Heart Failure Clinical Trial

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.

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Full Description

As described.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

573

Study ID:

NCT02505425

Recruitment Status:

Completed

Sponsor:

University of Alabama at Birmingham

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There is 1 Location for this study

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Birmingham Veterans Affairs Medical Center (BVAMC)
Birmingham Alabama, 35233, United States
University of Alabama at Birmingham, School of Nursing, Dept. Acute, Chronic and Continuing Care
Birmingham Alabama, 35233, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

573

Study ID:

NCT02505425

Recruitment Status:

Completed

Sponsor:


University of Alabama at Birmingham

How clear is this clinincal trial information?

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