N/A N=573 Randomized Treatment

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

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT02505425 ↗

Enrolled (actual)

573

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score — 54.2; 51.1 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Behavioral Support (Behavioral); Usual HF Care (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score	59.7; 54.8	—
PRIMARY Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score	59.7; 54.8	—
PRIMARY Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)	38.5; 36.8	—
PRIMARY Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)	38.5; 36.8	—
PRIMARY Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)	6.6; 7.1; 3.8; 4.2	—
PRIMARY Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)	6.6; 7.1; 3.8; 4.2	—
PRIMARY Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)	4.9; 5.6; 4.5; 4.4	—
PRIMARY Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)	4.9; 5.6; 4.5; 4.4	—
PRIMARY Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)	66.9; 63.9	—
PRIMARY Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)	66.9; 63.9	—
PRIMARY Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)	20.2; 19.7	—
PRIMARY Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)	20.2; 19.7	—
PRIMARY Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)	11.1; 11.6	—
PRIMARY Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)	11.1; 11.6	—
PRIMARY Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)	12.3; 12.3	—
PRIMARY Caregiver Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)	11.7; 12.2	—
SECONDARY Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10	39.4; 38.8; 46.9; 48.0	—
SECONDARY Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10	39.4; 38.8; 46.9; 48.0	—
SECONDARY Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10	45.9; 44.7; 47.7; 48.2	—
SECONDARY Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10	45.9; 44.7; 47.7; 48.2	—
SECONDARY Patient Symptom Burden as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items	52.2; 50.9	—
SECONDARY Patient Symptom Burden Items as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items.	59.6; 55.3	—
SECONDARY Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale	45.8; 47.4	—
SECONDARY Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale	45.8; 47.4	—
SECONDARY Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale	54.3; 57.7	—
SECONDARY Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale	54.3; 57.7	—
SECONDARY Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument	1.51; 1.29	—
SECONDARY Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument	1.51; 1.29	—
SECONDARY Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument	0.17; 0.19	—
SECONDARY Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument	0.17; 0.19	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02505425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.