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

Asthma Clinical Trial

— MICROS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05850806
• Other study ID #: Mak-SOMREC-2021-67
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: February 2024

Study information

• Verified date: June 2023
• Source: Makerere University
• Contact: James Davis Katumba, MSc
• Phone: +256783109311
• Email: jamesdaviskatumba[@]gmail.com, james.katumba[@]students.mak.ac.ug
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• The KmAsthma self-management smart phone app intervention
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

References & Publications (3)

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. Epu — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)	Change in AASEQ scores	Baseline, 3 and 6 months
Secondary	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