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: June 30, 2020

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 Somatic Perception Scale Questionnaire
    • Time Frame: 10 weeks
    • This questionnaire measures symptoms of heart failure – The 18-item Somatic Perception Scale asks participants how much they are bothered by 18 symptoms of heart failure in the past week using 5 response options ranging from 0 (I did not have the symptom) to 5 (extremely bothersome). Scores are summed, with higher values indicating higher symptom burden. Scores range from 0-90 with higher values indicating higher symptom burden.
  • PROMIS questionnaire
    • Time Frame: 10 weeks
    • This questionnaire screens for symptoms of depression. The 8-item questionnaire assesses self-reported negative mood (sadness, guilt), views of self (self- criticism, worthlessness), and social cognition (loneliness, interpersonal alienation) in the past week. The questionnaire uses 5 response options ranging from 0 (never) to 5 (always). Scores are summed, with higher values indicating higher risk for depression. The total raw score is converted into a T-score. The T-score rescales the raw score into a standardized score. The final score is a standardized score with a mean of 50 and a standard deviation of 10.
  • Kansas City Cardiomyopathy Questionnaire (KCCQ)
    • Time Frame: 10 weeks
    • This questionnaire measures quality of life in people with heart failure. This questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Overall scores are transformed to a range of 0-100, in which higher scores reflect better health status. There are summary scores within the KCCQ and the overall summary score is created by the mean of Physical Limitation Score, Total Symptom Score, Quality of Life Score, and Social Limitation Score.
  • The Resilience Scale
    • Time Frame: 10 weeks
    • The Resilience Scale is a 25-item administered questionnaire that measures an individual’s ability to adapt over time to stressors in life. Scores on the summated scale range from 25 to 175, with higher scores indicating higher resilience. All of the items are positively worded. Items are measured on a 7-point scale from 1(strongly disagree) to 7 (strongly agree). Responses are summed to produce a total score where a higher score indicates higher resilience.
  • Self-Care for Heart Failure Index Questionnaire (SCHFI)
    • Time Frame: 10 weeks
    • The Self-Care for Heart Failure Index Questionnaire (SCHFI) is a 39-item measure of heart failure self-care. The items range from never (1) to always (5). There are 3 subscales: maintenance scale, symptom perception, confidence scale, and management scale. All of the scales are scored in the same way and a total score is not computed. Separate scores for each scale are computed separately. In general, to standardize a scale score, 1) determine the maximum possible scale score, 2) subtract the number of items from the possible score, and 3) divide 100 by that result to identify a constant for that scale. To score the scale, sum item responses, subtract the number of items answered, and multiply by the constant.The higher the score, the greater the ability to care for heart failure symptoms within each subscale.
  • Endurance
    • Time Frame: 10 weeks
    • 2 step test – step alternating knees upward for 2 minutes
  • upper body strength – we will measure bicep strength by the number of hand weight lifts
    • Time Frame: 10 weeks
    • participants are instructed to perform as many arm curls as possible for 30 seconds
  • lower body strength – we will measure quadricep strength by the number of times siting and standing in 30 seconds
    • Time Frame: 10 weeks
    • participants are instructed to sit and then 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

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