N95.1
Conditions
Interventions
Group 1: Control group: Women with perimenopause/menopause (ICD10: N95.1) receive access to usual standard care.
Group 2: Intervention group: Women with perimenopause/menopause (ICD10: N95.1) receive
Sponsors
Sidekick Health ehf
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Women who are =40 to =65 years of age - Women with menopause or going through perimenopause - Have at least 5 moderate to severe self-reported hot flashes per day (including night sweats), on average per 7 days (HFRS) - Menopause rating scale (MRS, Hauser et al., 1994) score =9 (moderate symptoms) - Proficiency in the German language (written and spoken) and German residency - Ability to provide informed consent to participate in the study, understanding the risks and benefits involved - Physical and mental ability to independently implement behavioral changes and physical activity - Ability to operate a smartphone or tablet
Exclusion criteria
Exclusion criteria: - Exclusion criteria will be checked via telephone interview: - Women who are lactating, pregnant, or planning to become pregnant during the study - Women with temporary treatment-induced menopause - Use of HRTs or other pharmacological treatments for menopausal symptoms (e.g. NK3 receptor antagonists, antidepressive (SSRIs/SNRIs) or anticonvulsive medication) at the time of recruitment or within 6 months prior to study start - Women planning to start menopause-related pharmacological treatment (see above) during the study or for whom significant changes in current pharmacological treatment are already planned - Women who are currently undergoing psychotherapy or who are planning to start psychotherapy during the study phase - Women currently undergoing cancer therapy or having received cancer therapy in the last 6 months - Use of other digital interventions aiming to reduce climacteric symptoms - Participation in other clinical trials currently or during the last 6 months - Medical or mental condition that, in the PI's opinion, will make it impossible for the patient to independently complete questionnaires or follow guidelines and instructions in line with the study protocol - Unwillingness to complete study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is change in menopause-specific quality of life after 12 weeks (MenQoL, one week recall version). The endpoint will be patient-reported and collected online through an electronic Case Report Form (eCRF) at the start of the study (T0), after 6 weeks (T1), and after 12 weeks (T2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will be assessed collected online through an electronic Case Report Form (eCRF) using validated questionnaires at baseline (T0) and 12 weeks (T2): Change in the frequency of vasomotor symptoms (VMS) (Hot Flush Rating Scale, HFRS), after 12 weeks Change in the problem rating of vasomotor symptoms (HFRS) after 12 weeks Change in sleep quality (Insomnia Severity Index – 2-week version) after 12 weeks Change in depression, anxiety and stress scale (DASS-21) after 12 weeks Change in health literacy (European Health Literacy Survey Questionnaire-16, HLS-EU-Q16) | — |
Countries
Germany
Contacts
Public ContactNele Freerksen-Kirschner
Frauenklinik für Gynäkologie und Geburtsmedizin Universitätsklinikum Aachen
Outcome results
None listed