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Completed

NCT Number: NCT04691557

Mobile Health Application for Adolescents With Asthma

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.

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Key information

Conditions

Adolescent Asthma in Children Nursing Care Self Efficacy

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University Hospital, Antalya, None Selected, Turkey (Türkiye)

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile health application

Other

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

Other

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.

Primary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 31, 2020
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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