Clinical trial NCT04347759: Symptom Care at Home-Heart Failure
Official title: Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Symptoms and Signs
Keywords: Symptom Management
Technology
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Utah
First posted: 2020-04-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-Care of Heart Failure Index (SCHFI) Score
timeFrame: Baseline (at the time of hospital discharge, pre-intervention), Day 30 (post-intervention)
Secondary outcomes:
measure: Number of Participants Re-hospitalized
timeFrame: Up to 30 days after hospital discharge
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: Emory University
name: Youjeong Kang, PhD
role: PRINCIPAL_INVESTIGATOR
References: