Heart FailureSCH-HFNCT04347759
Symptom Care at Home-Heart Failure
A study testing Coaching Messages and Automated Daily Monitoring in people with Heart Failure and Symptoms and Signs, run by Emory University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Symptoms and Signs
- What is being tested?
- Coaching Messages and Automated Daily Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Feb 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory Clinic
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
University of Utah Health
Salt Lake City, Utah, 84112
About this study
Official title: Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure
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.
Read the 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.
- Conditions
- Heart Failure, Symptoms and Signs
- Being tested
- Coaching Messages, Automated Daily Monitoring
- Keywords
- Symptom Management, Technology
- Medical subject headings
- Heart Failure, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching MessagesBehavioural
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.
Automated Daily MonitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Symptom Care at Home with Coaching Messages | Experimental | Participants randomized to automated daily monitoring and real-time self-management coaching. Receives: Behavioral: Coaching Messages; Behavioral: Automated Daily Monitoring |
| Usual Care | Active comparator | Participants randomized to automated daily monitoring only. Receives: Behavioral: Automated Daily Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at the time of hospital discharge, pre-intervention), Day 30 (post-intervention)
Secondary outcomes (4)
Number of eligible patients recruited
Feasibility is determined by the number of eligible patients who enroll in the study.
Measured: 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.
Measured: Up to Day 30 (post-intervention)
Days on Study
Feasibility is determined by the number of days that participants remain in the study.
Measured: 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.
Measured: Day 30 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start12 Feb 2023
- Primary completion30 Mar 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Utah
- Responsible party
- Principal investigator, Youjeong Kang, Emory University
- Investigators
- Youjeong Kang, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347759
- Sponsor's protocol ID
- STUDY00007523
- Other IDs
- K23HL148545, 2025P010357
- Acronym
- SCH-HF
- Status last verified
- May 2026
- First submitted
- 1 Apr 2020
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04347759
- Acronym / sponsor ID
- SCH-HF / STUDY00007523
- Conditions
- Heart Failure, Symptoms and Signs
- Keywords
- Symptom Management, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Utah
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom Care at Home with Coaching Messages | Experimental | Behavioral: Coaching Messages, Behavioral: Automated Daily MonitoringParticipants randomized to automated daily monitoring and real-time self-management coaching. |
| Usual Care | Active comparator | Behavioral: Automated Daily MonitoringParticipants randomized to automated daily monitoring only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching MessagesParticipants 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. | Behavioural | Symptom Care at Home with Coaching Messages |
| Automated Daily MonitoringParticipants 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. | Behavioural | Symptom Care at Home with Coaching Messages, Usual Care |
Primary outcome
Self-Care of Heart Failure Index (SCHFI) Score
Time frame: 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.
4 secondary outcomes
Number of eligible patients recruited
Time frame: Baseline (at the time of hospital discharge, pre-intervention)
Number of participants using the intervention
Time frame: Up to Day 30 (post-intervention)
Days on Study
Time frame: Up to Day 30 (post-intervention)
Satisfaction with Phone Calls
Time frame: Day 30 (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be made available for sharing with other researchers.
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youjeong Kang, PhD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching Messages and Automated Daily Monitoring in people with Heart Failure and Symptoms and Signs, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Care of Heart Failure Index (SCHFI) Score (time frame: Baseline (at the time of hospital discharge, pre-intervention), Day 30 (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.