EducationWebIVFNCT01046188
Development of an Interactive Web-based Teaching Tool for in Vitro Fertilization (IVF) Patients
A study testing Knowledge Questionnaire, Perceived Stress Scale and Satisfaction questionnaire in people with Education, run by Ottawa Fertility Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Education
- What is being tested?
- Knowledge Questionnaire, Perceived Stress Scale and Satisfaction questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Ottawa Fertility Centre
Ottawa, Ontario, K2C 3V4
Tannys DR Vause, MD, 6136863378, tvause@conceive.ca
Mark Evans, MBA, 6136863378, mevans@conceive.ca
About this study
Official title: 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.
- Conditions
- Education
- Being tested
- Knowledge Questionnaire, Perceived Stress Scale, Satisfaction questionnaire, Web-based IVF teaching, Didactic lecture
- Keywords
- Education, Internet, In vitro fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge QuestionnaireOther
Administered before and after teaching intervention
Perceived Stress ScaleOther
Administered before and after teaching intervention
Satisfaction questionnaireOther
Administered after the intervention and at study completion
Web-based IVF teachingOther
Web-based IVF teaching
Didactic lectureOther
Didactic lecture
| Study group | Role | What they receive |
|---|---|---|
| Web-based Teaching Group | Experimental | 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. Receives: Other: Knowledge Questionnaire; Other: Perceived Stress Scale; Other: Satisfaction questionnaire; Other: Web-based IVF teaching |
| Control group | Active comparator | 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. Receives: Other: Knowledge Questionnaire; Other: Perceived Stress Scale; Other: Satisfaction questionnaire; Other: Didactic lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess knowledge in IVF patients after completing either a web-based teaching module or traditional teaching session
Measured: Assessed prior to consenting to IVF treatment and after teaching intervention (within 6-8 weeks)
Secondary outcomes (2)
To assess stress levels in IVF patients after completing either a web-based teaching module or traditional teaching session
Measured: 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
Measured: Assessed after the teaching intervention and at study completion (within 4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Fertility Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- Tannys DR Vause, MD, Principal investigator, Ottawa Fertility Centre, University of OttawaJason K Min, MD, Study director, Ottawa Fertility Centre, University of OttawaMark Evans, MBA, Study director, Ottawa Fertiilty Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046188
- Sponsor's protocol ID
- OFC01
- Acronym
- WebIVF
- Status last verified
- Jan 2010
- First submitted
- 7 Jan 2010
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 14507823Zebrack 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.
PubMed 15693931Kerfoot 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.
PubMed 18614145Ochoa 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.
PubMed 18444196Nilsson 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.
PubMed 18430256Spagnoletti 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.
PubMed 18444208Huang 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.
PubMed 14511879
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Interactive Web-based Teaching Tool for IVF Patients
- ClinicalTrials.gov ID
- NCT01046188
- Acronym / sponsor ID
- WebIVF / OFC01
- Conditions
- Education
- Keywords
- Education, Internet, In vitro fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ottawa Fertility CentreUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Jan 2010
- First posted
- 11 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based Teaching Group | Experimental | Other: Knowledge Questionnaire, Other: Perceived Stress Scale, Other: Satisfaction questionnaire, Other: Web-based IVF teachingPatients 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. |
| Control group | Active comparator | Other: Knowledge Questionnaire, Other: Perceived Stress Scale, Other: Satisfaction questionnaire, Other: Didactic lectureParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge QuestionnaireAdministered before and after teaching intervention | Other | Control group, Web-based Teaching Group |
| Perceived Stress ScaleAdministered before and after teaching intervention | Other | Control group, Web-based Teaching Group |
| Satisfaction questionnaireAdministered after the intervention and at study completion | Other | Control group, Web-based Teaching Group |
| Web-based IVF teachingWeb-based IVF teaching | Other | Web-based Teaching Group |
| Didactic lectureDidactic lecture | Other | Control group |
Primary outcome
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)
2 secondary outcomes
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2010.
- Background: PubMed 14507823Haagen 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.
- Background: PubMed 15693931Zebrack 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.
- Background: PubMed 18614145Kerfoot 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.
- Background: PubMed 18444196Ochoa 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.
- Background: PubMed 18430256Nilsson 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.
- Background: PubMed 18444208Spagnoletti 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.
- Background: PubMed 14511879Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tannys DR Vause, MD principal investigator
Ottawa Fertility Centre, University of Ottawa
Jason K Min, MD study director
Ottawa Fertility Centre, University of Ottawa
Mark Evans, MBA study director
Ottawa Fertiilty Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge Questionnaire, Perceived Stress Scale and Satisfaction questionnaire in people with Education, run by Ottawa Fertility Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tannys DR Vause, MD (6136863378, tvause@conceive.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01046188, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2010.