Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Menstrual Tracker and Education Application.
- Кому может быть актуально
- Состояния в реестре: Dysmenorrhea, Heavy Menstrual Bleeding, Menstrual Cramps, Menstrual Bleeding, Heavy. Базовые параметры: 12 лет — 21 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents - A Randomised Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Menstrual Tracker and Education Application
The intervention is a mobile menstrual tracker and education application developed by Amsterdam UMC researchers. The app is developed to provide insight into the users' menstrual health and contains 11 trackable domains (menstrual bleeding, pain, impact, general health, mood, urine/stool, sleep, exercise, diet, sex, notes). It is connected to an online environment where the user gets educated about normal and abnormal menstrual health.
Первичные конечные точки
- Quality of Life Score [Срок оценки: 6 months after enrollment]
Вторичные конечные точки (8)
- Menstrual bleeding related quality of life [Срок оценки: 6, 12, 24 months after enrollment]
- Knowledge about menstrual health [Срок оценки: 6, 12 and 24 months after enrollment]
- School-, work-, and leisure absences [Срок оценки: 6, 12 and 24 months after enrollment]
- Societal costs [Срок оценки: 6, 12 and 24 months after enrollment]
- Quality of Life for cost-effectiveness calculation [Срок оценки: 6, 12 and 24 months after enrollment]
- Participants' experience of effectiveness [Срок оценки: 6, 12 and 24 months after enrollment]
- Dose of mobile menstrual tracking and education application [Срок оценки: 6, 12 and 24 months]
- Menstrual disturbance [Срок оценки: 6, 12 and 24 months after enrollment]
Критерии участия
Критерии включения
- Dutch, English, Turkish or Moroccan-Arabic speaking
- Post menarche
- Access to a smartphone or tablet with iOS or Android operating system
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Нидерланды · 1 центр
- Amsterdam UMC — Amsterdam
Публикации
- Ozcan H, Burger NB, Dulmen-den Broeder EV, van Baal MW, den Boogaard EV, De Leeuw RA, Huirne JAF. Instruments to Identify Menstrual Complaints and Their Impact on Adolescents: A Systematic Review. J Pediatr Adolesc Gynecol. 2024 Apr;37(2):106-120. doi: 10.1016/j.jpag.2023.11.011. Epub 2023 Dec 16. PMID 38104798
- Ozcan H, Burger NB, Derksen ME, Peute LW, Huirne JAF, De Leeuw RA. The differences between adults and adolescents using a mobile health application for menstrual complaints: A usability and qualitative study. Int J Med Inform. 2024 May;185:105382. doi: 10.1016/j.ijmedinf.2024.105382. Epub 2024 Feb 23. PMID 38437753
Идентификаторы
NCT: NCT07457957 · MGA-studie · 10390032310035