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

Primary Purpose

Asthma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The KmAsthma self-management smart phone app intervention
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma control, KmAsthma, Phone app, Adolescents, School, Low resource settings

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    KmAsthma self-management smart phone app intervention

    Control arm

    Arm Description

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

    Will emulate standard access to asthma self-management information

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)
    Change in AASEQ scores
    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%

    Full Information

    First Posted
    April 29, 2023
    Last Updated
    June 23, 2023
    Sponsor
    Makerere University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05850806
    Brief Title
    Effectiveness of a Self-management App in Improving the Control of Asthma Among School Adolescents
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    February 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Makerere University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Asthma control, KmAsthma, Phone app, Adolescents, School, Low resource settings

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The participants and the assessors will be masked to the study arm
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    KmAsthma self-management smart phone app intervention
    Arm Type
    Experimental
    Arm Description
    Participants assigned to the intervention arm will be given a link to download the self-management app on their Android smartphone or iPhone
    Arm Title
    Control arm
    Arm Type
    No Intervention
    Arm Description
    Will emulate standard access to asthma self-management information
    Intervention Type
    Device
    Intervention Name(s)
    The KmAsthma self-management smart phone app intervention
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in mean Asthma Control Test (ACT) scores
    Description
    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
    Time Frame
    Baseline, 3 and 6 months
    Secondary Outcome Measure Information:
    Title
    Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)
    Description
    Change in AASEQ scores
    Time Frame
    Baseline, 3 and 6 months
    Title
    Feasibility based on proportion of participants that will drop out of the study
    Description
    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%
    Time Frame
    Baseline, 3 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    James Davis Katumba, MSc
    Phone
    +256783109311
    Email
    jamesdaviskatumba@gmail.com, james.katumba@students.mak.ac.ug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James Davis Katumba, MSc
    Organizational Affiliation
    Makerere University, College of Health Sciences, Clinical Epidemiology Unit
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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 URL
    https://orcid.org/0000-0001-8617-3786
    Citations:
    PubMed Identifier
    14713908
    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.
    Results Reference
    background
    PubMed Identifier
    31048348
    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.
    Results Reference
    background
    PubMed Identifier
    29064746
    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.
    Results Reference
    result

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

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