The Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 874
- 试验地点
- 1
- 主要终点
- Quality of Life Score
研究概览
简要总结
The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.
详细描述
Studies have shown that menstrual health-related quality of life is influenced mainly by pain, blood loss and school/work/leisure absenteeism. We hypothesize that using a mHealth intervention designed for adolescents will increase the self-awareness of an adolescent's menstrual health, including adequate healthcare-seeking. As a result, the intervention will increase menstrual health-related quality of life.
Postmenarchal adolescents aged between 12 and 22 years can be included in this study and will be randomised using 1:1 stratified randomisation in the intervention arm or control arm. Stratification factors are: age (<16 of ≥ 16 years old), use of hormonal anticonception (yes or no) and menstrual disturbance score (Period ImPact and Pain Assessment score <3 or ≥3).
Participants in the intervention arm will be asked to track their menstrual complaints in the mobile menstrual tracker and education application daily for at least three months. Participants in the control arm will not use the mobile menstrual tracker and education application for six months. Participants in the control arm also get access to the mobile menstrual tracker and education application six months after enrollment and after the primary outcome measurement at 6-months after enrollment.
The primary outcome measure is quality of life, using the PedsQL measured six months after enrollment. Secondary outcomes are school, work and leisure absenteeism, menstrual careseeking behavior, knowledge about menstrual complaints, the prevalence of suspected bleeding disorders, the prevalence of menstrual disturbance, the amount of menstrual blood loss, and societal costs.
All outcomes will be measured using online questionnaires send at 6, 12 and 24 months after enrollment.
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
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Dutch, English, Turkish or Moroccan-Arabic speaking
- •Post menarche
- •Access to a smartphone or tablet with iOS or Android operating system
排除标准
- •Amenorrhea
- •Pregnancy
- •No menstrual bleeding or withdrawel bleeding in the 3 months prior to inclusion.
- •Previously or currently under treatment by a health care provider for menstrual complaints
研究组 & 干预措施
App group
Participants in the 'App group' arm will be asked to record their menstrual health complaints daily in the mobile menstrual tracker and education application.
干预措施: Menstrual Tracker and Education Application (Other)
Waitlist group
Participants in the 'waitlist group' will not directly get access to the mobile menstrual tracker and education application. They will be put on a 'waitlist'. Six months after inclusion and after completing the 6-month questionnaire, participants will get access to the application and are free to install and use it if desired.
结局指标
主要结局
Quality of Life Score
时间窗: 6 months after enrollment
Quality of life measured at baseline and 6 months after enrollment using the validated Pediatric Quality of Life 4.0 questionnaire.
次要结局
- Menstrual bleeding related quality of life(6, 12, 24 months after enrollment)
- Knowledge about menstrual health(6, 12 and 24 months after enrollment)
- School-, work-, and leisure absences(6, 12 and 24 months after enrollment)
- Societal costs(6, 12 and 24 months after enrollment)
- Quality of Life for cost-effectiveness calculation(6, 12 and 24 months after enrollment)
- Participants' experience of effectiveness(6, 12 and 24 months after enrollment)
- Dose of mobile menstrual tracking and education application(6, 12 and 24 months)
- Menstrual disturbance(6, 12 and 24 months after enrollment)
研究者
Dr. Robert A. de Leeuw
MD, PhD. Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)