Recruiting

elleFA

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT06452407

Conditions

Endometriosis

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Implementation of elleFA smartphone application

Study Details

Brief summary:

Endometriosis is a chronic incurable disease where endometrial-like tissue grows outside of the uterus, and causes symptoms such as debilitating menstrual pain, pain during intercourse, infertility, constipation, and bloating, which hurts their quality of life. Endometriosis is estimated to affect approximately 10% of women. Despite this, there's currently not enough research on this disease; in Canada it takes on average 5.4 years to get a diagnosis (from when symptoms start), and once diagnosed, women often have to go through a trial-and-error process to find a treatment that can manage their symptoms. Misunderstanding symptoms and struggling with patient-provider communication both contribute to these delays in diagnosis and finding the best treatment.

Mobile health applications have been a promising new tool to self-track symptoms and treatments. There are several apps currently available on the market for logging chronic pain, menstrual cycles, and fertility. However, no apps exist specifically for endometriosis that look at the whole spectrum of symptoms, including pain, quality of life, and especially ease of patient-provider communication. The elleFA app is a new, personal endometriosis and health tracking app designed to improve patient-physician dialogue through more direct, efficient, and impactful communication, as patients navigate their condition.

This single-arm interventional study aims to test the feasibility of implementing the new elleFA app in a clinical setting for 6 months in pre-menopausal women 18 years and older with endometriosis, and the app's impact on patient experience. Participants will download the elleFA app on their smartphone and will be asked to complete two questionnaires through the app every month for 6 months. Participants can choose to also optionally track their daily symptoms, lifestyle, and treatments, through weekly symptom log summaries through the app.

The main study finding will be be patient adherence to using the app over a 6 month study period. Other findings will include user-reported satisfaction with the elleFA app, and the impact of elleFA app use on patient experience communicating with their healthcare team.

Conditions

Endometriosis

Study ID

NCT06452407

Start date

Dec 16, 2025

Status verified date

Sep, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pre-menopausal women 18 years of age or older with known or suspected endometriosis
  • Undergoing medical management of endometriosis at the MUHC
  • Able to provide informed consent in French or in English

Exclusion Criteria:

  • Menopausal status
  • Pregnant or seeking pregnancy

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Implementation of elleFA smartphone application

Implementation of the elleFA smartphone application to track symptoms, lifestyle, treatments and any patient-defined endpoints.

Interventions

Implementation of elleFA smartphone application

Participants will download the elleFA application on their smartphone. Through this application, the user will be prompted to complete a short modified Biberoglu and Behrman (B\&B) questionnaire and a longer EHP-30 questionnaire monthly, for a period of 6 months. Optionally, patients may complete an additional weekly summary of their mental health symptoms, pain localization, and other symptoms. Also optionally, they may record any daily symptoms, separated into categories from lifestyle to physical pain, objectified through a 5-point Likert scale.

Primary outcome measure

  • patient adherence to using the app [ Time Frame: 6-months following trial commencement ]

Central Contacts and Locations

Central contacts

Locations

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Jan 20, 2026

Last verified

Sep, 2025

Keywords

  • mobile health application
  • app
  • symptom tracking
  • treatment tracking
  • self-tracking
  • pain
  • quality of life
  • patient-provider communication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-01-20.