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Evaluation of a Mobile Menopause Application (EMMA)

17. juni 2026 opdateret af: Endo Health GmbH
This study examines whether a digital app can help women manage symptoms of menopause. A total of 426 women with medically confirmed menopausal symptoms are randomly assigned to either use the app in addition to their usual medical care for 24 weeks, or to continue with usual care alone. The app provides evidence-based content and exercises for multimodal menopause management. Participants are followed up over 24 weeks, with the primary outcome assessed at 12 weeks. The main goal is to evaluate whether the app improves menopause-specific quality of life.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

426

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Hanover, Tyskland
        • Medicoles
        • Ledende efterforsker:
          • Elisabeth Siegmund-Schultze, Dr. med.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Legal capacity
  • Ability to provide informed consent
  • Residency in Germany
  • Female gender
  • Age ≥18 years
  • Medically confirmed menopausal or other perimenopausal disorder (N95.1)
  • Ownership of a smartphone and ability to use it
  • Internet access for app usage and questionnaire completion
  • Email address for registration
  • Willingness to complete questionnaires online
  • Motivation for regular app usage
  • Sufficient proficiency in the German language
  • MRS II ≥ 9
  • Absence of exclusion criteria

Exclusion Criteria:

  • Pregnancy or breastfeeding during the study period
  • Current hormonal replacement therapy (HRT), initiation of HRT within eight weeks prior to study start and/or planned start of HRT during the study period
  • Changes in treatment with psychotropic medication within eight weeks prior to study start and/or planned during the study period
  • Start of psychotherapy within eight weeks prior to study start and/or planned during the study period
  • Start of a rehabilitation program within eight weeks prior to study start and/or planned during the study period
  • Surgery performed within eight weeks prior to study start and/or planned during the study period
  • Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
  • Current participation in other clinical studies
  • Failure to meet the inclusion criteria

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control Group
The control group has access to care-as-usual only.
Eksperimentel: Intervention Group
The intervention group has access to the menopause app and its functions in addition to care-as-usual.
Enhed: Menopause App
The menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a menopausal disorder, through tools such as a symptom diary and guided interactive exercises.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Menopause-specific quality of life
Tidsramme: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Menopause-specific symptom severity
Tidsramme: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Assessed with the Menopause Rating Scale (MRS II)
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Daily interference due to hot flashes
Tidsramme: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Assessed with the Hot Flash Related Daily Interference Scale (HFRDIS)
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-specific impairment in daily activities
Tidsramme: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Assessed with the Activity Impairment domain of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause)
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Patient activation
Tidsramme: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Assessed with the Patient Activation Measure 13 (PAM-13)
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Menopause-specific quality of life
Tidsramme: Changes between time point T0 (baseline) and T4 (24 weeks after baseline)
Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)
Changes between time point T0 (baseline) and T4 (24 weeks after baseline)
Menopause-related absenteeism
Tidsramme: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Assessed with the absenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-related presenteeism
Tidsramme: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Assessed with the presenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-related work productivity loss
Tidsramme: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Assessed with the work productivity loss domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Endo Health GmbH

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

17. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juni 2026

Først opslået (Faktiske)

23. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • RCT_EMMA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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