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

Not Applicable

Recruiting

Conditions: N94.4
N94.6
Dysmenorrhoea, unspecified
Primary dysmenorrhoea

Registration Number: DRKS00033626

Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 3000

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber 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 Outcome Measures

Name	Time	Method
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 after 3, 9, and 15 months, Health economic parameters/ICER, endometriosis risk, use of app features, number of suspected app side effects, number of serious adverse events.<br>Endpoints are collected through the app diary function as well as through questionnaires in the app after 3, 9, and 15 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.