Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure
概览
- 阶段
- 不适用
- 干预措施
- Coaching Messages
- 疾病 / 适应症
- Heart Failure
- 发起方
- Emory University
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Self-Care of Heart Failure Index (SCHFI) Score
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Symptom Care at Home with Coaching Messages
Participants randomized to automated daily monitoring and real-time self-management coaching.
干预措施: Coaching Messages
Symptom Care at Home with Coaching Messages
Participants randomized to automated daily monitoring and real-time self-management coaching.
干预措施: Automated Daily Monitoring
Usual Care
Participants randomized to automated daily monitoring only.
干预措施: Automated Daily Monitoring
结局指标
主要结局
Self-Care of Heart Failure Index (SCHFI) Score
时间窗: 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.
次要结局
- Number of eligible patients recruited(Baseline (at the time of hospital discharge, pre-intervention))
- Number of participants using the intervention(Up to Day 30 (post-intervention))
- Days on Study(Up to Day 30 (post-intervention))
- Satisfaction with Phone Calls(Day 30 (post-intervention))