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Clinical Trials/NCT04691557
NCT04691557
Completed
Not Applicable

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

Akdeniz University2 sites in 1 country54 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent
Sponsor
Akdeniz University
Enrollment
54
Locations
2
Primary Endpoint
Asthma Control
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

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).

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
April 29, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nimet KARATAS

Research Assistant

Akdeniz University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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).

Study Sites (2)

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