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OpenTrials
Completed

NCT Number: NCT03509506

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.

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Key information

Conditions

Self-management Cardiovascular Diseases Heart Diseases Heart Failure Mobile Applications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

App Group

Behavioral

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.

Primary outcomes

  1. Quality of Experience

    Time frame: 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 outcomes

  1. Quality of Life for Individuals with Heart Failure

    Time frame: Change from baseline to 4 weeks

    36-Item Short-Form Health Survey (SF-36 version 1.0)

  2. Quality of Life for Individuals with HF

    Time frame: Change from baseline to 4 weeks

    Minnesota Living with Heart Failure (MLHF) questionnaire

  3. Physical Activity will be indicated by daily step counts

    Time frame: Change from baseline to 4 weeks

    Physical activity will be assessed with a pedometer

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 26, 2018
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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