The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis.

NCT06821217 | Recruiting DMC

• 1 other identifier: 2023-D0105
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are:

• Does the App-based intervention improve the quality of life?
• Does it lead to pain relief? Researchers will compare participants using the App to a control group to see if the App works to improve quality of life and endometriosis-related symptoms. Participants will:
• Use an App-based intervention or be in the control group (no App-use) for 6 months
• Visit or have a telephone consultation after 3 and 6 months
• Complete a questionnaire to assess the quality of life at inclusion, after 1, 3 and 6 months

Conditions

Endometriosis; Pain; Quality of Life; Life Style

Outcome Measures

Primary Outcomes (1)

• Life quality

  The primary endpoint will be the change in quality of life in App users assessed by the EHP-30 questionnaire (Endometriosis-Health-Profile-Questionnaire: The questions can be divided into five subscales covering 'pain', 'control and powerlessness', 'social support', 'emotional wellbeing' and 'self-image'. The questionnaire is standardized on a scale from 0 to 100, with lower scores indicating better quality of life.

  6 months

Secondary Outcomes (1)

• Pain relief

  6 months

Study Arms (4)

Intervention group with histologically confirmed endometriosis

EXPERIMENTAL

Device: NALU Endo Flow App

Control group with histologically confirmed endometriosis

NO INTERVENTION

Intervention group with clinically suspected endometriosis

EXPERIMENTAL

Device: NALU Endo Flow App

Control group with clinically suspected endometriosis

NO INTERVENTION

Interventions

NALU Endo Flow App DEVICE

NALU Endo Flow App is a mobile application for women with endometriosis. The App provides educational information through videos, audios, and texts. Women learn about endometriosis in general with its symptoms, diagnosis, and therapy options such as lifestyle and mindset modification, endometriosis-specific diets, physical and mindfulness exercises. The App includes a diary to track the menstrual cycle and symptoms. Furthermore, access to a WhatsApp community of people with endometriosis is provided and a peer-group call is performed once monthly, as well as one additional monthly Q\&A (Question\&Answer) call moderated by certified health coaches.

Intervention group with clinically suspected endometriosis; Intervention group with histologically confirmed endometriosis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature
• Age 18 or older
• Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
• Endometriosis, confirmed by surgery or clinically suspected
• Possession of a smartphone

You may not qualify if:

• Planned endometriosis surgery or planned hormonal therapy in the study period
• Surgery and/or new hormonal therapy in the last three months
• Malignant diseases
• Pregnancy
• Breastfeeding
• Active desire for pregnancy in the study period
• Fertility treatment
• Simultaneous participation in other intervention studies

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Endometriosis; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marietta Gulz, MD

  University Hospital Bern, Insel Gruppe AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marietta Gulz, MD

CONTACT

+41 31 632 10 10; marietta.gulz@insel.ch

Michael David Mueller, Professor, MD

CONTACT

michel.mueller@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)