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History of Changes for Study: NCT04691557
Mobile Health Application for Adolescents With Asthma
Latest version (submitted May 16, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 29, 2020 None (earliest Version on record)
2 December 1, 2021 Study Status, Study Design, Eligibility, Arms and Interventions, Conditions, Study Description, IPDSharing, Outcome Measures and Study Identification
3 March 7, 2022 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Study Design and Study Description
4 May 16, 2022 Recruitment Status, Study Status, Contacts/Locations, Study Design and Eligibility
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Study NCT04691557
Submitted Date:  December 29, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2012KAEK20
Brief Title: Mobile Health Application for Adolescents With Asthma
Official Title: The Efficiency of Mobile Health Application for Asthma Control and Self-Efficacy in Adolescents With Asthma: A Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2020
Overall Status: Not yet recruiting
Study Start: March 2021
Primary Completion: December 2021 [Anticipated]
Study Completion: January 2022 [Anticipated]
First Submitted: December 23, 2020
First Submitted that
Met QC Criteria:
December 29, 2020
First Posted: December 31, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
December 29, 2020
Last Update Posted: December 31, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Akdeniz University
Responsible Party: Principal Investigator
Investigator: Nimet KARATAS
Official Title: Research Assistant
Affiliation: Akdeniz University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Mobile health applications (mHealth app) 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 (AST-M) and evaluating the effectiveness of AST-M app on the mean score of the asthma control test, self-efficacy scale and quality of life questionaire in adolescents with asthma. This study is a theory-based, single centre, assessor-blinded, 12-week, randomized parallel group study. After baseline assessment participants will be randomized to either the intervention or control group in a 1:1 ratio. Adolescents will be stratified based on age of years and randomly allocated to intervention (AST-M which is a user-focused mHealth app) or control group (Usual care) through block randomization. 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 intervention is described according to the mERA guideline (Agarwal et al., 2016). This study will be carried out in pediatric allergy and immunology outpatient clinic of the university hospital which has the largest patient population of asthma, located in the centre of the city. Adolescent with asthma are routinely invited to the outpatient clinic once every three months.
Open or close this module Conditions
Conditions: Self Efficacy
Asthma in Children
Nurse's Role
Quality of Life
Mobile Phone Use
Keywords: Asthma Control
Nursing Informatics
Mobile Health
Self-Efficacy
Randomized Controlled Trial
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
A theory based, single center, outcome assessor blinded, randomized, 12-week, parallel group study
Number of Arms: 2
Masking: Double (Care Provider, Outcomes Assessor)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Intervention Group
The intervention group receives the mobile health application delivered for the smartphone additionally to usual care. The application named "AST-M" is a web-based mobile health app has been developing user-focused for adolescents with asthma by the research team.
Mobile Health Application
AST-M is designed as an adolescent-focused, interesting, creative, useful, provide unlimited and unimpeded access to information resources, mobile interfaces that can be individualized and enable self-learning, connect in-depth information enriched with much visual content and a communication channel with healthcare professional that they can consult whenever they wish. Also content of the app is based on Social Cognitive Theory (Bandura, 1986)
Active Comparator: Control Group
Adolescents in the control group, an asthma training covering also individualized specific conditions is provided by education nurses for 15-30 minutes in the nursing room of the outpatient clinic for all children. In this training with adolescents, video and visual materials included in the routine of the outpatient clinic for the use of devices and drugs are used.
Usual Care
Adolescents in the control group, an asthma training covering also individualized specific conditions is provided by education nurses for 15-30 minutes in the nursing room of the outpatient clinic for all children. In this training with adolescents, video and visual materials included in the routine of the outpatient clinic for the use of devices and drugs are used.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Self-Efficacy
[ Time Frame: Assessment of change of the self-efficacy from baseline to 12 weeks will be done. ]

Self-efficacy will be measured by Asthmatic Child and Adolescent Self-Efficacy Scale (ACASES). The ACASES, which can be filled by the adolescents themselves, consists of 22 items and 3 sub-dimensions was developed for adolescents between the ages of 10-18 years. A minimum of 22 and a maximum of 110 points can be obtained on the scale. The high scores of the scale indicate that the adolescent has high self-efficacy (Schlösser & Havermans, 1992).
2. Asthma Control
[ Time Frame: Assessment of change of the asthma control from baseline to 12 weeks will be done. ]

Asthma control will be measured by the Asthma Control Test (ACT). ACT is a 5-item questionnaire that provides information about the level of control of asthma. The lowest possible score is 5, the highest score is 25. In the evaluation, 25 points are evaluated as: "full control", 24-20 points: "partial control", 19 points and below: "not under control" (Liu et al., 2007).
Secondary Outcome Measures:
1. Asthma Quality of Life
[ Time Frame: Assessment of change of the quality of life from baseline to 12 weeks will be done. ]

The quality of life will be measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). The PAQLQ is 7-point Likert type, consists of 23 items and 3 dimensions, developed for the 7-17 age range (Juniper, 1997).
Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age: 18 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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 24 or below,
  • Having ability to use mobile devices,
  • Having a mobile phone with an internet connection to download the mHealth app.

Exclusion Criteria:

  • Having an internet access problem,
  • Having a psychiatric medical diagnosis,
  • Having a chronic disease accompanying asthma such as cystic fibrozis.
Open or close this module Contacts/Locations
Central Contact Person: Nimet Karatas, Res. Asst.
Telephone: +905556963374
Email: nimetkaratas@akdeniz.edu.tr
Study Officials: Aysegul ISLER DALGIC, Professor
Study Director
Akdeniz University
Aysen BINGOL, Professor
Study Chair
Akdeniz University
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
It has not been yet decided. After the study is finalized, the plan to make individual participant data will be done.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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