- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01046188
Development of an Interactive Web-based Teaching Tool for in Vitro Fertilization (IVF) Patients (WebIVF)
January 14, 2010 updated by: Ottawa Fertility Centre
Development of an Interactive Web-based Teaching Tool for IVF Patients
The purpose of this study is to evaluate an interactive web-based teaching tool in IVF patients.
Patients will be randomized to participate in web-based IVF teaching or a didactic lecture.
A knowledge questionnaire will be completed both prior to and following the teaching intervention.
Both groups will also complete stress and satisfaction surveys throughout the IVF treatment cycle.
Groups will be compared at the completion of the study for demographics, level of knowledge, stress and satisfaction.
The web-based group will be evaluated for web usage.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
40
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
-
-
Ontario
-
Ottawa, Ontario, Canada, K2C 3V4
- Recruiting
- Ottawa fertility centre
-
Contact:
- Tannys DR Vause, MD
- Phone Number: 6136863378
- Email: tvause@conceive.ca
-
Contact:
- Mark Evans, MBA
- Phone Number: 6136863378
- Email: mevans@conceive.ca
-
Principal Investigator:
- Tannys DR Vause, MD
-
Sub-Investigator:
- Jason K Min, MD
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Subject >18 years of age
- Able to provide informed consent
- First cycle of IVF
- English speaking and reading
- Internet access at home or work (that is easily accessible for personal use)
Exclusion Criteria:
- Failure to complete a baseline knowledge questionnaire prior to IVF consent signing
- Previous attendance at an IVF teaching session
- Previous IVF treatment (at the Ottawa Fertility Centre or any other IVF clinic)
- Undergoing Natural Cycle IVF (these patients do not generally participate in teaching sessions, as they undergo one-on-one teaching)
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-based Teaching Group
Patients randomized to the intervention group will receive a unique login and password to a link on the Ottawa Fertility Centre website.
This will allow them access to a secure site containing required teaching modules.
They will then complete an interactive teaching tool that contains the same educational content as the traditional presentation.
Patients will be able to access a module that is specific to their stimulation protocol.
The teaching tool does not need to be completed all at one time.
Once completed, the information can still be accessed as many times as required.
|
Administered before and after teaching intervention
Administered before and after teaching intervention
Administered after the intervention and at study completion
Web-based IVF teaching
|
|
Active Comparator: Control group
Participants randomized to the control arm of the study will participate in a traditional didactic teaching session.
This session will be carried out by the nurse educator.
This session will be attended by up to 10 other couples that may or may not be participating in the study.
The nurse educator administering the session will not know which couples are participating in the study.
Slides shown and information conveyed will be the same as that provided to the web-based group, however all three stimulation protocols will be presented to the participants regardless of their actual treatment protocol.
|
Administered before and after teaching intervention
Administered before and after teaching intervention
Administered after the intervention and at study completion
Didactic lecture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess knowledge in IVF patients after completing either a web-based teaching module or traditional teaching session
Time Frame: Assessed prior to consenting to IVF treatment and after teaching intervention (within 6-8 weeks)
|
Assessed prior to consenting to IVF treatment and after teaching intervention (within 6-8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess stress levels in IVF patients after completing either a web-based teaching module or traditional teaching session
Time Frame: Assessed prior to consenting to IVF treatment and after teaching intervention (within 6-8 weeks)
|
Assessed prior to consenting to IVF treatment and after teaching intervention (within 6-8 weeks)
|
|
To assess satisfaction in IVF patients after completing either a web-based teaching module or traditional teaching session
Time Frame: Assessed after the teaching intervention and at study completion (within 4-6 weeks)
|
Assessed after the teaching intervention and at study completion (within 4-6 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tannys DR Vause, MD, Ottawa Fertility Centre, University of Ottawa
- Study Director: Jason K Min, MD, Ottawa Fertility Centre, University of Ottawa
- Study Director: Mark Evans, MBA, Ottawa Fertiilty Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Haagen EC, Tuil W, Hendriks J, de Bruijn RP, Braat DD, Kremer JA. Current Internet use and preferences of IVF and ICSI patients. Hum Reprod. 2003 Oct;18(10):2073-8. doi: 10.1093/humrep/deg423.
- Zebrack JR, Mitchell JL, Davids SL, Simpson DE. Web-based curriculum. A practical and effective strategy for teaching women's health. J Gen Intern Med. 2005 Jan;20(1):68-74. doi: 10.1111/j.1525-1497.2005.40062.x.
- Kerfoot BP, Brotschi E. Online spaced education to teach urology to medical students: a multi-institutional randomized trial. Am J Surg. 2009 Jan;197(1):89-95. doi: 10.1016/j.amjsurg.2007.10.026. Epub 2008 Jul 9.
- Ochoa JG, Wludyka P. Randomized comparison between traditional and traditional plus interactive Web-based methods for teaching seizure disorders. Teach Learn Med. 2008 Apr-Jun;20(2):114-7. doi: 10.1080/10401330801989513.
- Nilsson M, Bolinder G, Held C, Johansson BL, Fors U, Ostergren J. Evaluation of a web-based ECG-interpretation programme for undergraduate medical students. BMC Med Educ. 2008 Apr 23;8:25. doi: 10.1186/1472-6920-8-25.
- Spagnoletti CL, Sanders AM, McGee JB, Bost JE, McNeil MA. Teaching internal medicine residents to care for reproductive-age and pregnant women: an effective Web-based curriculum. Teach Learn Med. 2008 Apr-Jun;20(2):186-92. doi: 10.1080/10401330801991907.
- Huang JY, Al-Fozan H, Tan SL, Tulandi T. Internet use by patients seeking infertility treatment. Int J Gynaecol Obstet. 2003 Oct;83(1):75-6. doi: 10.1016/s0020-7292(03)00253-4. No abstract available.
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
January 1, 2010
Study Registration Dates
First Submitted
January 7, 2010
First Submitted That Met QC Criteria
January 8, 2010
First Posted (Estimate)
January 11, 2010
Study Record Updates
Last Update Posted (Estimate)
January 15, 2010
Last Update Submitted That Met QC Criteria
January 14, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OFC01
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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