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Symptom Care at Home-Heart Failure
NCT04347759 · Emory University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure
About this study
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.
Eligibility criteria
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 design
Enrollment target: 50 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-02-12
Estimated completion: 2026-04-30
Last updated: 2026-03-13
Interventions
Behavioral: Coaching MessagesBehavioral: Automated Daily Monitoring
Primary outcomes
- • Self-Care of Heart Failure Index (SCHFI) Score (Baseline (at the time of hospital discharge, pre-intervention), Day 30 (post-intervention))
Sponsor
Emory University · other
With: National Heart, Lung, and Blood Institute (NHLBI), University of Utah
Contacts & investigators
ContactYoujeong Kang, PhD · contact · youjeong.kang@emory.edu · 254-717-7802
InvestigatorYoujeong Kang, PhD · principal_investigator, Emory University
All locations (4)
Emory University Hospital MidtownRecruiting
Atlanta, Georgia, United States
Emory ClinicRecruiting
Atlanta, Georgia, United States
Emory University HospitalRecruiting
Atlanta, Georgia, United States
University of Utah HealthCompleted
Salt Lake City, Utah, United States