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

The University of Alabama at Birmingham

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Behavioral Support; Behavioral: Usual HF Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02505425

X140813007

Details and patient eligibility

About

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.

Full description

As described.

Enrollment: 573 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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573 participants in 2 patient groups

Active Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Behavioral Support

Usual HF Care

Active Comparator group

Description:

Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

Treatment:

Behavioral: Usual HF Care