Asthma in ChildrenNCT05633823
The Effect of Mobile Application Game Training Designed for Children
A study testing Mobile Application Game Training in people with Asthma in Children and Life Style, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this research is to examine the effect of mobile application game training designed for children aged 8-16 years on asthma management and quality of life. The population of the study will be children in the 8-12 age group who applied to the Mersin Pediatric Allergy, Asthma and Immunology Specialist's… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Asthma in Children, Life Style, Quality of Life
- What is being tested?
- Mobile Application Game Training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2023to 30 Oct 2023
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between the ages of 8-12
- Having been diagnosed with asthma according to ICD-10 in the last year
- Being on an inhaled corticosteroid or leukotriene antagonist (LTA)
- Not having any other chronic disease
- Having a phone/tablet with a parent or a mobile gameplay feature
- No communication, mental or neurological problems
Show all 9Show fewer
- Volunteering to participate in the study
- Not being obese (3-90% percentile value)
- Moderate or severe asthma according to asthma severity classification
Who cannot join
- Not to be between the ages of 8-12
- Not having been diagnosed with asthma according to ICD-10 in the last year
- Having had a viral infection in the last two weeks
- Not using inhaled corticosteroids
- Having another chronic disease
- Not having a parent or a phone/tablet with mobile gameplay feature
Show all 10Show fewer
- Having a communication, mental or neurological problem
- Not volunteering to participate in the study
- Being obese (more than 90% percentile)
- Mild asthma according to asthma severity classification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobile Application Game Training Designed for Children With Asthma on Asthma Management
The aim of this research is to examine the effect of mobile application game training designed for children aged 8-16 years on asthma management and quality of life. The population of the study will be children in the 8-12 age group who applied to the Mersin Pediatric Allergy, Asthma and Immunology Specialist's clinic, and the sample will consist of 78 children with asthma who meet the criteria for inclusion in the research. This age group has problems in solving abstract problems, it is necessary to embody it in order to facilitate the understanding of the disease process. Therefore, it is important to embody the training given in the increase of self-management related to the disease process of this age group. While determining the sample size of the study, Arıkan-Ayyıldız et al. (2016) based on the scientific study named "Efficacy of asthma education program on asthma control in children with uncontrolled asthma". In the Arıkan-Ayyıldız study, it was reported that the total mean score of "ACT" (Asthma Control Test-Asthma Control Test) was 13.8±3.4 in the experimental group and 15.6±3.2 in the control group. As a result of the Power analysis (G*Power 3.1.9.2) made according to these data; effect size = 0.78, with 95% confidence interval, 95% power, it was calculated that a total of 72 children with asthma, at least 36 in each group, should be included. Considering that there may be dropout and confounders during the research process, the number of groups was increased by 10%. The sample of the research; was a total of 78 children, including 39 children in each intervention group.
In collecting research data; the Child and Parent Information Form, Inhaler Usage Skills Evaluation Form, Asthma Symptom and Treatment Need Scoring, DISABKIDS Asthma Scale will be used. A statistical package program (SPSS 20) will be used in the analysis of the research data. The statistical significance level was determined as 0.05. Kolmogorov-Smirnov will be used in the normality analysis of dependent variables. Chi-square and mean-to-means comparison tests will be used to determine the similarity of the groups. Appropriate parametric or non-parametric tests will be used according to the distribution's normality in comparing the means between groups and within groups.
Read the detailed description
- Data will be collected in the waiting room after the child is examined at the clinic. In data collection, the pediatric patients who applied to the clinic of the Pediatric Allergy, Asthma and Immunology Specialist who met the inclusion criteria of the study and agreed to participate in the study, and their parents, who were diagnosed with asthma at least one year ago, will be informed about the purpose of the study and their parents, and their verbal and written consent will be obtained.
- Randomization will be provided by randomly and evenly dividing the patients who meet the sample selection criteria into 2 groups (1st experimental group, 2nd group control group) through a computer program (http://www1.assumption.edu/users/avadum/applets/). RandAssign/GroupGen.html).
- The data collection forms in the research will be applied to the children and parents in the sample group.
- Mobile application game training will be introduced to the children and parents in the experimental group and they will be provided to download the application to their mobile device or tablet.
