Mobile Health Application for Adolescents With Asthma

October 15, 2023 updated by: Nimet KARATAS, Akdeniz University

Evaluation of the Effectiveness of User-focused Mobile Health Application on Asthma Control and Self-efficacy in Adolescents With Asthma: a Randomized Controlled Trial Protocol

Mobile health applications (mHealth apps) are an opportunity offered by developing technology which in widely used among youths. The evidence regarding mHealth apps suggests that the apps can be safer and more feasible if are developed by healthcare team. Healthcare professionals have a major role to play in developing mHealth apps of good interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims at developing the mHealth application (YoungAsthma) and evaluating the effectiveness of YoungAsthma app on the mean score of the asthma control test and self-efficacy scale in adolescents with asthma. This study is a self-efficacy theory-based, 4-week, randomized parallel group study. Participants will be randomized to either the intervention or control group in a 1:1 ratio. Adolescents will be randomly allocated to intervention (YoungAsthma which is a user-focused mHealth app) or control group (Usual care). The study protocol is conducted in accord with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2013 Statement) (Chan et al., 2013), the RCT is perform by the Consolidated Standards of Reporting Trials (CONSORT) (Moher et al., 2010) and the mHealth app is identified according to the mERA guideline (Agarwal et al., 2016).

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • None Selected
      • Antalya, None Selected, Turkey, 07058
        • Akdeniz University Hospital
      • Antalya, None Selected, Turkey, 07058
        • Antalya Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having ability to speak, read and write Turkish at a sufficient level,
  • Having a diagnosis of asthma for at least a year,
  • Having an asthma control test score of 19 or below,
  • Having ability to use mobile devices,
  • Having a mobile device with an internet connection to login to the mHealth App.

Exclusion Criteria:

  • Having an internet access problem,
  • Having a psychiatric medical diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The intervention group receives the YoungAsthma developing for the smartphone or tablet additionally usual nursing care.
Other: Mobile Health Application
YoungAsthma is a web-based mobile health app has been developing user-focused for adolescents with asthma and evidence-based by the research team. It is the integrated version of the knowledge content to software that enables effective management of asthma by strengthening the interaction between adolescents and healthcare professionals.
Active Comparator: Control Group
The control group receives the usual nursing care.
Other: Usual Care
Adolescents in the control group, an asthma training covering also individualized specific conditions is provided by specialist training nurse for 15-30 minutes in the nursing room of the outpatient clinic for all children. In this nursing intervention that is only one-off and consist face-to-face training with adolescents video and visual materials included in the routine of the outpatient clinic for the use of devices and drugs are used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Efficacy
Time Frame: Assessment of change of the self-efficacy from baseline to 4 weeks will be done.
Self-efficacy will be evaluated by Asthmatic Child and Adolescent Self-Efficacy Scale (ACASES) (Schlösser & Havermans, 1992).
Assessment of change of the self-efficacy from baseline to 4 weeks will be done.
Asthma Control
Time Frame: Assessment of change of the asthma control from baseline to 4 weeks will be done.
Asthma control will be evaluated by the Asthma Control Test (ACT) (Liu et al., 2007).
Assessment of change of the asthma control from baseline to 4 weeks will be done.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Study Director: Aysegul ISLER DALGIC, Professor, Akdeniz University
  • Study Chair: Aysen BINGOL, Professor, Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

April 29, 2022

Study Completion (Actual)

April 29, 2022

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 15, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012KAEK20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It has not been yet decided. After the study is finalized, the plan to share individual participant data will be done.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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