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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509506
• Other study ID #: 19985
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: February 5, 2021

Study information

• Verified date: April 2022
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 5, 2021
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Mobile Applications
• Self-Management

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Woman's University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of Life for Individuals with HF	Minnesota Living with Heart Failure (MLHF) questionnaire	Change from baseline to 4 weeks
Secondary	Physical Activity will be indicated by daily step counts	Physical activity will be assessed with a pedometer	Change from baseline to 4 weeks