Clinical trial NCT04691557: Mobile Health Application for Adolescents With Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent
Nursing Care
Asthma in Children
Self Efficacy
Keywords: Asthma Control
Nursing care
Mobile Health
Self-Efficacy
Randomized Controlled Trial
Adolescent
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A self-efficacy theory based, randomized, 4-week, parallel group study
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Self-Efficacy
timeFrame: Assessment of change of the self-efficacy from baseline to 4 weeks will be done.
measure: Asthma Control
timeFrame: Assessment of change of the asthma control from baseline to 4 weeks will be done.
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Hospital
state: None Selected
city: Antalya
country: Turkey
facility: Antalya Education and Research Hospital
state: None Selected
Study officials:
affiliation: Akdeniz University
name: Aysegul ISLER DALGIC, Professor
role: STUDY_DIRECTOR
affiliation: Akdeniz University
name: Aysen BINGOL, Professor
role: STUDY_CHAIR
References: