Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452407
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-05
Brief Title:
Evaluating the Feasibility of elleFA App Implementation
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Evaluating the Feasibility of elleFA App Implementation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
elleFA
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 theres currently not enough research on this disease in Canada it takes on average 54 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 apps 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
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 apps 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
Detailed Description:
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 0809 quality-adjusted life years per woman suffering from the condition Endometriosis is currently deeply under-researched diagnosis is delayed on average 54 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 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 BB 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 6-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 6-point Likert scale
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 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 BB 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 6-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 6-point Likert scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None