Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Adolescent Nursing Care Asthma in Children Self Efficacy Other: Mobile Health Application Other: Usual Care Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
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
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
Actual Study Start Date : December 1, 2021
Actual Primary Completion Date : April 29, 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Intervention Group
The intervention group receives the YoungAsthma developing for the smartphone or tablet additionally usual nursing care.
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.

Active Comparator: Control Group
The control group receives the usual nursing care.
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.




Primary Outcome Measures :
  1. 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).

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691557


Locations
Layout table for location information
Turkey
Akdeniz University Hospital
Antalya, None Selected, Turkey, 07058
Antalya Education and Research Hospital
Antalya, None Selected, Turkey, 07058
Sponsors and Collaborators
Akdeniz University
Investigators
Layout table for investigator information
Study Director: Aysegul ISLER DALGIC, Professor Akdeniz University
Study Chair: Aysen BINGOL, Professor Akdeniz University
Layout table for additonal information
Responsible Party: Nimet KARATAS, Research Assistant, Akdeniz University
ClinicalTrials.gov Identifier: NCT04691557    
Other Study ID Numbers: 2012KAEK20
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nimet KARATAS, Akdeniz University:
Asthma Control
Nursing care
Mobile Health
Self-Efficacy
Randomized Controlled Trial
Adolescent
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases