elleFA App for Endometriosis

(elleFA Trial)

Overseen By Cassandra Della Rocca, BSc

Age: 18+

Sex: Female

Trial Phase: Academic

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

Disqualifiers: Menopausal, Pregnant, Seeking pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app called elleFA for women with endometriosis. The goal is to determine if the app improves communication with doctors and eases condition management. Participants will use the app to track symptoms and complete monthly questionnaires for six months. Women with endometriosis who are currently receiving treatment may be suitable for this study. The trial will assess how often participants use the app and their satisfaction with it. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the daily management of endometriosis.

Do I need to stop my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications. It seems focused on using an app to track symptoms and improve communication with your healthcare team.

What prior data suggests that the elleFA app is safe for use in endometriosis patients?

Research has shown that mobile health apps, such as the elleFA app, are generally safe for users. The elleFA app is a digital tool that tracks endometriosis symptoms and enhances communication with doctors. It does not involve medication or medical procedures, so it carries no physical side effects or risks like those associated with new medical treatments.

Studies on health tracking apps in other areas have shown they are usually well-tolerated. Users might find it slightly inconvenient to enter data or encounter technical issues, but these are not harmful. The elleFA app aims to simplify managing endometriosis, focusing on user experience and satisfaction without physical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the elleFA App for endometriosis because it offers a unique, personalized approach to managing the condition. Unlike traditional treatments, which often focus on medication or surgery, this app empowers users by allowing them to track their symptoms, lifestyle, and treatments in real-time. This can lead to more informed discussions with healthcare providers and potentially more tailored treatment plans. By putting data directly into patients' hands, the app aims to enhance patient engagement and improve overall management of endometriosis.

What evidence suggests that the elleFA app is effective for improving patient-provider communication in endometriosis?

Research shows that apps can help women with endometriosis feel better. Studies on similar apps, such as the Endo-App, have found that they can reduce both physical and emotional symptoms. Users of these apps often feel more confident in managing their condition. In this trial, participants will use the elleFA app, which aims to offer similar benefits by helping users track their symptoms and communicate better with their doctors. While specific results for elleFA are still being collected, early signs from similar apps suggest it could improve patient experiences. ^{1 2 6 7 8}

Who Is on the Research Team?

Andrew Zakhari, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women over 18 with endometriosis who are receiving treatment at MUHC and can consent in English or French. It's not suitable for those unable to use the elleFA app or participate fully.

Inclusion Criteria

I am currently being treated for endometriosis at the MUHC.

I can give my consent in English or French.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Participants download the elleFA app and complete two questionnaires monthly for 6 months

6 months

Monthly virtual check-ins via app

Follow-up

Participants are monitored for adherence and satisfaction with the app, and impact on patient-provider communication

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• elleFA App

Trial Overview The study tests the elleFA smartphone app designed to track endometriosis symptoms, improve patient-physician communication, and enhance overall management of the condition over a period of 6 months.

How Is the Trial Designed?

Group I: Implementation of elleFA smartphone application Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06452407

Evaluating the Feasibility of elleFA App Implementation The primary outcome will be patient adherence to using the app as defined by the completion rate of monthly modified Biberoglu and Behrman (B&B) scale and ...

2. withpower.com withpower.com/trial/phase-endometriosis-7-2024-a4f25

elleFA App for Endometriosis Trial Overview The study tests the elleFA smartphone app designed to track endometriosis symptoms, improve patient-physician communication, and enhance overall ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9352729/

Clinical use of artificial intelligence in endometriosis This literature review explored the use of AI methods to address different clinical problems in endometriosis.

4. link.springer.com link.springer.com/article/10.1007/s00404-024-07468-4

Observational pilot study on the influence of an app-based ... In summary, the results indicate that the quality of life of women with endometriosis improved by the digital self-management tool Endo-App®.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39314601/

Influence of App-Based Self-Management on the Quality ... Conclusion: In summary, the Endo-App improves both physical and psychological symptoms and the patient's self-efficacy. The Endo-App contributes ...

6. healthinformaticsjournal.com healthinformaticsjournal.com/downloads/files/416.pdf

Identifying required data elements for designing mobile- ... Therefore, 125 elements were verified as required data for designing endometriosis self-care app. Among the items of EHR category, three items including age ...

7. researchgate.net researchgate.net/publication/370853586_Identifying_Required_Data_Elements_for_Designing_A_Mobile-Based_Application_for_Self-Care_of_Women_Living_with_Endometriosis

Identifying Required Data Elements for Designing A Mobile ... This study aimed to extract the requirements for developing a mobile-based app for self-care of endometriosis patients through an overview of ...

8. clinicaltrials.gov clinicaltrials.gov/show/NCT05528601

NCT05528601 | Influence of an App on Quality of Life of ... The aim of this study was to examine whether there is evidence of beneficial effects of the Endo-App and whether a multicenter randomized controlled trial ...