Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 10390032310035 | Other Grant/Funding Number | ZonMw |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App group | Experimental | Participants in the 'App group' arm will be asked to record their menstrual health complaints daily in the mobile menstrual tracker and education application. |
|
| Waitlist group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menstrual Tracker and Education Application | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Score | Quality of life measured at baseline and 6 months after enrollment using the validated Pediatric Quality of Life 4.0 questionnaire. | 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual bleeding related quality of life | The menstrual bleeding related quality of life assessed with the (adolescent) Menstrual Bleeding Questionnaire. The adolescent (<18) or adult version of the questionnaire will be used as appropriate. | 6, 12, 24 months after enrollment |
| Knowledge about menstrual health |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther Domenie, MSc | Contact | +31 6 23997219 | MGA-studie@amsterdamumc.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Amsterdam | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38104798 | Background | 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. | |
| 38437753 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The knowledge about menstrual health will be assessed with the Menstrual Health Literacy survey. |
| 6, 12 and 24 months after enrollment |
| School-, work-, and leisure absences | The impact of menstrual complaints on school, work and leisure activities will be measured using the iMTA Productivity Cost Questionnaire (iPCQ). Impact of menstrual complaints is also reported in the mobile menstrual tracker and education app. | 6, 12 and 24 months after enrollment |
| Societal costs | Societal costs including healthcare use and prodictivity loss will be assessed using the iMTA Productivity Cost Questionnaire (iPCQ) and the iMTA Medical Consumption Questionnaire (iMCQ). | 6, 12 and 24 months after enrollment |
| Quality of Life for cost-effectiveness calculation | To calculate the cost-effectiveness of the intervention, the quality of life assessed with the 5-level EQ-5D (EQ-5D-5L) and EQ-5D-Y-5L as appropriate as a measure for effectiveness. | 6, 12 and 24 months after enrollment |
| Participants' experience of effectiveness | The effectiveness experienced by the participant is measured using the 1-item questionnaire Patient Global Impression of Change. | 6, 12 and 24 months after enrollment |
| Dose of mobile menstrual tracking and education application | Logdata of the mobile menstrual tracking and education application will be used to calculate the dose of the intervention received. | 6, 12 and 24 months |
| Menstrual disturbance | The menstrual disturbance score assessed with the Period ImPact and Pain Assessment tool (PIPPA) | 6, 12 and 24 months after enrollment |
| 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. |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D008595 | Menorrhagia |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
Not provided
Not provided