A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
NCT ID: NCT04120857
Last Updated: 2020-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-06-01
2020-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Educational Control Group
Education provided for optional use
No interventions assigned to this group
Gentle Stretching and Education
Gentle Stretching for 60 minutes twice weekly
Gentle Stretching
60 minutes fo gentle stretching twice weekly for 8 weeks
Interventions
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Gentle Stretching
60 minutes fo gentle stretching twice weekly for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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University of Kentucky
OTHER
University of Virginia
OTHER
Responsible Party
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Jill Howie Esquivel, PhD
Associate Professor
Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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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.
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. doi: 10.1016/j.ejcnurse.2005.03.010.
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.
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. doi: 10.1177/1049732305276687.
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.
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
Other Identifiers
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21320
Identifier Type: -
Identifier Source: org_study_id