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

NCT05850806 | Unknown DMC

• 1 other identifier: Mak-SOMREC-2021-67
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Asthma control; KmAsthma; Phone app; Adolescents; School; Low resource settings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)

  Baseline, 3 and 6 months

• Feasibility based on proportion of participants that will drop out of the study

  Baseline, 3 and 6 months

Study Arms (2)

KmAsthma self-management smart phone app intervention

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Will emulate standard access to asthma self-management information

Interventions

The KmAsthma self-management smart phone app intervention 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

KmAsthma self-management smart phone app intervention

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Schools already participating in an asthma related randomised controlled trial
• years
• Day scholar student
• Uncontrolled asthma on assessment using Asthma Control Test (ACT score less than 19)
• Self-reported access to a smart phone
• Students already taking part in an asthma-related randomised controlled trial
• Too sick to use the smart phone

Sponsors & Collaborators

• Makerere University: lead

Related Publications (4)

• 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.

  PMID: 14713908 BACKGROUND

• 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.

  PMID: 31048348 BACKGROUND

• 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.

  PMID: 29064746 RESULT

• 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.

  PMID: 38053534 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• James Davis Katumba, MSc

  Makerere University, College of Health Sciences, Clinical Epidemiology Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Davis Katumba, MSc

CONTACT

+256783109311; jamesdaviskatumba@gmail.com, james.katumba@students.mak.ac.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the assessors will be masked to the study arm
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 9, 2023
• Study Start: July 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication
• Access Criteria: Data available indefinitely at the link that will be added