A Self-care Mobile Health App in Individuals With Heart Failure

Study Overview
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Brief Summary
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This study was designed to determine the potential benefits that individuals with heart failure (HF) could experience from using a mobile application.

Detailed Description
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The mobile application is called the Heart Failure Health Storylines (HFHS). The potential benefits will be examined by determining the changes in physical activity and quality of life of the participants, who will use the application and compare the results with the participants, who will not use the application.

Official Title
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Usability and Effectiveness of a Self-care Mobile Health App in Individuals With Heart Failure

Conditions
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Self-Management, Mobile Applications, Heart Failure

Intervention / Treatment
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* Behavioral: App Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with chronic heart failure, class I - III based on New York Heart Association (NYHA) scale Walking independently with/without an assistive device Exclusion Criteria: The participant will be excluded if one or more of the following is present Cognitive impairment (< 26 on Montreal Cognitive Assessment). Uncorrected vision Hearing problems Neurological disorders. Cannot speak and read the English language, Not owning a smart cell phone with internet access.

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 |
| --- | --- |
| No Intervention: Non-App Group<br>The participants will be instructed to continue their daily routine, track their daily steps with a pedometer, and record their daily steps on the Activity Log paper form. | |
| Experimental: App Group<br>The participants will be trained how to use the mobile application (Heart Failure Health Storyline (HFHS)) to track their health status, physical activity, manage their medications schedule, and explore the other features that the application has. Additionally, they will receive a pedometer to track their daily steps and record their data on the mobile application. | Behavioral: App Group<br>* The participants will be educated to use the HFHS application to monitor their daily vital signs (HR, BP, body weight), physical activity, and medications for 4 weeks. The research team will monitor their data entry remotely via the HFHS App. The team will text the participant via the App if one or more of following conditions is noted: The vital signs show undesired readings The records on the HFHS App show that the participant did not take the medications as the schedule says In addition, the team will call the participant 3 days later to follow up regarding the participant's action towards the text message that the team sent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Experience | The Quality of Experience (QoE) survey will be used to measure the quality of experience in using the mobile application | Change from baseline to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life for Individuals with Heart Failure | 36-Item Short-Form Health Survey (SF-36 version 1.0) | Change from baseline to 4 weeks | 
| Quality of Life for Individuals with HF | Minnesota Living with Heart Failure (MLHF) questionnaire | Change from baseline to 4 weeks | 
| Physical Activity will be indicated by daily step counts | Physical activity will be assessed with a pedometer | Change from baseline to 4 weeks |