Improving women's health with a digitally supported healthcare model for girls and young women with menstrual pain - nested randomized controlled trial

Not Applicable

Recruiting

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

Registration Number: DRKS00033614

Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 220

Inclusion Criteria

at least two menstrual bleedings in the last three months;
- most severe menstrual pain in the last three months is = 6 on the NRS (without pain medication);
- most severe menstrual pain with pain medication in the last three months is = 4 on the NRS;
- Currently no long-term hormonal treatment;
- Informed consent;
- own smartphone (iOS or Android) and consent 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

- Current pregnancy or pregnancy planned in the next 12 months;
- irregular menstruation;
- Existing gynecological diagnosis, which 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 after 6 months (week 21-24 of the RCT), measured with the app diary.

Secondary Outcome Measures

Name	Time	Method
Characterization of the study population, pain intensity [VAS 0-10], number of associated symptoms, number of days with pain medication, pain medication consumption [tablets per day], pain-specific self-efficacy (FESS), quality of life (EQ-5D-5L), health state [NRS 0-100], performance [NRS 0-10], absenteeism [number of days], presenteeism [number of days] at baseline and every 3 months, health economic parameters/ICER, endometriosis risk, use of app functions, number of suspected side effects of the app and the multimodal treatment approach, number of serious adverse events