Heart Failure Self-care Mobile Application to Reduce Readmissions Trial

Study Overview
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Brief Summary
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This is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. The investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone application that enhances self-care.

Official Title
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Heart Failure Self-care Mobile Application to Reduce Readmissions Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Mobile Health Technology Platform
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient admission for acute decompensated heart failure Left ventricular systolic or diastolic heart failure Owns a smartphone with a data plan Exclusion Criteria: Hospice or life expectancy less than 6 months Palliative inotrope use Heart transplant listed, or status post transplant Ventricular assist devise present, or awaiting placement Not being discharged to home Unable to provide consent or comply with the intervention Current enrollment in a remote monitoring/ telehealth program

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Consists of routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant. | Other: Usual care<br>* Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.<br>|
| Experimental: Application<br>Participants will be provided a special link to navigate to the online content and resources. | Other: Mobile Health Technology Platform<br>* When the participant navigates to the program, s/he will follow the directions on how to use the program, sign the terms of agreement, put in a password and begin the welcome page. The participant will receive daily prompts to complete brief questionnaires and review specialized content.<br>* Other names: Smartphone Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants readmitted within 30 days | 30-day readmission rate as determined by participant report or medical record query | 30 days post index discharge | 
| Percent of participants readmitted within 90 days | 90-day readmission rate as determined by participant report or medical record query | 90 days post index discharge | 
| Time to readmission | time to readmission | from the date of enrollment until the date of first documented admission or date of death from any cause, whichever comes first, assessed up to 90 days | 
| Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment | Quality of life, subjective level of function | 30 days post index discharge | 
| Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment | Quality of life, subjective level of function | 90 days post index discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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readmission, quality of life, self-care