Mobile Health Application for Adolescents With Asthma

• ClinicalTrials.gov Identifier: NCT04691557
• Recruitment Status: Active, not recruiting
• First Posted: December 31, 2020
• Last Update Posted: May 18, 2022
• Sponsor: Akdeniz University
• Information provided by (Responsible Party): Nimet KARATAS, Akdeniz University

Tracking Information

• First Submitted Date: December 23, 2020
• First Posted Date: December 31, 2020
• Last Update Posted Date: May 18, 2022
• Actual Study Start Date: December 1, 2021
• Actual Primary Completion Date: April 29, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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).

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: Mobile Health Application for Adolescents With Asthma
• 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
• 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Adolescent
• Nursing Care
• Asthma in Children
• Self Efficacy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 16, 2022): 54
• Original Estimated Enrollment (submitted: December 29, 2020): 100
• Estimated Study Completion Date: October 2022
• Actual Primary Completion Date: April 29, 2022 (Final data collection date for primary outcome measure)

Eligibility 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 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

• Sexes Eligible for Study: All

• Ages: 12 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04691557
• Other Study ID Numbers: 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

• 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: Akdeniz University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Aysegul ISLER DALGIC, Professor; Akdeniz University
• Study Chair: Aysen BINGOL, Professor; Akdeniz University

• PRS Account: Akdeniz University
• Verification Date: May 2022