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
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 主要终点
- Change in mean Asthma Control Test (ACT) scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and the assessors will be masked to the study arm
入排标准
- 年龄范围
- 12 Years 至 19 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Schools:
- •Secondary schools in Kampala
- •School has existed for more than five years
排除标准
- •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
研究组 & 干预措施
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
干预措施: The KmAsthma self-management smart phone app intervention (Device)
Control arm
Will emulate standard access to asthma self-management information
结局指标
主要结局
Change in mean Asthma Control Test (ACT) scores
时间窗: 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
次要结局
- Feasibility based on proportion of participants that will drop out of the study(Baseline, 3 and 6 months)
- Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)(Baseline, 3 and 6 months)
