Symptom Care at Home Heart Failure Pilot Study (SCHHF)
Primary Purpose
Heart Failure, Symptoms and Signs
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symptom Care at Home-Heart Failure
Sponsored by
About this trial
This is an interventional other trial for Heart Failure focused on measuring Symptom Management, Technology
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 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.
Sites / Locations
- University Utah Health systemRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
System with coaching messages
Arm Description
A telephone-computer interface IVR system to report symtopms and to receive coaching messages based on symptom severity.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04347759
Brief Title
Symptom Care at Home Heart Failure Pilot Study
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Symptoms and Signs
Keywords
Symptom Management, Technology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
System with coaching messages
Arm Type
Other
Arm Description
A telephone-computer interface IVR system to report symtopms and to receive coaching messages based on symptom severity.
Intervention Type
Other
Intervention Name(s)
Symptom Care at Home-Heart Failure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Symptom trajectories
Description
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.
Time Frame
over 30 days after hospital discharge
Secondary Outcome Measure Information:
Title
Self-management behaviors Self-management behaviors Self-management behaviors
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youjeong Kang, PhD
Phone
2547177802
Email
youjeong.kang@nurs.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youjeong Kang, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Utah Health system
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
801-581-2121
12. IPD Sharing Statement
Learn more about this trial
Symptom Care at Home Heart Failure Pilot Study
We'll reach out to this number within 24 hrs