Symptom Care at Home Heart Failure Pilot Study

Heart Failure Clinical Trial

— SCHHF  

Official title:

Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04347759
• Other study ID #: 1K23HL148545-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 12, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Symptoms and Signs

Intervention

Other:
• Symptom Care at Home-Heart Failure
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. Based on symptom severity, intervention group will receive automated coaching messages. There will be a toll-free number for participants to call and a password to log into the system which will be stored on a secure and HIPPA-compliant sever. Calls can be personalized to allow the voice to greet the patient by name.

Locations

Country	Name	City	State
United States	Emory Health system	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom trajectories	Assess daily symptom scores from the beginning to the end of the symptom monitoring and SCH-HF system. The values are from 1(least symptom severity) to 10 (highest symptom severity). The higher score is the worse symptom.	over 30 days after hospital discharge
Secondary	Self-management behaviors Self-management behaviors Self-management behaviors	baseline and post-intervention assessments using the Self-Care of Heart Failure Index (v 7.2). The scale of self-care maintenance items is from 1 (never) to 5(always): the scale of 9 symptom perception questions is from 1 (never) to 5(always): the scale of 2 symptom perception questions is from 0 (no symptoms) to 5 (very quickly): the scale of 7 self-care management questions is from 1(not likely) to 5 (very likely):the scale of 1 self-care management question is from 0 (I did not do anything) to 5( very sure): The lower score is the better outcome.	In the beginning and at the end of the symptom monitoring and SCH-HF- Before first day monitoring symptoms and at the last day monitoring symptoms (at 30 day)- up to 30 days.