- Data collection forms will be re-applied immediately after children complete one round of the game, 4 months and 6 months after the training.
- No application will be made to the children and parents in the control group, and the forms will be re-applied 4 months and 6 months after the first application of the data collection forms.
- Conditions
- Asthma in Children, Life Style, Quality of Life
- Being tested
- Mobile Application Game Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application Game TrainingOther
Mobile application game training can be used interactively with smartphones and tablets.
- A user account will be created after the application is downloaded to the mobile phone/tablet.
- After logging into the application, the map of the game will be displayed.
- The game will start with the first level of the game consisting of 5 levels.
- At each level, first of all, educational videos prepared in the form of short (1-2 minutes) animations will be watched. The number of videos varies between 1 and 3.
- After watching the videos, interactive games will be played.
- Children are required to complete each stage in the game, and each stage is planned to take approximately 7-10 minutes.
- After passing the first level, children will be able to move on to the next level of games and will not be able to move on to the next level until the previous level is finished.
| Study group | Role | What they receive |
|---|---|---|
| Game group | Experimental | Children and parents will be introduced to mobile application game training and they will be provided to download the application to their mobile device or tablet. The data collection forms will be applied again immediately after the children complete each part of the game, 4 months and 6 months after the training. Receives: Other: Mobile Application Game Training |
| Control group | No intervention | No application will be made to children and parents, and the forms will be re-applied 4 months and 6 months after the first application of the data collection forms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using Inhaler Skill Evaluation Form
The Skills Evaluation Form was prepared by using the brochure and literature prepared by the Turkish Respiratory Research Association Inhalation Therapies Working Group, based on correct inhalation techniques. The form consists of 10 skill steps in which the skills of using inhalation devices used in the treatment of asthma are evaluated. There are 4 subgroups in the form, including metered dose inhaler (MDI), turbohaler, discus and aerolizer type instruments. According to the scoring system used in the researches, "0" points are given for "Wrong" or skipped steps, and "1" points are given for "Correct" steps. A score between 0 and 10 is obtained by summing the scores obtained from all the steps evaluated by the direct observation method. The form will be filled by the same researcher using the observation method. In cases where more than one inhaler device is used, the average score will be taken. In the evaluation of the form; A high score indicates a good level of inhaler use.
Measured: 1 day
Asthma Symptom and Need for Treatment Scoring
This form was created to monitor the changes in the clinical symptoms of children with asthma (Liu et al., 2007; Al Aloola et al., 2017). It will be given at the beginning of the study so that the child and their parents can record their asthma symptoms. in form; respiratory tract complaints and asthma symptoms (cough, wheezing, shortness of breath, frequent breathing, phlegm, night cough), nasal complaints/ rhinitis symptoms (runny nose, congestion, sneezing, itchy eyes, watery eyes and itchy nose) no symptoms according to the degree of complaint It is scored as 0 if it is light, 2 if it is moderate, and 3 if it is heavy. These symptom scores will be calculated as asthma symptom score (ASS) and rhinitis symptom score (RSS) by giving the mean value. Total symptom score (TSS) will be taken as the sum of ASS and RSS.
Measured: 1 day
DISABKIDS Asthma Scale
The questions in the scale are evaluated using 1-5 point Likert type questions. "1" represents the most negative rating and "5" represents the most positive rating. The score weights of the questions are equal. The total score for all items is between 11-55. The scale has two sub-dimensions as effect and anxiety. There are 6 questions in the effect dimension and 5 questions in the anxiety dimension. In addition, there is an additional symptom section consisting of three questions for symptom control. This section is not included in the scoring, it provides an idea about the patient's asthma status. It is thought that the higher the score the patient gets from the scale, the better the quality of life. The cronbach alpha value of the scale is 0.86
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start10 Apr 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiye Karakul, Tarsus University
- Investigators
- Duygu Sönmez Düzkaya, Principal investigator, Tarsus UniversityGamze Bozkul, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633823
- Sponsor's protocol ID
- 2022/13
- Status last verified
- Apr 2023
- First submitted
- 18 Nov 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Aloola NA, Nissen L, Alewairdhi HA, Al Faryan N, Saini B. Parents' asthma information needs and preferences for school-based asthma support. J Asthma. 2017 Nov;54(9):946-956. doi: 10.1080/02770903.2017.1281296. Epub 2017 Jan 17.
