Heart FailureENABLE CHF PCNCT02505425

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

A study testing Behavioral Support and Usual HF Care in people with Heart Failure, run by University of Alabama at Birmingham at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Heart Failure
What is being tested?: Behavioral Support and Usual HF Care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 573 participants
Where: 2 sitesUnited States
Study dates: 30 Nov 2015to 10 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to read and understand English
NYHF III/IV heart failure (physician-determined)

Who cannot join

Dementia or significant confusion (Callahan 6-Item Cognitive Screening score ≤ 3)
DSM-IV Axis I diagnosis (e.g. schizophrenia, bipolar disorder, or active substance use disorder)
Patients will not be excluded if they do not identify a caregiver
Uncorrectable hearing loss.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Birmingham Veterans Affairs Medical Center (BVAMC)
Birmingham, Alabama, 35233
University of Alabama at Birmingham, School of Nursing, Dept. Acute, Chronic and Continuing Care
Birmingham, Alabama, 35233

Other trials in United States

About this study

Official title: Randomized Trial of ENABLE CHF-PC for Heart Failure Patients and Caregivers. (Comprehensive Heartcare For Patients and Caregivers)

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.

Read the detailed description

As described.

Conditions: Heart Failure
Being tested: Behavioral Support, Usual HF Care
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral SupportBehavioural
Also called ENABLE CHF-PC
ENABLE CHF-PC includes:
1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.
2. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.
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.
Usual HF CareBehavioural
Also called Usual Heart Failure Care
Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

Study groups in NCT02505425
Study group	Role	What they receive
Active Intervention	Experimental	Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Receives: Behavioral: Behavioral Support
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. Receives: Behavioral: Usual HF Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks

Secondary outcomes (14)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 201510 May 2019

First posted22 Jul 2015 (estimated)
Study start30 Nov 2015
Primary completion20 Oct 2018
Study completion10 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 573 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02505425
Sponsor's protocol ID: X140813007
Acronym: ENABLE CHF PC
Status last verified: Jan 2022
First submitted: 8 Jul 2015
Last updated: 18 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: At this time, the study plans to share data in aggregate and as overall results only.

Publications

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.
PubMed 33556493
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.
PubMed 33258422
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.
PubMed 32730613
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.
PubMed 32282044
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.
PubMed 30081933

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of ENABLE CHF-PC for Heart Failure Patients and Caregivers. (Comprehensive Heartcare For Patients and Caregivers)
ClinicalTrials.gov ID: NCT02505425
Acronym / sponsor ID: ENABLE CHF PC / X140813007
Conditions: Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 573 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: US Department of Veterans Affairs
Study start: 30 Nov 2015 (actual)
Primary completion: 20 Oct 2018 (actual)
Study completion: 10 May 2019 (actual)
First posted: 22 Jul 2015 (estimated)
Results: Posted 11 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Specific Aims and Hypotheses:

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.

Detailed description

As described.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Active Intervention	Experimental	Behavioral: Behavioral SupportBehavioral: behavioral support Usual HF Care + ENABLE CHF-PC
Usual HF Care	Active comparator	Behavioral: Usual HF CareUsual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Able to read and understand English
NYHF III/IV heart failure (physician-determined)

Key exclusion criteria (4 listed)

Dementia or significant confusion (Callahan 6-Item Cognitive Screening score ≤ 3)
DSM-IV Axis I diagnosis (e.g. schizophrenia, bipolar disorder, or active substance use disorder)
Patients will not be excluded if they do not identify a caregiver
Uncorrectable hearing loss.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Behavioral SupportAlso: ENABLE CHF-PCENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. 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.	Behavioural	Active Intervention
Usual HF CareAlso: Usual Heart Failure CareUsual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.	Behavioural	Usual HF Care

Primary outcome

Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Time frame: Baseline
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 Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
Time frame: 16 weeks
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.
Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)
Time frame: Baseline
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 Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)
Time frame: 16 weeks
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.
Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
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.
Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)
Time frame: 16 weeks
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.
Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
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 & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)
Time frame: 16 weeks
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.
Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)
Time frame: Baseline
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 Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)
Time frame: 16 weeks
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.
Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
Time frame: Baseline
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 Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
Time frame: 16 weeks
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.
Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
Time frame: Baseline
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 Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
Time frame: 16 weeks
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.
Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
Time frame: Baseline
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 Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
Time frame: 16 weeks
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.

14 secondary outcomes

Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
Time frame: Baseline
Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
Time frame: 16 weeks
Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
Time frame: Baseline
Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
Time frame: 16 weeks
Patient Symptom Burden as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items
Time frame: Baseline
Patient Symptom Burden Items as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items.
Time frame: 16 weeks
Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale
Time frame: Baseline
Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale
Time frame: 16 weeks
Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale
Time frame: Baseline
Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale
Time frame: 16 weeks
Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument
Time frame: Baseline
Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument
Time frame: 16 weeks
Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument
Time frame: Baseline
Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument
Time frame: 16 weeks

Results and safety

Results posted to the registry on 11 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Intervention for Patients	208	120
Usual HF Care for Patients	207	125
Active Intervention for Caregivers	82	32
Usual HF Care for Caregivers	76	50

Primary outcome: Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Active Intervention for Patients n = 208	Usual HF Care for Patients n = 207	Active Intervention for Caregivers n = 0	Usual HF Care for Caregivers n = 0
Value	54.2 (20.5)	51.1 (21.5)	–	–

Population analysed: This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure.

Primary outcome: Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score

Time frame: 16 weeks. Mean (Standard Error). Unit: score on a scale

Measure	Active Intervention for Patients n = 120	Usual HF Care for Patients n = 125	Active Intervention for Caregivers n = 0	Usual HF Care for Caregivers n = 0
Value	59.7 (1.8)	54.8 (1.8)	–	–

Population analysed: This measure pertains to Patient Quality of Life (QOL) using the KCCQ. Caregiver QOL was analyzed using a different measure.

Primary outcome: Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Active Intervention for Patients n = 208	Usual HF Care for Patients n = 207	Active Intervention for Caregivers n = 0	Usual HF Care for Caregivers n = 0
Value	36.8 (9.3)	36.1 (9.7)	–	–

Population analysed: This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure.

Primary outcome: Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)

Time frame: 16 weeks. Mean (Standard Error). Unit: score on a scale

Measure	Active Intervention for Patients n = 119	Usual HF Care for Patients n = 123	Active Intervention for Caregivers n = 0	Usual HF Care for Caregivers n = 0
Value	38.5 (0.8)	36.8 (0.8)	–	–

Population analysed: 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.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 41 months. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Intervention for Patients	0 of 208 (0%)	0 of 208 (0%)	8 of 208
Usual HF Care for Patients	0 of 207 (0%)	0 of 207 (0%)	12 of 207
Active Intervention for Caregivers	0 of 82 (0%)	0 of 82 (0%)	0 of 82
Usual HF Care for Caregivers	0 of 76 (0%)	0 of 76 (0%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33556493Wells 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.
Derived from this study: PubMed 33258422Stockdill 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.
Derived from this study: PubMed 32730613Bakitas 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.
Derived from this study: PubMed 32282044Dionne-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.
Derived from this study: PubMed 30081933Wells 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.
Individual participant dataSharing planned: No. At this time, the study plans to share data in aggregate and as overall results only.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marie Bakitas, DNSc principal investigator

University of Alabama at Birmimgham, School of Nursing, Dept. Acute, Chronic & Continuing Care

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Support and Usual HF Care in people with Heart Failure, run by University of Alabama at Birmingham at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (time frame: Baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02505425, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.