NCT04691557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

December 23, 2020

Last Update Submit

October 15, 2023

Conditions

AdolescentNursing CareAsthma in ChildrenSelf Efficacy

Keywords

Asthma ControlNursing careMobile HealthSelf-EfficacyRandomized Controlled TrialAdolescent

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group receives the YoungAsthma developing for the smartphone or tablet additionally usual nursing care.

Other: Mobile Health Application

Control Group

ACTIVE COMPARATOR

The control group receives the usual nursing care.

Other: Usual Care

Interventions

Mobile Health ApplicationOTHER

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.

Intervention Group
Usual CareOTHER

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.

Control Group

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Having an internet access problem,
  • Having a psychiatric medical diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akdeniz University Hospital

Antalya, None Selected, 07058, Turkey (Türkiye)

Location

Antalya Education and Research Hospital

Antalya, None Selected, 07058, Turkey (Türkiye)

Location

Related Publications (1)

  • Karatas N, Isler A, Bingol A. Enhancing Adolescent Asthma Control and Self-Efficacy: A Decision Tree Analysis of a Mobile Health Application in a Randomized Controlled Trial. J Eval Clin Pract. 2025 Sep;31(6):e70266. doi: 10.1111/jep.70266.

    PMID: 40928010DERIVED

Study Officials

  • Aysegul ISLER DALGIC, Professor

    Akdeniz University

    STUDY DIRECTOR

  • Aysen BINGOL, Professor

    Akdeniz University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A self-efficacy theory based, randomized, 4-week, parallel group study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 31, 2020

Study Start

December 1, 2021

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

It has not been yet decided. After the study is finalized, the plan to share individual participant data will be done.

Locations

TU(2)