Endocation: Trial of an Endometriosis Education Program

Study Overview
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Brief Summary
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Endometriosis is a common condition that affects 10% of females, causing chronic pain and other health concerns. Currently, it takes 8-12 years to be diagnosed with endometriosis, in part because there is low awareness of this condition. This research is designed to test whether providing endometriosis education in schools can help increase early awareness of the condition.

Official Title
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Endocation: A Randomized Cluster Controlled Trial of an Endometriosis Education Program for Middle and Secondary School Students

Conditions
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Endometriosis

Intervention / Treatment
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* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8-12 grade level class Exclusion Criteria: Instruction offered in a language other than English
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education Arm<br> | Behavioral: Education<br>* One-time educational session about menstrual health and endometriosis<br>|
| No Intervention: Waitlist Control Arm<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in menstrual health and endometriosis knowledge | Assessed using a built for purpose questionnaire, possible scores range from 0 to 8 | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in prioritization of menstrual health | Assessed using a built for purpose item, possible scores range from 0 to 4 | Baseline and 4 weeks | 
| Change from baseline in confidence in endometriosis knowledge | Assessed using a built for purpose item, possible scores range from 0 to 4 | Baseline and 4 weeks | 
| Change from baseline in comfort with menstrual health | Assessed using a built for purpose item, possible scores range from 0 to 4 | Baseline and 4 weeks | 
| Acceptability of menstrual health and endometriosis education (quantitative) | Assessed using a built for purpose questionnaire, possible scores range from 0 to 35 | Immediately following education in intervention and waitlist control group | 
| Acceptability of menstrual health and endometriosis education (qualitative) | Assessed using open-ended responses a built for purpose questionnaire | Immediately following education in intervention and waitlist control group | 
| Refusal of participants invited to participate | Number of participants who refuse to participate divided by the number of participants invited to participate | Baseline | 
| Retention of participants | Number of participants completing the study divided by the number of participants enrolled | 4 weeks |