SCHHF: Symptom Care at Home Heart Failure Pilot Study

Sponsor
University of Utah (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04347759
Collaborator
(none)
40
Enrollment
1
Arm
40.5
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Symptom Care at Home-Heart Failure
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Symptom Care at Home-Heart Failure: Developing and Piloting a Symptom Monitoring and Self-Management Coaching System for Patients With Heart Failure
Anticipated Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2025

Arms and Interventions

ArmIntervention/Treatment
Other: System with coaching messages

A telephone-computer interface IVR system to report symtopms and to receive coaching messages based on symptom severity.

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.

Outcome Measures

Primary Outcome Measures

  1. Symptom trajectories [over 30 days after hospital discharge]

    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.

Secondary Outcome Measures

  1. Self-management behaviors Self-management behaviors Self-management behaviors [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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 II or III

  • ability to read, understand, and speak in English

  • will be discharged home without any post-acute care services

  • history of prior rehospitalization

  • the routine use of diuretics at least daily

  • have daily access to any type of telephone

  • NYHA class II or III was chosen to reflect previous research in which the majority of participants were in NYHA class II (slight limitation of physical activity) and III (marked limitation of physical activity).

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Utah

Investigators

  • Principal Investigator: Youjeong Kang, PhD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Youjeong Kang, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier:
NCT04347759
Other Study ID Numbers:
  • 1K23HL148545-01A1
First Posted:
Apr 15, 2020
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Youjeong Kang, Assistant Professor, University of Utah
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021