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

NCT ID: NCT03509506

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-02-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Self-Management Mobile Applications Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

App Group

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Woman's University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suh Jen Lin, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Locations

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Texas Woman's University

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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19985

Identifier Type: -

Identifier Source: org_study_id

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