Symptom Care at Home-Heart Failure
- Conditions
- Symptoms and SignsHeart Failure
- Interventions
- Other: Symptom Care at Home-Heart Failure
- Registration Number
- NCT04347759
- Lead Sponsor
- Emory University
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 81
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description System with coaching messages Symptom Care at Home-Heart Failure A telephone-computer interface IVR system to report symtopms and to receive coaching messages based on symptom severity.
- Primary Outcome Measures
Name Time Method Self-Care of Heart Failure Index (SCHFI) Score Baseline (at the time of hospital discharge, pre-intervention), Day 30 (post-intervention) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Re-hospitalized Up to 30 days after hospital discharge The re-hospitalization rate will be examined between study arms.
Trial Locations
- Locations (3)
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States