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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Mobile Applications; Self-Management
• Intervention / Treatment: Behavioral: App Group

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Texas Woman's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Non-App Group; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Texas Woman's University
• Investigators: Principal Investigator: Suh Jen Lin, PhD, PT, Texas Woman's University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 19985

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No