Symptom Care at Home-Heart Failure (SCH-HF)

Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Symptoms and Signs
• Intervention / Treatment: Behavioral: Automated Daily Monitoring; Behavioral: Coaching Messages

Detailed Description

Keeping heart failure (HF) patients at home with a low symptom burden after hospital discharge is challenging. HF patients may suffer worsening symptoms over time without seeking medical advice leading to poor quality of life and readmission to the hospital. Evidence shows that delay in HF symptom recognition and poor self-management are associated with unplanned HF-related emergency department (ED) visits and rehospitalizations. Clinical trials aimed at preventing rehospitalization using telemonitoring of physical changes, such as daily weights, have shown limited utility.

Understanding patients' experiences of HF symptoms and engagement in appropriate self-management are key to maintaining disease stability. Cancer studies have shown that symptom burden can be effectively decreased using automated home monitoring and self-management coaching. A recent cancer study has demonstrated that patients receiving cancer chemotherapy achieved a 40% reduction in symptoms using Symptom Care at Home (SCH), a telephone-computer interface interactive voice response (IVR) system pairing patient-reported symptoms with automated real-time self-management coaching. While a few HF studies have used interventions that monitored symptoms, no studies have tested a system that monitors and provides real-time self-management coaching tailored to specific patient-reported outcomes (PRO). The objective of this study is to adapt the SCH system to HF and conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and preliminary efficacy of the Symptom Care at Home - Heart Failure (SCH-HF) system.

Participants are randomized to receive usual care consisting of automated daily monitoring, or to receive the intervention, which includes automated daily monitoring and real-time self-management coaching.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youjeong Kang, PhD; Phone Number: 254-717-7802; Email: youjeong.kang@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Hospital Midtown
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Completed
      • University of Utah Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symptom Care at Home with Coaching Messages; Participants randomized to automated daily monitoring and real-time self-management coaching.	Behavioral: Automated Daily Monitoring; 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.; Behavioral: Coaching Messages; 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.
Active Comparator: Usual Care; Participants randomized to automated daily monitoring only.	Behavioral: Automated Daily Monitoring; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of eligible patients recruited	Feasibility is determined by the number of eligible patients who enroll in the study.	Baseline (at the time of hospital discharge, pre-intervention)
Number of participants using the intervention	Feasibility is determined by the number of participants who complete the daily monitoring reports.	Up to Day 30 (post-intervention)
Days on Study	Feasibility is determined by the number of days that participants remain in the study.	Up to Day 30 (post-intervention)
Satisfaction with Phone Calls	Acceptability is assessed using a 10-point Likert scale asking participants how satisfied they were with the phone calls. Responses are given such that 10 means the participant was very satisfied and 1 means they were not satisfied at all.	Day 30 (post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Re-hospitalized	The re-hospitalization rate will be an exploratory endpoint between study arms.	Up to 30 days after hospital discharge

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Utah
• Investigators: Principal Investigator: Youjeong Kang, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Technology; Symptom Management
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Pathological Conditions, Signs and Symptoms; Heart Failure; Signs and Symptoms
• Other Study ID Numbers: STUDY00007523; K23HL148545 (U.S. NIH Grant/Contract); 2025P010357 (Other Identifier: Emory IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available for sharing with other researchers.
• IPD Sharing Time Frame: Data will be made available for sharing following publication of findings from this study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No