PubMed 28095117Arikan-Ayyildiz Z, Isik S, Caglayan-Sozmen S, Anal O, Karaman O, Uzuner N. Efficacy of asthma education program on asthma control in children with uncontrolled asthma. Turk J Pediatr. 2016;58(4):383-388. doi: 10.24953/turkjped.2016.04.006.
PubMed 28276210Bruggers CS, Baranowski S, Beseris M, Leonard R, Long D, Schulte E, Shorter A, Stigner R, Mason CC, Bedrov A, Pascual I, Bulaj G. A Prototype Exercise-Empowerment Mobile Video Game for Children With Cancer, and Its Usability Assessment: Developing Digital Empowerment Interventions for Pediatric Diseases. Front Pediatr. 2018 Apr 9;6:69. doi: 10.3389/fped.2018.00069. eCollection 2018.
PubMed 29686977Castro-Rodriguez JA, Forno E, Rodriguez-Martinez CE, Celedon JC. Risk and Protective Factors for Childhood Asthma: What Is the Evidence? J Allergy Clin Immunol Pract. 2016 Nov-Dec;4(6):1111-1122. doi: 10.1016/j.jaip.2016.05.003. Epub 2016 Jun 8.
PubMed 27286779Cheng J, Wang H, Zhang X, Guo H, Duan H. The factors of family management affecting asthma control status in school-age children with asthma in China. J Asthma. 2022 May;59(5):1041-1050. doi: 10.1080/02770903.2021.1895209. Epub 2021 Mar 22.
PubMed 33629923Cook KA, Modena BD, Simon RA. Improvement in Asthma Control Using a Minimally Burdensome and Proactive Smartphone Application. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):730-737.e1. doi: 10.1016/j.jaip.2016.03.005. Epub 2016 Apr 20.
PubMed 27107690Davis SR, Peters D, Calvo RA, Sawyer SM, Foster JM, Smith LD. A consumer designed smartphone app for young people with asthma: pilot of engagement and acceptability. J Asthma. 2021 Feb;58(2):253-261. doi: 10.1080/02770903.2019.1680997. Epub 2019 Nov 6.
PubMed 31691618Deniz PÖ, Abacıgil F, Uysal P. Çocuk ve Ergenlerde Disabkids Astım Modülünün Geçerlilik ve Güvenilirliği. 4. Uluslararası 22. Ulusal Halk Sağlığı Kongresi, 2020.
Fedele DA, McConville A, Graham Thomas J, McQuaid EL, Janicke DM, Turner EM, Moon J, Abu-Hasan M. Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT): Development and design of a randomized controlled trial. Contemp Clin Trials. 2018 Jan;64:230-237. doi: 10.1016/j.cct.2017.09.007. Epub 2017 Oct 3.
PubMed 28986245Fedele DA, Thomas JG, McConville A, McQuaid EL, Voorhees S, Janicke DM, Abu-Hasan M, Chi X, Gurka MJ. Using Mobile Health to Improve Asthma Self-Management in Early Adolescence: A Pilot Randomized Controlled Trial. J Adolesc Health. 2021 Dec;69(6):1032-1040. doi: 10.1016/j.jadohealth.2021.06.011. Epub 2021 Jul 15.
PubMed 34274211Franzmair J, Diesner-Treiber SC, Voitl JJM, Voitl P. Effective German and English Language mHealth Apps for Self-management of Bronchial Asthma in Children and Adolescents: Comparison Study. JMIR Mhealth Uhealth. 2021 May 19;9(5):e24907. doi: 10.2196/24907.
PubMed 34009134Fuemmeler BF, Holzwarth E, Sheng Y, Do EK, Miller CA, Blatt J, Rosoff PM, Ostbye T. Mila Blooms: A Mobile Phone Application and Behavioral Intervention for Promoting Physical Activity and a Healthy Diet Among Adolescent Survivors of Childhood Cancer. Games Health J. 2020 Aug;9(4):279-289. doi: 10.1089/g4h.2019.0060. Epub 2020 May 8.
PubMed 32391734Gibson PG, Powell H, Coughlan J, Wilson AJ, Abramson M, Haywood P, Bauman A, Hensley MJ, Walters EH. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev. 2003;(1):CD001117. doi: 10.1002/14651858.CD001117.
