Evaluating the Feasibility of elleFA App Implementation

Endometriosis is a chronic incurable disease where endometrial-like tissue grows outside of the uterus and is estimated to affect 10% of women of reproductive age. Many women with endometriosis experience symptoms including but not limited to debilitating menstrual pain, pain during intercourse, infertility, constipation, and bloating. Their quality of life is severely hindered, with an average of 0.809 quality-adjusted life years per woman suffering from the condition. Endometriosis is currently deeply under-researched; diagnosis is delayed on average 5.4 years from the onset of symptoms in Canada, and once diagnosed, women often have to undergo a trial-and-error approach to find treatment strategies to manage their symptoms. Misunderstanding symptoms for common menstrual pains as well as struggles in patient-provider communication in the form of physician dismissal or patient recall bias and memory gaps contribute to these delays in diagnosis and appropriate treatments.

Mobile health applications have been a promising new tool to self-track symptoms and treatments. Women report being motivated to use this mode of tracking to better manage their symptoms and improve communication with their healthcare providers. There are several apps currently available on the market for logging chronic pain, menstrual cycles, and fertility. However, endometriosis patients report feeling limited by these apps, as 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. Therefore, in this pilot study, we propose determining the feasibility of introducing the novel elleFA app in the clinical setting, a 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 6-month prospective open-label single-arm interventional clinical study aims to test the feasibility of implementing the elleFA app for 6 months in women with endometriosis, and its impact on patient experience. Twenty pre-menopausal women 18 years or older with suspected or confirmed endometriosis will be recruited. Upon recruitment, each participant will fill out a brief demographic questionnaire, then download the elleFA app on their smartphone and will be asked to complete two validated questionnaires monthly, for 6 months. Daily symptom, lifestyle, and treatment tracking, as well as weekly symptom log summaries, are available for optional completion by the participant.

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 Endometriosis Health Profile (EHP-30) surveys over a 6 month study period. One secondary outcome will be reported user satisfaction with the elleFA app itself, measured by score of patient-reported questionnaire designed to capture the user experience and perceived app functionality using a 5-point Likert scale. Another secondary outcome will be the impact of elleFA app use on patient experience communicating with the healthcare team, measured by factors such as confidence in recall or comfort with the physician-patient relationship using a 5-point Likert scale.

• Patient reported satisfaction with the app experience [Time frame: 6-months following trial commencement]
• Patient reported satisfaction with communication with the treating physician [Time frame: 6-months following trial commencement]