- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04840329
Endocation: Trial of an Endometriosis Education Program
February 16, 2023 updated by: Paul Yong, BC Women's Hospital & Health Centre
Endocation: A Randomized Cluster Controlled Trial of an Endometriosis Education Program for Middle and Secondary School Students
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3N1
- BC Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 8-12 grade level class
Exclusion Criteria:
- Instruction offered in a language other than English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education Arm
|
One-time educational session about menstrual health and endometriosis
|
No Intervention: Waitlist Control Arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in menstrual health and endometriosis knowledge
Time Frame: Baseline and 4 weeks
|
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
Time Frame: Baseline and 4 weeks
|
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
Time Frame: Baseline and 4 weeks
|
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
Time Frame: Baseline and 4 weeks
|
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)
Time Frame: Immediately following education in intervention and waitlist control group
|
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)
Time Frame: Immediately following education in intervention and waitlist control group
|
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
Time Frame: Baseline
|
Number of participants who refuse to participate divided by the number of participants invited to participate
|
Baseline
|
Retention of participants
Time Frame: 4 weeks
|
Number of participants completing the study divided by the number of participants enrolled
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paul Yong, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 9, 2021
Primary Completion (Actual)
May 20, 2021
Study Completion (Actual)
May 20, 2021
Study Registration Dates
First Submitted
April 7, 2021
First Submitted That Met QC Criteria
April 7, 2021
First Posted (Actual)
April 12, 2021
Study Record Updates
Last Update Posted (Estimate)
February 20, 2023
Last Update Submitted That Met QC Criteria
February 16, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H19-00978
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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