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

Primary Purpose

Self-Management, Mobile Applications, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
App Group
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Self-Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Texas Woman's University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non-App Group

App Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of Experience
The Quality of Experience (QoE) survey will be used to measure the quality of experience in using the mobile application

Secondary Outcome Measures

Quality of Life for Individuals with Heart Failure
36-Item Short-Form Health Survey (SF-36 version 1.0)
Quality of Life for Individuals with HF
Minnesota Living with Heart Failure (MLHF) questionnaire
Physical Activity will be indicated by daily step counts
Physical activity will be assessed with a pedometer

Full Information

First Posted
April 9, 2018
Last Updated
April 22, 2022
Sponsor
Texas Woman's University
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1. Study Identification

Unique Protocol Identification Number
NCT03509506
Brief Title
A Self-care Mobile Health App in Individuals With Heart Failure
Official Title
Usability and Effectiveness of a Self-care Mobile Health App in Individuals With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
February 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Woman's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Management, Mobile Applications, Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-App Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
App Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
App Group
Intervention Description
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 Outcome Measure Information:
Title
Quality of Experience
Description
The Quality of Experience (QoE) survey will be used to measure the quality of experience in using the mobile application
Time Frame
Change from baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Quality of Life for Individuals with Heart Failure
Description
36-Item Short-Form Health Survey (SF-36 version 1.0)
Time Frame
Change from baseline to 4 weeks
Title
Quality of Life for Individuals with HF
Description
Minnesota Living with Heart Failure (MLHF) questionnaire
Time Frame
Change from baseline to 4 weeks
Title
Physical Activity will be indicated by daily step counts
Description
Physical activity will be assessed with a pedometer
Time Frame
Change from baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suh Jen Lin, PhD, PT
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Woman's University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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

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