Heart Failure Clinical Trial

Symptom Care at Home Heart Failure Pilot Study

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. This system has the strong potential to be widely disseminated into clinical practice leading to improved patient outcomes through better self-management behaviors.

View Full Description

Full Description

Keeping heart failure (HF) patients at home with a low symptom burden after hospital discharge is challenging. Evidence shows that delay in HF symptom recognition and poor self-management are associated with unplanned emergency department visits and rehospitalizations. Clinical trials aimed at preventing rehospitalization using telemonitoring have shown limited utility suggesting that monitoring physical changes alone may not be sufficient to maintain stability of HF patients at home. A recent cancer study has demonstrated that patients receiving cancer chemotherapy achieved a 40% reduction in symptoms using Symptom Care at Home (SCH), a computer-interface telephonic interactive voice response 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 pilot an adaption of the SCH system to HF resulting in preliminary data to support a fully-powered randomized control trial to test an adapted SCH-HF system that could be widely disseminated. Specific Aims over two-parts are: Aim 1] Tailor the real-time self-management coaching system to integrate HF symptom monitoring and self-management coaching into the SCH-HF system; and Aim 2] Conduct a pilot randomized controlled trial (RCT) to assess the feasibility, acceptability, and preliminary efficacy of the SCH-HF system. This study is significant because it expands our understanding into HF symptom monitoring and management using PRO in the home setting. The proposal is innovative because it integrates HF clinician and patient perspectives to develop a daily home monitoring and real-time self-management coaching system.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

ICD-9-coded (402.01; 402.11; 402.91; 404.01; 404.03; 404.13; 404.91; 404.93; or 428.XX) or ICD-10-coded (150.1-150.9) medical diagnosis of HF
New York Heart Association (NYHA) class I - IV
ability to read, understand, and speak in English
will be discharged home
have 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:End-stage renal failure patients will be excluded because they receive clinical interaction with providers a few times per week while they are on hemodialysis.
Wait list for transplant

Study is for people with:

Heart Failure

Estimated Enrollment:

72

Study ID:

NCT04347759

Recruitment Status:

Active, not recruiting

Sponsor:

University of Utah

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Emory Health system
Atlanta Georgia, 30322, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

72

Study ID:

NCT04347759

Recruitment Status:

Active, not recruiting

Sponsor:


University of Utah

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.