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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03509506
Enrollment
18
Registered
2018-04-26
Start date
2018-05-01
Completion date
2021-02-05
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self-Management, Mobile Applications, Heart Failure

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.

Interventions

BEHAVIORALApp 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.

Sponsors

Texas Woman's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of ExperienceChange from baseline to 4 weeksThe Quality of Experience (QoE) survey will be used to measure the quality of experience in using the mobile application

Secondary

MeasureTime frameDescription
Quality of Life for Individuals with Heart FailureChange from baseline to 4 weeks36-Item Short-Form Health Survey (SF-36 version 1.0)
Quality of Life for Individuals with HFChange from baseline to 4 weeksMinnesota Living with Heart Failure (MLHF) questionnaire
Physical Activity will be indicated by daily step countsChange from baseline to 4 weeksPhysical activity will be assessed with a pedometer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026