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

NCT02505425 | Completed Results DMC

• 1 other identifier: X140813007
• Study Type: interventional
• Target: 573
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (16)

• 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.

  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

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 PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10

  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 MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10

  16 weeks

• Patient Symptom Burden as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items

  Baseline

Study Arms (2)

Active Intervention

EXPERIMENTAL

Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC

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.

Behavioral: Usual HF Care

Interventions

Behavioral Support BEHAVIORAL

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.

Also known as: ENABLE CHF-PC

Active Intervention

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.

Also known as: Usual Heart Failure Care

Usual HF Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• US Department of Veterans Affairs: collaborator

Study Sites (2)

Birmingham Veterans Affairs Medical Center (BVAMC)

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham, School of Nursing, Dept. Acute, Chronic and Continuing Care

Birmingham, Alabama, 35233, United States

Location

Related Publications (5)

• 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.

  PMID: 33556493 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.

  PMID: 33258422 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.

  PMID: 32730613 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.

  PMID: 32282044 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.

  PMID: 30081933 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Marie A. Bakitas, DNSc, NP-C, FAAN
• Organization: The University of Alabama at Birmingham, School of Nursing

mbakitas@uab.edu

(205) 934-5277

Study Officials

• Marie Bakitas, DNSc

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 22, 2015
• Study Start: November 30, 2015
• Primary Completion: October 20, 2018
• Study Completion: May 10, 2019
• Last Updated: January 18, 2022
• Results First Posted: February 11, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)