Clinical trial NCT04120857: A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
Official title: A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: stretching
exercise
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2019-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Heart Failure Somatic Perception Scale Questionnaire
timeFrame: 10 weeks
measure: PROMIS questionnaire
timeFrame: 10 weeks
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 10 weeks
measure: The Resilience Scale
timeFrame: 10 weeks
measure: Self-Care for Heart Failure Index Questionnaire (SCHFI)
timeFrame: 10 weeks
measure: Endurance
timeFrame: 10 weeks
measure: upper body strength - we will measure bicep strength by the number of hand weight lifts
timeFrame: 10 weeks
measure: lower body strength - we will measure quadricep strength by the number of times siting and standing in 30 seconds
timeFrame: 10 weeks
measure: balance
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
citation: Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
citation: Ni H, Xu J. Recent Trends in Heart Failure-related Mortality: United States, 2000-2014. NCHS Data Brief. 2015 Dec;(231):1-8.
citation: Zambroski CH, Moser DK, Bhat G, Ziegler C. Impact of symptom prevalence and symptom burden on quality of life in patients with heart failure. Eur J Cardiovasc Nurs. 2005 Sep;4(3):198-206. doi: 10.1016/j.ejcnurse.2005.03.010.
citation: Rogers JG, Patel CB, Mentz RJ, Granger BB, Steinhauser KE, Fiuzat M, Adams PA, Speck A, Johnson KS, Krishnamoorthy A, Yang H, Anstrom KJ, Dodson GC, Taylor DH Jr, Kirchner JL, Mark DB, O'Connor CM, Tulsky JA. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial. J Am Coll Cardiol. 2017 Jul 18;70(3):331-341. doi: 10.1016/j.jacc.2017.05.030.
citation: Braun LT, Grady KL, Kutner JS, Adler E, Berlinger N, Boss R, Butler J, Enguidanos S, Friebert S, Gardner TJ, Higgins P, Holloway R, Konig M, Meier D, Morrissey MB, Quest TE, Wiegand DL, Coombs-Lee B, Fitchett G, Gupta C, Roach WH Jr; American Heart Association Advocacy Coordinating Committee. Palliative Care and Cardiovascular Disease and Stroke: A Policy Statement From the American Heart Association/American Stroke Association. Circulation. 2016 Sep 13;134(11):e198-225. doi: 10.1161/CIR.0000000000000438. Epub 2016 Aug 8.
citation: Dracup K, Moser DK, Pelter MM, Nesbitt TS, Southard J, Paul SM, Robinson S, Cooper LS. Randomized, controlled trial to improve self-care in patients with heart failure living in rural areas. Circulation. 2014 Jul 15;130(3):256-64. doi: 10.1161/CIRCULATIONAHA.113.003542. Epub 2014 May 9.
citation: Donesky D, Selman L, McDermott K, Citron T, Howie-Esquivel J. Evaluation of the Feasibility of a Home-Based TeleYoga Intervention in Participants with Both Chronic Obstructive Pulmonary Disease and Heart Failure. J Altern Complement Med. 2017 Sep;23(9):713-721. doi: 10.1089/acm.2015.0279. Epub 2017 Jun 27.
citation: Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
citation: Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ. 2000 Jan 8;320(7227):114-6. doi: 10.1136/bmj.320.7227.114. No abstract available.
citation: Martyn Hammersley. Challenging Relativism: The Problem of Assessment Criteria. Qual Inq. 2009 Jan 1;15(1):3-29.
citation: Clive Seale. Quality in Qualitative Research. Qual Inq. 1999 Dec 1;5(4):465-78