Baseline |
| Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument | 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). | 16 weeks |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Derived |
| Stockdill ML, Dionne-Odom JN, Wells R, Ejem D, Azuero A, Keebler K, Sockwell E, Tims S, Burgio KL, Engler S, Durant R, Pamboukian SV, Tallaj J, Swetz KM, Kvale E, Tucker R, Bakitas M. African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial. J Palliat Care. 2023 Jan;38(1):52-61. doi: 10.1177/0825859720975978. Epub 2020 Dec 1. |
| 32730613 | Derived | Bakitas MA, Dionne-Odom JN, Ejem DB, Wells R, Azuero A, Stockdill ML, Keebler K, Sockwell E, Tims S, Engler S, Steinhauser K, Kvale E, Durant RW, Tucker RO, Burgio KL, Tallaj J, Swetz KM, Pamboukian SV. Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial. JAMA Intern Med. 2020 Sep 1;180(9):1203-1213. doi: 10.1001/jamainternmed.2020.2861. |
| 32282044 | Derived | Dionne-Odom JN, Ejem DB, Wells R, Azuero A, Stockdill ML, Keebler K, Sockwell E, Tims S, Engler S, Kvale E, Durant RW, Tucker RO, Burgio KL, Tallaj J, Pamboukian SV, Swetz KM, Bakitas MA. Effects of a Telehealth Early Palliative Care Intervention for Family Caregivers of Persons With Advanced Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e202583. doi: 10.1001/jamanetworkopen.2020.2583. |
| 30081933 | Derived | Wells R, Stockdill ML, Dionne-Odom JN, Ejem D, Burgio KL, Durant RW, Engler S, Azuero A, Pamboukian SV, Tallaj J, Swetz KM, Kvale E, Tucker RO, Bakitas M. Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers (ENABLE CHF-PC): study protocol for a randomized controlled trial. Trials. 2018 Aug 6;19(1):422. doi: 10.1186/s13063-018-2770-9. |
| Withdrawal by Subject |
|
| Death |
|
| BG001 | Usual HF Care for Patients | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| BG002 | Active Intervention for Caregivers | Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes:
The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| BG003 | Usual HF Care for Caregivers | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Southeast Region - AL, GA, MS, TN, FL | Count of Participants | Participants |
|
Behavioral: behavioral support
Usual HF Care + ENABLE CHF-PC
Behavioral Support: ENABLE CHF-PC includes:
The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families".
Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
| OG001 | Usual HF Care for Patients | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| OG002 | Active Intervention for Caregivers | Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes:
The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
| OG003 | Usual HF Care for Caregivers | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. |
|
|
| Primary | Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score | 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. | This measure pertains to Patient Quality of Life (QOL) using the KCCQ. Caregiver QOL was analyzed using a different measure. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
|
|
|
| Primary | Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) | 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. | This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) | 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. | This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure. One intervention participant and two usual care participants did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
|
|
|
| Primary | Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) | 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. | This measure pertains to Patient & Caregiver Mood - Anxiety HADS | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Primary | Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) | 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. | This measure pertains to Patient & Caregiver Mood - Anxiety HADS. One intervention patient and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
|
|
|
| Primary | Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) | 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. | This measure pertains to Patient and Caregiver Mood - Depression Scale. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| Primary | Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) | 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. | This measure pertains to Patient and Caregiver Mood - Depression Scale. One intervention patient and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Primary | Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) | 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. | This measure was conducted among Caregiver participants only. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Primary | Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) | 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. | This measure conducted among Caregiver participants only. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Primary | Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only. | Posted | Mean | Standard Error | score on a scale | Baseline |
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| Primary | Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Primary | Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Primary | Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Primary | Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | Montgomery Borgatta Caregiver Burden Scale (MBCB) was conducted among Caregivers only. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Primary | Caregiver Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) | 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. | Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Secondary | Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 | 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. | One intervention and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. One intervention patient and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Secondary | Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 | 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. | One intervention patient and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Secondary | Patient Symptom Burden as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items | 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). | This outcomes measure pertains to patient-reported symptom burden. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Patient Symptom Burden Items as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items. | 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). | This outcomes measure pertains to patient-reported symptom burden. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Secondary | Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale | 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. | Measure conducted among patients only. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale | 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. | Measure conducted among patients only. One intervention participant and three usual care participants did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Secondary | Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale | 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. | This measure was conducted among patients only. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale | 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. | Conducted among patients only. One intervention participant and three usual care participants did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. | Posted | Mean | Standard Error | score on a scale | 16 weeks |
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| Secondary | Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument | 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 resource use (e.g. hospital admissions and days, emergency visits) was only captured among patients. | Posted | Mean | 95% Confidence Interval | days | Baseline |
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| Secondary | Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument | 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). | Patient resource use (e.g. hospital admissions and days, emergency visits) was only captured among patients. One intervention participant and one usual care participant did not provide sufficient responses to contribute to this outcomes measure at 16 weeks. | Posted | Mean | 95% Confidence Interval | days | 16 weeks |
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| Secondary | Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument | 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 resource use (e.g. hospital admissions and days, emergency visits) was only captured among patients. One participant in the Usual Care group did not respond to this survey item. | Posted | Mean | 95% Confidence Interval | visits | Baseline |
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| Secondary | Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument | 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). | Patient resource use (e.g. hospital admissions and days, emergency visits) was only captured among patients. One intervention participant did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. | Posted | Mean | 95% Confidence Interval | visits | 16 weeks |
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| 8 |
| 208 |
| 0 |
| 208 |
| 0 |
| 208 |
| EG001 | Usual HF Care for Patients | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. | 12 | 207 | 0 | 207 | 0 | 207 |
| EG002 | Active Intervention for Caregivers | Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes:
The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. | 0 | 82 | 0 | 82 | 0 | 82 |
| EG003 | Usual HF Care for Caregivers | Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. | 0 | 76 | 0 | 76 | 0 | 76 |
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