Mobile Health Application for Adolescents With Asthma

NCT ID: NCT04691557

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-04-29

Brief Summary

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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

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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).

Conditions

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Adolescent Nursing Care Asthma in Children Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A self-efficacy theory based, randomized, 4-week, parallel group study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Mobile Health Application

Intervention Type 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.

Control Group

The control group receives the usual nursing care.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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Mobile Health Application

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 Type OTHER

Usual Care

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Nimet KARATAS

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysegul ISLER DALGIC, Professor

Role: STUDY_DIRECTOR

Akdeniz University

Aysen BINGOL, Professor

Role: STUDY_CHAIR

Akdeniz University

Locations

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Akdeniz University Hospital

Antalya, None Selected, Turkey (Türkiye)

Site Status

Antalya Education and Research Hospital

Antalya, None Selected, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 40928010 (View on PubMed)

Other Identifiers

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2012KAEK20

Identifier Type: -

Identifier Source: org_study_id

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