Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-25 @ 10:24 AM
Study NCT ID:
NCT04120857
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2019-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
A Tele-Health Symptom Management Program for Patients With Heart Failure: Pall-Heart
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pall-Heart
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: