CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 573 enrolled
Drug / intervention
Behavioral Support +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02505425
NCT02505425N/ACompleted

Randomized Trial of ENABLE CHF-PC for Heart Failure Patients and Caregivers. (Comprehensive Heartcare For Patients and Caregivers)

University of Alabama at Birmingham·interventional·Posted Jul 22, 2015·Updated Jan 18, 2022

In Brief

A clinical study evaluating Behavioral Support and Usual HF Care for Heart Failure. Completed, enrolled 573 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 22, 2015
Enrollment StartNov 30, 2015
Primary CompletionOct 20, 2018
Study CompletionMay 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.9 years ago

Interventions

Behavioral Supportbehavioral

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.

Usual HF Carebehavioral

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