Evaluating the Feasibility of elleFA App Implementation

NCT06452407 | Recruiting

• 1 other identifier: 2025-10774
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• patient adherence to using the app

  Completion rate of monthly modified Biberoglu and Behrman (B\&B) scale and Endometriosis Health Profile (EHP-30) surveys over a 6 month study period, retrieved electronically.

  6-months following trial commencement

Secondary Outcomes (2)

• Patient reported satisfaction with the app experience

  6-months following trial commencement

• Patient reported satisfaction with communication with the treating physician

  6-months following trial commencement

Study Arms (1)

Implementation of elleFA smartphone application

EXPERIMENTAL

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

Other: Implementation of elleFA smartphone application

Interventions

Implementation of elleFA smartphone application OTHER

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.

Implementation of elleFA smartphone application

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Menopausal status
• Pregnant or seeking pregnancy

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Endometriosis; Alzheimer Disease; Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Zakhari, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Zakhari, MD

CONTACT

514-934-1934; andrew.zakhari@mcgill.ca

Cassandra Della Rocca, BSc

CONTACT

cassandra.dellarocca@rimuhc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: December 16, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-09

Locations

CA (1)