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

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

Interventions

BEHAVIORAL

Behavioral Support

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.

BEHAVIORAL

Usual HF Care

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

Sponsors & Collaborators

• US Department of Veterans Affairs

  collaborator FED

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Marie Bakitas, DNSc · University of Alabama at Birmimgham, School of Nursing, Dept. Acute, Chronic & Continuing Care

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2018-10-20

Completion

2019-05-10

Countries

• United States

Study Locations