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

NCT ID: NCT05850806

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-02-29

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

KmAsthma self-management smart phone app intervention

Participants assigned to the intervention arm will be given a link to download the self-management app on their Android smartphone or iPhone

Group Type: EXPERIMENTAL

The KmAsthma self-management smart phone app intervention

Intervention Type: DEVICE

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

Control arm

Will emulate standard access to asthma self-management information

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Secondary schools in Kampala
• School has existed for more than five years

• 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

• Schools already participating in an asthma related randomised controlled trial

• Students already taking part in an asthma-related randomised controlled trial
• Too sick to use the smart phone

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Davis Katumba, MSc

Role: PRINCIPAL_INVESTIGATOR

Makerere University, College of Health Sciences, Clinical Epidemiology Unit

Central Contacts

James Davis Katumba, MSc

Role: CONTACT

jamesdaviskatumba@gmail.com, james.katumba@students.mak.ac.ug

+256783109311

References

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.

Reference Type: BACKGROUND

PMID: 14713908 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31048348 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29064746 (View on PubMed)

Katumba JD, Kirenga B, Muwagga Mugagga A, Kalyango JN, Nantanda R, Karamagi C. MICROS: Asthma Control App for School Adolescents in a Low Resource Setting - A Cluster Randomized Controlled Trial Protocol. Patient Prefer Adherence. 2023 Nov 30;17:3125-3133. doi: 10.2147/PPA.S438549. eCollection 2023.

Reference Type: DERIVED

PMID: 38053534 (View on PubMed)

Other Identifiers

Mak-SOMREC-2021-67

Identifier Type: -

Identifier Source: org_study_id