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

Emory University

Status: Enrolling

Conditions: Symptoms and Signs; Heart Failure

Treatments: Behavioral: Automated Daily Monitoring; Behavioral: Coaching Messages

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04347759

STUDY00007523

K23HL148545 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Symptom Care at Home with Coaching Messages

Experimental group

Description:

Participants randomized to automated daily monitoring and real-time self-management coaching.

Treatment:

Behavioral: Coaching Messages

Behavioral: Automated Daily Monitoring

Usual Care

Active Comparator group

Description:

Participants randomized to automated daily monitoring only.

Treatment:

Behavioral: Automated Daily Monitoring