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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
50
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.
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.
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory Clinic
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Utah Health
Salt Lake City, Utah, United States
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.
Time frame: Baseline (at the time of hospital discharge, pre-intervention), Day 30 (post-intervention)
Number of eligible patients recruited
Feasibility is determined by the number of eligible patients who enroll in the study.
Time frame: 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.
Time frame: Up to Day 30 (post-intervention)
Days on Study
Feasibility is determined by the number of days that participants remain in the study.
Time frame: 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.
Time frame: Day 30 (post-intervention)
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