The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
NALU Endo Flow App
DeviceNALU 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.
Treatment groups
308 Participants
are divided into 4 treatment groupsGroup A: Intervention group with histologically confirmed endometriosisExperimental treatment 1 intervention
Group B: Control group with histologically confirmed endometriosisNo intervention 0 interventions
Group C: Intervention group with clinically suspected endometriosisExperimental treatment 1 intervention
Group D: Control group with clinically suspected endometriosisNo intervention 0 interventions
Trial outcomes
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.
Time frame
6 monthsSecondary outcomes
1
Pain relief
The secondary endpoint of this study is the change in pain intensity in App users measured by the VAS (Visual Analogue Scale). The VAS is one of various instruments to measure pain intensity. A score of 0 means "no pain", a score of 10 "the worst imaginable pain".
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov