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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04120857
The ClinicalTrials.gov registry entry for NCT04120857 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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