Symptom Care at Home Heart Failure Pilot Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, Symptoms and Signs

Intervention / Treatment
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* Other: Symptom Care at Home-Heart Failure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: System with coaching messages<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom Management, Technology