PubMed 12535399Haktanir Abul M, Phipatanakul W. Severe asthma in children: Evaluation and management. Allergol Int. 2019 Apr;68(2):150-157. doi: 10.1016/j.alit.2018.11.007. Epub 2019 Jan 14.
PubMed 30648539Hsia B, Mowrey W, Keskin T, Wu S, Aita R, Kwak L, Ferastraoarou D, Rosenstreich D, Jariwala SP. Developing and pilot testing ASTHMAXcel, a mobile app for adults with asthma. J Asthma. 2021 Jun;58(6):834-847. doi: 10.1080/02770903.2020.1728770. Epub 2020 Feb 19.
PubMed 32046564
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Application Game Training Designed for Children With Asthma on Asthma Management
- ClinicalTrials.gov ID
- NCT05633823
- Acronym / sponsor ID
- 2022/13
- Conditions
- Asthma in Children, Life Style, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 1 Dec 2022 (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.
The aim of this research is to examine the effect of mobile application game training designed for children aged 8-16 years on asthma management and quality of life. The population of the study will be children in the 8-12 age group who applied to the Mersin Pediatric Allergy, Asthma and Immunology Specialist's clinic, and the sample will consist of 78 children with asthma who meet the criteria for inclusion in the research. This age group has problems in solving abstract problems, it is necessary to embody it in order to facilitate the understanding of the disease process. Therefore, it is important to embody the training given in the increase of self-management related to the disease process of this age group. While determining the sample size of the study, Arıkan-Ayyıldız et al. (2016) based on the scientific study named "Efficacy of asthma education program on asthma control in children with uncontrolled asthma". In the Arıkan-Ayyıldız study, it was reported that the total mean score of "ACT" (Asthma Control Test-Asthma Control Test) was 13.8±3.4 in the experimental group and 15.6±3.2 in the control group. As a result of the Power analysis (G*Power 3.1.9.2) made according to these data; effect size = 0.78, with 95% confidence interval, 95% power, it was calculated that a total of 72 children with asthma, at least 36 in each group, should be included. Considering that there may be dropout and confounders during the research process, the number of groups was increased by 10%. The sample of the research; was a total of 78 children, including 39 children in each intervention group.
In collecting research data; the Child and Parent Information Form, Inhaler Usage Skills Evaluation Form, Asthma Symptom and Treatment Need Scoring, DISABKIDS Asthma Scale will be used. A statistical package program (SPSS 20) will be used in the analysis of the research data. The statistical significance level was determined as 0.05. Kolmogorov-Smirnov will be used in the normality analysis of dependent variables. Chi-square and mean-to-means comparison tests will be used to determine the similarity of the groups. Appropriate parametric or non-parametric tests will be used according to the distribution's normality in comparing the means between groups and within groups.
Detailed description
- Data will be collected in the waiting room after the child is examined at the clinic. In data collection, the pediatric patients who applied to the clinic of the Pediatric Allergy, Asthma and Immunology Specialist who met the inclusion criteria of the study and agreed to participate in the study, and their parents, who were diagnosed with asthma at least one year ago, will be informed about the purpose of the study and their parents, and their verbal and written consent will be obtained.
- Randomization will be provided by randomly and evenly dividing the patients who meet the sample selection criteria into 2 groups (1st experimental group, 2nd group control group) through a computer program (http://www1.assumption.edu/users/avadum/applets/). RandAssign/GroupGen.html).
- The data collection forms in the research will be applied to the children and parents in the sample group.
- Mobile application game training will be introduced to the children and parents in the experimental group and they will be provided to download the application to their mobile device or tablet.
- Data collection forms will be re-applied immediately after children complete one round of the game, 4 months and 6 months after the training.
