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NCT02505425 · ClinicalTrials.gov registry record · NA
ENABLE CHF-PC (Comprehensive Heartcare For Patients and Caregivers)
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 573
- Enrollment target
NCT02505425: Completed NA study, sponsored by University of Alabama at Birmingham.
NCT02505425 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 573 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02505425, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 573 participants
- Enrollment target
Study 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.
Primary Outcome
Baseline patient-reported Quality of Life (QOL) was measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score, a heart failure-specific 23-item instrument. The KCCQ consists of 4 clinical domains: symptoms - frequency \& severity; Physical Limitation; Quality of Life and Social Limitation and captures the patient's perspective of heart failure. Clinical summary scores range from 0 to 100. Higher KCCQ scores indicate better perceived health status. KCCQ clinical summa
Interventions
- BEHAVIORAL Behavioral Support
- BEHAVIORAL Usual HF Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 573 participants |
| Start Date | 2015-11-30 |
| Est. Completion | 2019-05-10 |
| Phase | NA |
What the finished NCT02505425 record still lists
NCT02505425 is an interventional study that assigns participants to a tested intervention. The registered 573 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Behavioral Support is the first listed.
NCT02505425 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02505425 about?
NCT02505425 is a clinical study titled "ENABLE CHF-PC (Comprehensive Heartcare For Patients and Caregivers)". 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 acc...
What is the current status of trial NCT02505425?
This trial is currently completed. It is a NA study. The enrollment target is 573 participants. The study started on 2015-11-30. Estimated completion is 2019-05-10.
What interventions are being tested in trial NCT02505425?
The interventions under investigation include: Behavioral Support (BEHAVIORAL), Usual HF Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT02505425?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02505425's enrollment target sits among peer trials
573 179th of 2000 higher than 1,822 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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