NCT04347759

Symptom Care at Home-Heart Failure

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Heart Failure
• Symptoms and Signs

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-02-12
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2020-04-15
• Last updated: 2026-03-13

Locations

4 sites across 1 country: United States