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

NCT03509506 | Completed

• 1 other identifier: 19985
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Self-Management; Mobile Applications; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of Life for Individuals with Heart Failure

  Change from baseline to 4 weeks

• Quality of Life for Individuals with HF

  Change from baseline to 4 weeks

• Physical Activity will be indicated by daily step counts

  Change from baseline to 4 weeks

Study Arms (2)

Non-App Group

NO INTERVENTION

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.

App Group

EXPERIMENTAL

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

Interventions

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.

App Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with chronic heart failure, class I - III based on New York Heart Association (NYHA) scale
• Walking independently with/without an assistive device

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Suh Jen Lin, PhD, PT

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 26, 2018
• Study Start: May 1, 2018
• Primary Completion: July 15, 2020
• Study Completion: February 5, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

US (1)