Clinical trial NCT02505425: ENABLE CHF-PC (Comprehensive Heartcare For Patients and Caregivers)
Official title: Randomized Trial of ENABLE CHF-PC for Heart Failure Patients and Caregivers. (Comprehensive Heartcare For Patients and Caregivers)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2015-07-22
Enrollment: 573
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: As described.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
timeFrame: Baseline
measure: Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
timeFrame: 16 weeks
measure: Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)
timeFrame: Baseline
measure: Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)
timeFrame: 16 weeks
measure: Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 16 weeks
measure: Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 16 weeks
measure: Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)
timeFrame: Baseline
measure: Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)
timeFrame: 16 weeks
measure: Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
timeFrame: Baseline
measure: Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
timeFrame: 16 weeks
measure: Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
timeFrame: Baseline
measure: Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
timeFrame: 16 weeks
measure: Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
timeFrame: Baseline
measure: Caregiver Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
timeFrame: 16 weeks
Secondary outcomes:
measure: Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
timeFrame: Baseline
measure: Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
timeFrame: 16 weeks
measure: Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
timeFrame: Baseline
measure: Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
timeFrame: 16 weeks
measure: Patient Symptom Burden as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items
timeFrame: Baseline
measure: Patient Symptom Burden Items as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items.
timeFrame: 16 weeks
measure: Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale
timeFrame: Baseline
measure: Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale
timeFrame: 16 weeks
measure: Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale
timeFrame: Baseline
measure: Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale
timeFrame: 16 weeks
measure: Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument
timeFrame: Baseline
measure: Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument
timeFrame: 16 weeks
measure: Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument
timeFrame: Baseline
measure: Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Veterans Affairs Medical Center (BVAMC)
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, School of Nursing, Dept. Acute, Chronic and Continuing Care
state: Alabama
Study officials:
affiliation: University of Alabama at Birmimgham, School of Nursing, Dept. Acute, Chronic & Continuing Care
name: Marie Bakitas, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.