AdolescentNCT04691557
Mobile Health Application for Adolescents With Asthma
A study testing Mobile Health Application in people with Adolescent and Nursing Care, run by Akdeniz University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescent, Nursing Care, Asthma in Children
- What is being tested?
- Mobile Health Application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Having an internet access problem,
- Having a psychiatric medical diagnosis
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Akdeniz University Hospital
Antalya, None Selected, 07058
Antalya Education and Research Hospital
Antalya, None Selected, 07058
About this study
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
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.
Read the 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).
- Conditions
- Adolescent, Nursing Care, Asthma in Children, Self Efficacy
- Being tested
- Mobile Health Application, Usual Care
- Keywords
- Asthma Control, Nursing care, Mobile Health, Self-Efficacy, Randomized Controlled Trial, Adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group receives the YoungAsthma developing for the smartphone or tablet additionally usual nursing care. Receives: Other: Mobile Health Application |
| Control Group | Active comparator | The control group receives the usual nursing care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy
Self-efficacy will be evaluated by Asthmatic Child and Adolescent Self-Efficacy Scale (ACASES) (Schlösser \& Havermans, 1992).
Measured: 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).
Measured: Assessment of change of the asthma control from baseline to 4 weeks will be done.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Dec 2021
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdolescentStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A self-efficacy theory based, randomized, 4-week, parallel group study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimet KARATAS, Akdeniz University
- Investigators
- Aysegul ISLER DALGIC, Professor, Study director, Akdeniz UniversityAysen BINGOL, Professor, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691557
- Sponsor's protocol ID
- 2012KAEK20
- Status last verified
- Oct 2023
- First submitted
- 23 Dec 2020
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It has not been yet decided. After the study is finalized, the plan to share individual participant data will be done.
Publications
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.
PubMed 40928010
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04691557
- Acronym / sponsor ID
- 2012KAEK20
- Conditions
- Adolescent, Nursing Care, Asthma in Children, Self Efficacy
- Keywords
- Asthma Control, Nursing care, Mobile Health, Self-Efficacy, Randomized Controlled Trial, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A self-efficacy theory based, randomized, 4-week, parallel group study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Mobile Health ApplicationThe intervention group receives the YoungAsthma developing for the smartphone or tablet additionally usual nursing care. |
| Control Group | Active comparator | Other: Usual CareThe control group receives the usual nursing care. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Having an internet access problem,
- Having a psychiatric medical diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health ApplicationYoungAsthma 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. | Other | Intervention Group |
| Usual CareAdolescents 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. | Other | Control Group |
Primary outcome
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Derived from this study: PubMed 40928010Karatas 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.
- Individual participant dataSharing planned: No. It has not been yet decided. After the study is finalized, the plan to share individual participant data will be done.
Related trials for Adolescent
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Structural Stressors, Reward Related Decision Making and Substance Use Risk
Substance Use Risk, Structural Stressors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysegul ISLER DALGIC, Professor study director
Akdeniz University
Aysen BINGOL, Professor study chair
Akdeniz University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Application in people with Adolescent and Nursing Care, run by Akdeniz University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy (time frame: Assessment of change of the self-efficacy from baseline to 4 weeks will be done.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.