Symptom Care at Home-Heart Failure
SCH-HF
3 other identifiers
interventional
50
1 country
4
Brief Summary
This project aims to adapt a computer-interface telephonic interactive voice response system that monitors symptoms and provides real-time, self-management coaching messages based on heart failure patient-reported outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Feb 2023
Typical duration for not_applicable heart-failure
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Start
First participant enrolled
February 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedMarch 13, 2026
February 1, 2026
3.2 years
April 1, 2020
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-Care of Heart Failure Index (SCHFI) Score
The Self-Care of Heart Failure Index, version 7.2, is a 29-item instrument with separate scales assessing self-care maintenance, symptom perception, and self-care management. Responses to items are given on a 5-point scale. Scores for each of the three scales are summed and standardized with scores ranging from 0 to 100. Higher scores indicate better self-care, with scores of 70 or higher indicating adequate levels of heart failure self-care.
Baseline (at the time of hospital discharge, pre-intervention), Day 30 (post-intervention)
Secondary Outcomes (4)
Number of eligible patients recruited
Baseline (at the time of hospital discharge, pre-intervention)
Number of participants using the intervention
Up to Day 30 (post-intervention)
Days on Study
Up to Day 30 (post-intervention)
Satisfaction with Phone Calls
Day 30 (post-intervention)
Other Outcomes (1)
Number of Participants Re-hospitalized
Up to 30 days after hospital discharge
Study Arms (2)
Symptom Care at Home with Coaching Messages
EXPERIMENTALParticipants randomized to automated daily monitoring and real-time self-management coaching.
Usual Care
ACTIVE COMPARATORParticipants randomized to automated daily monitoring only.
Interventions
Participants receive real-time self-management coaching messages based on the severity of their symptoms. When participants call, the IVR system will ask them about each of the selected symptoms, and the patient will report symptom presence and severity numerically with the touch-tone keypad.
Participants report daily symptoms and symptom severity. There are three categories of severity based on a numeric scale of 1 to 3 for mild symptoms, 4 to 7 for moderate symptoms, and 8 to 10 for severe symptoms.
Eligibility Criteria
You may qualify if:
- Medical diagnosis of heart failure
- New York Heart Association (NYHA) Classification of the Stages of Heart Failure Class I - IV
- Ability to read, understand, and speak in English
- Will be discharged home
- Has daily access to any type of telephone
You may not qualify if:
- A score of 0 or 1-2 with an abnormally drawn clock on the Mini-Cog
- Discharged home on hospice care
- End-stage renal failure
- Wait list for heart transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Utahcollaborator
Study Sites (4)
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory Clinic
Atlanta, Georgia, 30322, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Utah Health
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youjeong Kang, PhD
Emory University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 15, 2020
Study Start
February 12, 2023
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
March 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be made available for sharing following publication of findings from this study.
- Access Criteria
- Researchers who want to share de-identified data from this study must complete a data use agreement. Those wanting to share data from this study should contact Dr. Kang at youjeong.kang@emory.edu.
De-identified data will be made available for sharing with other researchers.