Back to resultsMobile Health Application for Adolescents With Asthma
Primary Purpose
Adolescent, Nursing Care, Asthma in Children
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobile Health Application
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Adolescent focused on measuring Asthma Control, Nursing care, Mobile Health, Self-Efficacy, Randomized Controlled Trial, Adolescent
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
Sites / Locations
- Akdeniz University Hospital
- Antalya Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
The intervention group receives the YoungAsthma developing for the smartphone or tablet additionally usual nursing care.
The control group receives the usual nursing care.
Outcomes
Primary Outcome Measures
Self-Efficacy
Self-efficacy will be evaluated by Asthmatic Child and Adolescent Self-Efficacy Scale (ACASES) (Schlösser & Havermans, 1992).
Asthma Control
Asthma control will be evaluated by the Asthma Control Test (ACT) (Liu et al., 2007).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04691557
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
April 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 self-efficacy theory-based, 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent, Nursing Care, Asthma in Children, Self Efficacy
Keywords
Asthma Control, Nursing care, Mobile Health, Self-Efficacy, Randomized Controlled Trial, Adolescent
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A self-efficacy theory based, randomized, 4-week, parallel group study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group receives the YoungAsthma developing for the smartphone or tablet additionally usual nursing care.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group receives the usual nursing care.
Intervention Type
Other
Intervention Name(s)
Mobile Health Application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
Self-Efficacy
Description
Self-efficacy will be evaluated by Asthmatic Child and Adolescent Self-Efficacy Scale (ACASES) (Schlösser & Havermans, 1992).
Time Frame
Assessment of change of the self-efficacy from baseline to 4 weeks will be done.
Title
Asthma Control
Description
Asthma control will be evaluated by the Asthma Control Test (ACT) (Liu et al., 2007).
Time Frame
Assessment of change of the asthma control from baseline to 4 weeks will be done.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysegul ISLER DALGIC, Professor
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aysen BINGOL, Professor
Organizational Affiliation
Akdeniz University
Official's Role
Study Chair
Facility Information:
Facility Name
Akdeniz University Hospital
City
Antalya
State/Province
None Selected
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Antalya Education and Research Hospital
City
Antalya
State/Province
None Selected
ZIP/Postal Code
07058
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It has not been yet decided. After the study is finalized, the plan to share individual participant data will be done.
Learn more about this trial
Mobile Health Application for Adolescents With Asthma
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