- No application will be made to the children and parents in the control group, and the forms will be re-applied 4 months and 6 months after the first application of the data collection forms.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game group | Experimental | Other: Mobile Application Game TrainingChildren and parents will be introduced to mobile application game training and they will be provided to download the application to their mobile device or tablet. The data collection forms will be applied again immediately after the children complete each part of the game, 4 months and 6 months after the training. |
| Control group | No intervention | –No application will be made to children and parents, and the forms will be re-applied 4 months and 6 months after the first application of the data collection forms. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Being between the ages of 8-12
- Having been diagnosed with asthma according to ICD-10 in the last year
- Being on an inhaled corticosteroid or leukotriene antagonist (LTA)
- Not having any other chronic disease
- Having a phone/tablet with a parent or a mobile gameplay feature
Key exclusion criteria (10 listed)
- Not to be between the ages of 8-12
- Not having been diagnosed with asthma according to ICD-10 in the last year
- Having had a viral infection in the last two weeks
- Not using inhaled corticosteroids
- Having another chronic disease
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 Application Game TrainingMobile application game training can be used interactively with smartphones and tablets. * A user account will be created after the application is downloaded to the mobile phone/tablet. * After logging into the application, the map of the game will be displayed. * The game will start with the first level of the game consisting of 5 levels. * At each level, first of all, educational videos prepared in the form of short (1-2 minutes) animations will be watched. The number of videos varies between 1 and 3. * After watching the videos, interactive games will be played. * Children are required to complete each stage in the game, and each stage is planned to take approximately 7-10 minutes. * After passing the first level, children will be able to move on to the next level of games and will not be able to move on to the next level until the previous level is finished. | Other | Game group |
Primary outcome
Using Inhaler Skill Evaluation Form
Time frame: 1 day
The Skills Evaluation Form was prepared by using the brochure and literature prepared by the Turkish Respiratory Research Association Inhalation Therapies Working Group, based on correct inhalation techniques. The form consists of 10 skill steps in which the skills of using inhalation devices used in the treatment of asthma are evaluated. There are 4 subgroups in the form, including metered dose inhaler (MDI), turbohaler, discus and aerolizer type instruments. According to the scoring system used in the researches, "0" points are given for "Wrong" or skipped steps, and "1" points are given for "Correct" steps. A score between 0 and 10 is obtained by summing the scores obtained from all the steps evaluated by the direct observation method. The form will be filled by the same researcher using the observation method. In cases where more than one inhaler device is used, the average score will be taken. In the evaluation of the form; A high score indicates a good level of inhaler use.
Asthma Symptom and Need for Treatment Scoring
Time frame: 1 day
This form was created to monitor the changes in the clinical symptoms of children with asthma (Liu et al., 2007; Al Aloola et al., 2017). It will be given at the beginning of the study so that the child and their parents can record their asthma symptoms. in form; respiratory tract complaints and asthma symptoms (cough, wheezing, shortness of breath, frequent breathing, phlegm, night cough), nasal complaints/ rhinitis symptoms (runny nose, congestion, sneezing, itchy eyes, watery eyes and itchy nose) no symptoms according to the degree of complaint It is scored as 0 if it is light, 2 if it is moderate, and 3 if it is heavy. These symptom scores will be calculated as asthma symptom score (ASS) and rhinitis symptom score (RSS) by giving the mean value. Total symptom score (TSS) will be taken as the sum of ASS and RSS.
DISABKIDS Asthma Scale
Time frame: 1 day
The questions in the scale are evaluated using 1-5 point Likert type questions. "1" represents the most negative rating and "5" represents the most positive rating. The score weights of the questions are equal. The total score for all items is between 11-55. The scale has two sub-dimensions as effect and anxiety. There are 6 questions in the effect dimension and 5 questions in the anxiety dimension. In addition, there is an additional symptom section consisting of three questions for symptom control. This section is not included in the scoring, it provides an idea about the patient's asthma status. It is thought that the higher the score the patient gets from the scale, the better the quality of life. The cronbach alpha value of the scale is 0.86
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 27 Nov 2023.
- Background: PubMed 28095117Al Aloola NA, Nissen L, Alewairdhi HA, Al Faryan N, Saini B. Parents' asthma information needs and preferences for school-based asthma support. J Asthma. 2017 Nov;54(9):946-956. doi: 10.1080/02770903.2017.1281296. Epub 2017 Jan 17.
- Background: PubMed 28276210Arikan-Ayyildiz Z, Isik S, Caglayan-Sozmen S, Anal O, Karaman O, Uzuner N. Efficacy of asthma education program on asthma control in children with uncontrolled asthma. Turk J Pediatr. 2016;58(4):383-388. doi: 10.24953/turkjped.2016.04.006.
