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NCT04120857 · ClinicalTrials.gov registry record · NA
A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
A NA study of Heart Failure, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04120857: Completed NA study of Heart Failure, sponsored by University of Virginia.
NCT04120857 is a NA study of Heart Failure that has completed, run by University of Virginia. The registered enrollment target is 30 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04120857, a NA study of Heart Failure, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Heart failure is common in adults and is the most common hospital diagnosis in older adults. Patients with heart failure suffer numerous distressing symptoms daily. Although palliative care can improve suffering, rural-dwelling heart failure patients have poor access to specialized palliative care. The investigators propose to pilot test a tele-health palliative care intervention, PALL-HEART, in rural dwelling heart failure patients who live in Virginia and Kentucky. Study specific objectives are: Primary Aims: * AIM 1: Compare HF patients who participate in a home-delivered tablet-based HF health education and gentle stretching intervention, to a health education (HE) group on: a) HF symptoms (weight gain, breathlessness, fatigue), b) psychological symptoms (depression, diminished QOL, resilience, self-care, and heart rate variability), c) physical function (endurance, strength, balance), and d) health care utilization rates (ED visits, office visits, hospitalizations). * Hypothesis 1: HF symptoms (weight gain, breathlessness, fatigue), psychological symptoms (depression, diminished QOL, resilience, self-care), physical function (endurance, strength, balance) will improve in the intervention group. * Hypothesis 2: Health care utilization rates (ED visits, office visits, hospitalizations) will decrease in the intervention group. Secondary: * AIM 2: Acceptability - Acceptability of the intervention will be determined using: a) participation and satisfaction rates (participant logs), b) intervention retention rates, and c) barriers to participation (technology and participant motivation issues). * Hypothesis: Subjects in the intervention group will have \>80% participation and satisfaction rates and be willing to identify barriers to participation. acceptability of the intervention for future refinement and large scale testing.
Primary Outcome
This questionnaire measures symptoms of heart failure - The 18-item Somatic Perception Scale asks participants how much they are bothered by 18 symptoms of heart failure in the past week using 5 response options ranging from 0 (I did not have the symptom) to 5 (extremely bothersome). Scores are summed, with higher values indicating higher symptom burden. Scores range from 0-90 with higher values indicating higher symptom burden.
Conditions Studied
Interventions
- BEHAVIORAL Gentle Stretching
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2020-09-30 |
| Phase | NA |
What the finished NCT04120857 record still lists
NCT04120857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Gentle Stretching is the first listed.
NCT04120857 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04120857 about?
NCT04120857 is a clinical study titled "A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart". Heart failure is common in adults and is the most common hospital diagnosis in older adults. Patients with heart failure suffer numerous distressing symptoms daily. Although palliative care can improve suffering, rural-dwelling heart failure patients have poor access to specialized palliative care. ...
What is the current status of trial NCT04120857?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-06-01. Estimated completion is 2020-09-30.
What conditions does trial NCT04120857 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT04120857?
The interventions under investigation include: Gentle Stretching (BEHAVIORAL).
Who is sponsoring clinical trial NCT04120857?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04120857 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04120857's enrollment target sits among peer trials
30 322nd of 397 higher than 69 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure 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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