Heart Failure, Symptoms and Signs
Conditions
Keywords
Symptom Management, Technology
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.
Interventions
BEHAVIORALCoaching 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.
BEHAVIORALAutomated 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.
Sponsors
Emory University
National Heart, Lung, and Blood Institute (NHLBI)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of eligible patients recruited | Baseline (at the time of hospital discharge, pre-intervention) | Feasibility is determined by the number of eligible patients who enroll in the study. |
| Number of participants using the intervention | Up to Day 30 (post-intervention) | Feasibility is determined by the number of participants who complete the daily monitoring reports. |
| Days on Study | Up to Day 30 (post-intervention) | Feasibility is determined by the number of days that participants remain in the study. |
| Satisfaction with Phone Calls | Day 30 (post-intervention) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYoujeong Kang, PhD
Emory University
Outcome results
None listed