Viewing Study NCT04691557


Ignite Creation Date: 2025-12-24 @ 7:02 PM
Ignite Modification Date: 2025-12-25 @ 4:36 PM
Study NCT ID: NCT04691557
Status: COMPLETED
Last Update Posted: 2023-10-17
First Post: 2020-12-23
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Mobile Health Application for Adolescents With Asthma
Sponsor: Akdeniz University
Organization:

Study Overview

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
Status: COMPLETED
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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).

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: