Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-02-12
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Symptom Care at Home with Coaching Messages
Participants randomized to automated daily monitoring and real-time self-management coaching.
Coaching 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 touchtone keypad.
Automated 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.
Usual Care
Participants randomized to automated daily monitoring only.
Automated 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.
Interventions
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Coaching 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 touchtone keypad.
Automated 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Discharged home on hospice care
* End-stage renal failure
* Wait list for heart transplant
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Utah
OTHER
Emory University
OTHER
Responsible Party
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Youjeong Kang
Assistant Professor
Principal Investigators
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Youjeong Kang, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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STUDY00007523
Identifier Type: -
Identifier Source: org_study_id
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