Improving women's health with a digitally supported healthcare model for girls and young women with menstrual pain - observational study

Improving women's health with a digitally supported healthcare model for girls and young women with menstrual pain - observational study - MeMäF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033626

Enrollment

3000

Registered

2024-02-26

Start date

2024-03-08

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N94.4 N94.6

Interventions

Group 1: Girls and young women receive the project app "period." certified as a medical device and can use it for up to 21 months. The app provides information (menstruation cycle, causes of menstrual

Eligibility

Sex/Gender

Female

Age

16 Years to 24 Years

Inclusion criteria

Inclusion criteria: - at least 3 menstrual bleeding periods during the past 6 months - Menstrual pain with at least 3 menstrual periods with at least 1x pain = 6 on the numerical rating scale (NRS) during the past 6 months ; - Informed consent; - own smartphone (iOS or Android) and be willing to enter data via an app; - consent to participate in special care in accordance to §140a SGB V (contract with own statutory health insurance company: BARMER, DAK-Gesundheit, TK)

Exclusion criteria

Exclusion criteria: - Existing pregnancy or pregnancy planned in the next 12 months; - Irregular menstruation; - Existing gynecological diagnosis that could be the cause of the menstrual pain

Design outcomes

Primary

Measure	Time frame
Number of days with menstrual pain in the past month (defined as 28 days) after 6 months (week 21-24) measured with the app diary.	—

Secondary

Measure	Time frame
Characterization of the study population, pain intensity [VAS 0-10], number of accompanying symptoms, number of days with pain medication intake, pain medication consumption [tablets per day], pain-specific self-efficacy (FESS), quality of life (EQ-5D-5L), health status [NRS 0-100], performance capacity [NRS 0-10], absenteeism [number of days], presenteeism [number of days] at baseline and every 3 months up to 21 months, Health economic parameters/ICER, endometriosis risk, use of app features, number of suspected app side effects, number of serious adverse events. Endpoints are collected through the app diary function as well as through questionnaires in the app every 3 months up to 21 months. In addition, routine data from health insurance companies are included. Furthermore, qualitative interviews on the new care model are conducted with 10-20 study participants and healthcare providers.	—

Measure

Time frame

Characterization of the study population, pain intensity [VAS 0-10], number of accompanying symptoms, number of days with pain medication intake, pain medication consumption [tablets per day], pain-specific self-efficacy (FESS), quality of life (EQ-5D-5L), health status [NRS 0-100], performance capacity [NRS 0-10], absenteeism [number of days], presenteeism [number of days] at baseline and every 3 months up to 21 months, Health economic parameters/ICER, endometriosis risk, use of app features, number of suspected app side effects, number of serious adverse events. Endpoints are collected through the app diary function as well as through questionnaires in the app every 3 months up to 21 months. In addition, routine data from health insurance companies are included. Furthermore, qualitative interviews on the new care model are conducted with 10-20 study participants and healthcare providers.

—

Countries

Germany

Contacts

Public ContactDaniel Pach

Charité - Universitätsmedizin Berlin, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie

daniel.pach@charite.de+49 30 450 529068

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026