Clinical trial NCT05850806: Effectiveness of a Self-management App in Improving the Control of Asthma Among School 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Asthma control
KmAsthma
Phone app
Adolescents
School
Low resource settings
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 66
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in mean Asthma Control Test (ACT) scores
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)
timeFrame: Baseline, 3 and 6 months
measure: Feasibility based on proportion of participants that will drop out of the study
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Makerere University, College of Health Sciences, Clinical Epidemiology Unit
name: James Davis Katumba, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
citation: Holley S, Knibb R, Latter S, Liossi C, Mitchell F, Radley R, Roberts G. Development and validation of the Adolescent Asthma Self-Efficacy Questionnaire (AASEQ). Eur Respir J. 2019 Jul 4;54(1):1801375. doi: 10.1183/13993003.01375-2018. Print 2019 Jul.
citation: Davis SR, Peters D, Calvo RA, Sawyer SM, Foster JM, Smith L. "Kiss myAsthma": Using a participatory design approach to develop a self-management app with young people with asthma. J Asthma. 2018 Sep;55(9):1018-1027. doi: 10.1080/02770903.2017.1388391. Epub 2017 Nov 28.