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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gentle Stretching
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring stretching, exercise

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Educational Control Group

Gentle Stretching and Education

Arm Description

Education provided for optional use

Gentle Stretching for 60 minutes twice weekly

Outcomes

Primary Outcome Measures

Heart Failure Somatic Perception Scale Questionnaire
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
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)
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
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)
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
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
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
participants are instructed to sit and then to stand as many times as possible in 30 seconds
balance
stand on 1 leg for as long as possible

Secondary Outcome Measures

Full Information

First Posted
September 24, 2019
Last Updated
November 3, 2020
Sponsor
University of Virginia
Collaborators
University of Kentucky
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1. Study Identification

Unique Protocol Identification Number
NCT04120857
Brief Title
A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
Acronym
Pall-Heart
Official Title
A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
University of Kentucky

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
stretching, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational Control Group
Arm Type
No Intervention
Arm Description
Education provided for optional use
Arm Title
Gentle Stretching and Education
Arm Type
Experimental
Arm Description
Gentle Stretching for 60 minutes twice weekly
Intervention Type
Behavioral
Intervention Name(s)
Gentle Stretching
Other Intervention Name(s)
Exercise
Intervention Description
60 minutes fo gentle stretching twice weekly for 8 weeks
Primary Outcome Measure Information:
Title
Heart Failure Somatic Perception Scale Questionnaire
Description
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.
Time Frame
10 weeks
Title
PROMIS questionnaire
Description
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.
Time Frame
10 weeks
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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.
Time Frame
10 weeks
Title
The Resilience Scale
Description
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.
Time Frame
10 weeks
Title
Self-Care for Heart Failure Index Questionnaire (SCHFI)
Description
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.
Time Frame
10 weeks
Title
Endurance
Description
2 step test - step alternating knees upward for 2 minutes
Time Frame
10 weeks
Title
upper body strength - we will measure bicep strength by the number of hand weight lifts
Description
participants are instructed to perform as many arm curls as possible for 30 seconds
Time Frame
10 weeks
Title
lower body strength - we will measure quadricep strength by the number of times siting and standing in 30 seconds
Description
participants are instructed to sit and then to stand as many times as possible in 30 seconds
Time Frame
10 weeks
Title
balance
Description
stand on 1 leg for as long as possible
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with investigators who request the dataset. No individual personal or HIPPA identifiers will be shared.
IPD Sharing Time Frame
when data are analyzed and for 5 years.
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A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart

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