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

Not Applicable

Completed

• Conditions: Self-Management; Mobile Applications; Heart Failure
• Interventions: Behavioral: App Group

• Registration Number: NCT03509506
• Lead Sponsor: Texas Woman's University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-26
• Study Start: 2018-05-01
• Primary Completion: 2020-07-15
• Study Completion: 2021-02-05
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-22
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App Group	App Group	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.

Primary Outcome Measures

Name	Time	Method
Quality of Experience	Change from baseline to 4 weeks	The Quality of Experience (QoE) survey will be used to measure the quality of experience in using the mobile application

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Texas Woman's University; 🇺🇸 Dallas, Texas, United States