- Background: PubMed 29686977Bruggers CS, Baranowski S, Beseris M, Leonard R, Long D, Schulte E, Shorter A, Stigner R, Mason CC, Bedrov A, Pascual I, Bulaj G. A Prototype Exercise-Empowerment Mobile Video Game for Children With Cancer, and Its Usability Assessment: Developing Digital Empowerment Interventions for Pediatric Diseases. Front Pediatr. 2018 Apr 9;6:69. doi: 10.3389/fped.2018.00069. eCollection 2018.
- Background: PubMed 27286779Castro-Rodriguez JA, Forno E, Rodriguez-Martinez CE, Celedon JC. Risk and Protective Factors for Childhood Asthma: What Is the Evidence? J Allergy Clin Immunol Pract. 2016 Nov-Dec;4(6):1111-1122. doi: 10.1016/j.jaip.2016.05.003. Epub 2016 Jun 8.
- Background: PubMed 33629923Cheng J, Wang H, Zhang X, Guo H, Duan H. The factors of family management affecting asthma control status in school-age children with asthma in China. J Asthma. 2022 May;59(5):1041-1050. doi: 10.1080/02770903.2021.1895209. Epub 2021 Mar 22.
- Background: PubMed 27107690Cook KA, Modena BD, Simon RA. Improvement in Asthma Control Using a Minimally Burdensome and Proactive Smartphone Application. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):730-737.e1. doi: 10.1016/j.jaip.2016.03.005. Epub 2016 Apr 20.
- Background: PubMed 31691618Davis SR, Peters D, Calvo RA, Sawyer SM, Foster JM, Smith LD. A consumer designed smartphone app for young people with asthma: pilot of engagement and acceptability. J Asthma. 2021 Feb;58(2):253-261. doi: 10.1080/02770903.2019.1680997. Epub 2019 Nov 6.
- BackgroundDeniz PÖ, Abacıgil F, Uysal P. Çocuk ve Ergenlerde Disabkids Astım Modülünün Geçerlilik ve Güvenilirliği. 4. Uluslararası 22. Ulusal Halk Sağlığı Kongresi, 2020.
- Background: PubMed 28986245Fedele DA, McConville A, Graham Thomas J, McQuaid EL, Janicke DM, Turner EM, Moon J, Abu-Hasan M. Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT): Development and design of a randomized controlled trial. Contemp Clin Trials. 2018 Jan;64:230-237. doi: 10.1016/j.cct.2017.09.007. Epub 2017 Oct 3.
- Background: PubMed 34274211Fedele DA, Thomas JG, McConville A, McQuaid EL, Voorhees S, Janicke DM, Abu-Hasan M, Chi X, Gurka MJ. Using Mobile Health to Improve Asthma Self-Management in Early Adolescence: A Pilot Randomized Controlled Trial. J Adolesc Health. 2021 Dec;69(6):1032-1040. doi: 10.1016/j.jadohealth.2021.06.011. Epub 2021 Jul 15.
- Background: PubMed 34009134Franzmair J, Diesner-Treiber SC, Voitl JJM, Voitl P. Effective German and English Language mHealth Apps for Self-management of Bronchial Asthma in Children and Adolescents: Comparison Study. JMIR Mhealth Uhealth. 2021 May 19;9(5):e24907. doi: 10.2196/24907.
- Background: PubMed 32391734Fuemmeler BF, Holzwarth E, Sheng Y, Do EK, Miller CA, Blatt J, Rosoff PM, Ostbye T. Mila Blooms: A Mobile Phone Application and Behavioral Intervention for Promoting Physical Activity and a Healthy Diet Among Adolescent Survivors of Childhood Cancer. Games Health J. 2020 Aug;9(4):279-289. doi: 10.1089/g4h.2019.0060. Epub 2020 May 8.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Asthma in Children
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.
Duygu Sönmez Düzkaya principal investigator
Tarsus University
Gamze Bozkul principal investigator
Tarsus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application Game Training in people with Asthma in Children and Life Style, run by Tarsus University at 1 site 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 9 inclusion and 10 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Using Inhaler Skill Evaluation Form (time frame: 1 day). The study lists 3 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 NCT05633823, which also lists 32 linked publications.
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 27 Nov 2023; AzTrials last refreshed its copy on 2 Nov 2026.