Back to resultsEndocation: Trial of an Endometriosis Education Program
Primary Purpose
Endometriosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Education
Sponsored by
About this trial
This is an interventional other trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- 8-12 grade level class
Exclusion Criteria:
- Instruction offered in a language other than English
Sites / Locations
- BC Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Education Arm
Waitlist Control Arm
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in menstrual health and endometriosis knowledge
Assessed using a built for purpose questionnaire, possible scores range from 0 to 8
Secondary Outcome Measures
Change from baseline in prioritization of menstrual health
Assessed using a built for purpose item, possible scores range from 0 to 4
Change from baseline in confidence in endometriosis knowledge
Assessed using a built for purpose item, possible scores range from 0 to 4
Change from baseline in comfort with menstrual health
Assessed using a built for purpose item, possible scores range from 0 to 4
Acceptability of menstrual health and endometriosis education (quantitative)
Assessed using a built for purpose questionnaire, possible scores range from 0 to 35
Acceptability of menstrual health and endometriosis education (qualitative)
Assessed using open-ended responses a built for purpose questionnaire
Refusal of participants invited to participate
Number of participants who refuse to participate divided by the number of participants invited to participate
Retention of participants
Number of participants completing the study divided by the number of participants enrolled
Full Information
NCT ID
NCT04840329
First Posted
April 7, 2021
Last Updated
February 16, 2023
Sponsor
BC Women's Hospital & Health Centre
Collaborators
BC Support Unit
1. Study Identification
Unique Protocol Identification Number
NCT04840329
Brief Title
Endocation: Trial of an Endometriosis Education Program
Official Title
Endocation: A Randomized Cluster Controlled Trial of an Endometriosis Education Program for Middle and Secondary School Students
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
May 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
BC Women's Hospital & Health Centre
Collaborators
BC Support Unit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education Arm
Arm Type
Experimental
Arm Title
Waitlist Control Arm
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
One-time educational session about menstrual health and endometriosis
Primary Outcome Measure Information:
Title
Change from baseline in menstrual health and endometriosis knowledge
Description
Assessed using a built for purpose questionnaire, possible scores range from 0 to 8
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in prioritization of menstrual health
Description
Assessed using a built for purpose item, possible scores range from 0 to 4
Time Frame
Baseline and 4 weeks
Title
Change from baseline in confidence in endometriosis knowledge
Description
Assessed using a built for purpose item, possible scores range from 0 to 4
Time Frame
Baseline and 4 weeks
Title
Change from baseline in comfort with menstrual health
Description
Assessed using a built for purpose item, possible scores range from 0 to 4
Time Frame
Baseline and 4 weeks
Title
Acceptability of menstrual health and endometriosis education (quantitative)
Description
Assessed using a built for purpose questionnaire, possible scores range from 0 to 35
Time Frame
Immediately following education in intervention and waitlist control group
Title
Acceptability of menstrual health and endometriosis education (qualitative)
Description
Assessed using open-ended responses a built for purpose questionnaire
Time Frame
Immediately following education in intervention and waitlist control group
Title
Refusal of participants invited to participate
Description
Number of participants who refuse to participate divided by the number of participants invited to participate
Time Frame
Baseline
Title
Retention of participants
Description
Number of participants completing the study divided by the number of participants enrolled
Time Frame
4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
8-12 grade level class
Exclusion Criteria:
Instruction offered in a language other than English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Yong
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Women's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endocation: Trial of an Endometriosis Education Program
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