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

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID: NCT04120857
Run by: University of Virginia
People needed: 30
Starts: 2019-06-01
Expected to finish: 2020-09-30
Last updated by the study team: 2020-11-05

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Heart failure with reduced ejection fraction or Heart failure with preserved ejection fraction as seen by problem list in the EMR, is a patient in the heart failure clinic, or general cardiology clinic.
ability to read, write and understand English;
agree to participate and give informed consent;
19 years of age and older;
telephone access;
and NYHA class I-III with no changes in medications in 30 days (i.e. medical therapy is optimized).

You may not qualify if…

are pregnant and/or breast feeding (self-reported)
have a history of non-adherence with medications (as described by their provider or medical record);
have had a hospitalization within the last 3 months for HF;
have unstable angina; CABG, MI or biventricular pacemaker less than 6 weeks prior;
have orthopedic impediments to stretching exercise;
have severe COPD with a forced expiratory volume in one second less than 1 liter as measured by spirometry;
have severe stenotic valvular disease;
have a history of resuscitated sudden cardiac death without subsequent placement of an implantable cardioverter defibrillator;
exercise more than 3 times weekly; currently engage in yoga at least 1 time per week;
have cognitive impairment (as measured by the Mini-Cog)
are living in a nursing home
history of pulmonary arterial hypertension (PASP>60mmHg)
other serious life-limiting co-morbidity, e.g. end stage cancer
post-heart transplant (s/p OHT) or Left Ventricular Assist Device (LVAD)
New York Heart Association Functional Class IV

Where it is running

University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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