Effectiveness of a Self-management App in Improving the Control of Asthma Among School Adolescents

Study Overview
=================
Brief Summary
-----------------
Uganda experiences high morbidity and costs due to uncontrolled asthma. Poor asthma control in adolescents is partly attributed to inadequate asthma education; indicating that education and self-management programs are essential components of asthma control. Adolescents with poorly controlled asthma are reported to have improved asthma control after using a smart phone application in outpatient setting studies. However, there is paucity of data on the effectiveness, feasibility and acceptability of smart phone applications in the control of asthma among adolescent secondary school students in low resource settings.

Detailed Description
-----------------
Uganda experiences high morbidity and costs due to uncontrolled asthma. Poor asthma control in adolescents is partly attributed to inadequate asthma education; indicating that education and self-management programs are essential components of asthma control. Adolescents with poorly controlled asthma are reported to have improved asthma control after using a smart phone application in outpatient setting studies. However, there is paucity of data on the effectiveness, feasibility and acceptability of smart phone applications in the control of asthma among adolescent secondary school students in low resource settings. This study will evaluate the effectiveness, acceptability and feasibility of the KmAsthma self-management app in improving the control of asthma among day scholar secondary school adolescents in Kampala City Uganda. This study is a 6-month cluster randomized, controlled, single-centre, single-blinded, pragmatic parallel trial, with two arms and a primary endpoint of improving the control of uncontrolled asthma measured as change in individual mean scores on the Asthma control questionnaire during a self-management intervention delivered by the KmAsthma smartphone app. The study will compare students with uncontrolled asthma in the intervention group using the KmAsthma smartphone app (T) with the students in the control arm (C) who will receive no intervention. Data will be analysed by summarizing descriptive statistics; determining odds ratios for asthma control using logistic regression models, using repeated measures ANCOVA for repeated continuous measurements. Permission from CEU and approval from SOMREC and UNCST will be sought. Informed and written consent and assent will sought. Dissemination will be through publications and presentations in local and international conferences. The findings may contribute to filling the gap leading to overall unsatisfactory asthma control in adolescents.

Official Title
-----------------
Effectiveness, Acceptability and Feasibility of KmAsthma Self-management App in iMprovIng the ContRol Of aSthma (MICROS) Among Day Scholar Secondary School Adolescents in Kampala City Uganda: A Cluster Randomised Controlled Trial

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Device: The KmAsthma self-management smart phone app intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Schools: Secondary schools in Kampala School has existed for more than five years Exclusion criteria for schools: Schools already participating in an asthma related randomised controlled trial Inclusion criteria for students: 12-19 years Day scholar student Uncontrolled asthma on assessment using Asthma Control Test (ACT score less than 19) Self-reported access to a smart phone Exclusion criteria for students: Students already taking part in an asthma-related randomised controlled trial Too sick to use the smart phone

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KmAsthma self-management smart phone app intervention<br>Participants assigned to the intervention arm will be given a link to download the self-management app on their Android smartphone or iPhone | Device: The KmAsthma self-management smart phone app intervention<br>* KmAsthma is a free app which enables users to track their symptoms, access their action plan, learn about asthma and set goals to make change<br>|
| No Intervention: Control arm<br>Will emulate standard access to asthma self-management information | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Asthma Control Test (ACT) scores | The ACT questionnaire is composed of five questions, each scored on a scale from 1 to 5, with a total score range of 5 to 25. A score of 19 or above is considered indicative of well-controlled asthma | Baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent Asthma Self-Efficacy Questionnaire (AASEQ) | Change in AASEQ scores | Baseline, 3 and 6 months | 
| Feasibility based on proportion of participants that will drop out of the study | Deemed feasible if the percentage of participants who drop out of the study (i.e., fail to complete any of the tools) is less than 15% | Baseline, 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma control, KmAsthma, Phone app, Adolescents, School, Low resource settings