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Mobile Health Application for Adolescents With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04691557
Recruitment Status : Active, not recruiting
First Posted : December 31, 2020
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Nimet KARATAS, Akdeniz University

Tracking Information
First Submitted Date  ICMJE December 23, 2020
First Posted Date  ICMJE December 31, 2020
Last Update Posted Date May 18, 2022
Actual Study Start Date  ICMJE December 1, 2021
Actual Primary Completion Date April 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2022)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
  • 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).
  • 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).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile Health Application for Adolescents With Asthma
Official Title  ICMJE 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
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.
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 theory-based, assessor-blinded, 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A theory based, outcome assessor blinded, randomized, 4-week, parallel group study
Masking: Single (Outcomes Assessor)
Masking Description:
Single Blinded
Primary Purpose: Supportive Care
Condition  ICMJE
  • Adolescent
  • Nursing Care
  • Asthma in Children
  • Self Efficacy
Intervention  ICMJE
  • Other: 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention Group
    The intervention group receives the YoungAsthma developing for the smartphone or tablet additionally usual nursing care.
    Intervention: Other: Mobile Health Application
  • Active Comparator: Control Group
    The control group receives the usual nursing care.
    Intervention: Other: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 16, 2022)
54
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2020)
100
Estimated Study Completion Date  ICMJE October 2022
Actual Primary Completion Date April 29, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04691557
Other Study ID Numbers  ICMJE 2012KAEK20
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: It has not been yet decided. After the study is finalized, the plan to share individual participant data will be done.
Current Responsible Party Nimet KARATAS, Akdeniz University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Akdeniz University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aysegul ISLER DALGIC, Professor Akdeniz University
Study Chair: Aysen BINGOL, Professor Akdeniz University
PRS Account Akdeniz University
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP