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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2019

Interventions

  • Behavioral: Gentle Stretching
    • 60 minutes fo gentle stretching twice weekly for 8 weeks

Arms, Groups and Cohorts

  • No Intervention: Educational Control Group
    • Education provided for optional use
  • Experimental: Gentle Stretching and Education
    • Gentle Stretching for 60 minutes twice weekly

Clinical Trial Outcome Measures

Primary Measures

  • Heart Failure Symptoms
    • Time Frame: 10 weeks
    • Heart Failure Somatic Perception Scale Questionnaire
  • Depression
    • Time Frame: 10 weeks
    • PROMIS-29 v1.0 subscale questionnaire
  • Quality of Life
    • Time Frame: 10 weeks
    • Kansas City Cardiomyopathy Questionnaire
  • Resilience
    • Time Frame: 10 weeks
    • Resilience Questionnaire
  • Self-Care
    • Time Frame: 10 weeks
    • Heart Failure Self-Care Index Questionnaire
  • Endurance
    • Time Frame: 10 weeks
    • 2 step test – step alternating knees upward for 2 minutes
  • strength
    • Time Frame: 10 weeks
    • arm curls and alternating sit to stand as many times as possible in 30 seconds
  • balance
    • Time Frame: 10 weeks
    • stand on 1 leg for as long as possible

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Virginia
  • Collaborator
    • University of Kentucky
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jill Howie Esquivel, PhD, Associate Professor – University of Virginia

References

Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

Ni H, Xu J. Recent Trends in Heart Failure-related Mortality: United States, 2000-2014. NCHS Data Brief. 2015 Dec;(231):1-8.

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.

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.

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. Review.

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.

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.

Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88.

Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ. 2000 Jan 8;320(7227):114-6. Review.

Martyn Hammersley. Challenging Relativism: The Problem of Assessment Criteria. Qual Inq. 2009 Jan 1;15(1):3-29.

Clive Seale. Quality in Qualitative Research. Qual Inq. 1999 Dec 1;5(4):465-78

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.