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

June 23, 2023 updated by: Makerere University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
No Intervention: Control arm
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
Time Frame: Baseline, 3 and 6 months
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)
Time Frame: Baseline, 3 and 6 months
Change in AASEQ scores
Baseline, 3 and 6 months
Feasibility based on proportion of participants that will drop out of the study
Time Frame: Baseline, 3 and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Investigators

  • Principal Investigator: James Davis Katumba, MSc, Makerere University, College of Health Sciences, Clinical Epidemiology Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

April 29, 2023

First Submitted That Met QC Criteria

April 29, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mak-SOMREC-2021-67

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the individual participant data collected after de-identification.

IPD Sharing Time Frame

Immediately following publication

IPD Sharing Access Criteria

Data available indefinitely at the link that will be added

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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