Mobile Health Application for Adolescents With Asthma

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691557
• Other study ID #: 2012KAEK20
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: April 29, 2022

Study information

• Verified date: October 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent
• Asthma
• Asthma in Children
• Nursing Care
• Self Efficacy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Akdeniz University Hospital	Antalya	None Selected
Turkey	Antalya Education and Research Hospital	Antalya	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Efficacy	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.
Primary	Asthma Control	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.