CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Gentle Stretchingbehavioral
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/NCT04120857
NCT04120857N/ACompleted

A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart

University of Virginia·interventional·Posted Oct 9, 2019·Updated Nov 5, 2020

In Brief

A clinical study evaluating Gentle Stretching for Heart Failure. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 9, 2019
Enrollment StartJun 1, 2019
Primary CompletionSep 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.7 years ago

Interventions

Gentle Stretchingbehavioral

60 minutes fo gentle stretching twice weekly for 8 weeks