Carolinas Medical Center - Women's Institute
Charlotte, North Carolina, 28204, United States
NCT Number: NCT02420964
The study will be a prospective randomized trial involving human subjects. The study population will consist of all infertility patients presenting to the Carolinas Medical Center Women's Institute who will require injectable use.
Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded from the study.
Independent Variables: The independent variable is the random assignment of each participant to receive either web-based or one on one teaching.
Outcome Variables: The primary outcome variable is the level of knowledge after the intervention. Secondary outcome variables include level of satisfaction with education, preference of educational method, and time required to teach.
Confounding Variables: Potentially confounding variables include age, race, and prior experience with web-based teaching.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Charlotte, North Carolina, 28204, United States
Study Design:
The study will be a prospective randomized trial involving human subjects. The study population will consist of all infertility patients presenting to the Carolinas Medical Center Women's Institute who will require injectable use.
Exclusion criteria
Any patient with prior history of IVF injectable use will be excluded from the study.
Independent Variables: The independent variable is the random assignment of each participant to receive either web-based or one on one teaching.
Outcome Variables: The primary outcome variable is the level of knowledge after the intervention. Secondary outcome variables include level of satisfaction with education, preference of educational method, and time required to teach.
Confounding Variables: Potentially confounding variables include age, race, and prior experience with web-based teaching.
Methods:
Statistics:
The categorical variables will be summarized with frequencies and percentages while the continuous variables will be evaluated with means and standard deviations. A difference in proportion will be tested based on the data collected between the web-based group and didactic group. Non-inferiority testing will be conducted based on these differences with a 5% significance level. Data analysis will be conducted using SAS statistical software (9.2,Cary,NC,USA) .
Sample Size Estimate:
To predict that the web-based testing group is not inferior to the Didactic testing group about 40 people in each group would be needed to achieve 80% power with a 5% significance level. The sample size needed was calculated using the Z-test. Here it is assumed that the didactic group would get 80% of their answers correct and the web-based group would actually have 90% of their answers correct.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient Directed Video Instruction
Nurse directed instruction
Time frame: approximately 1 hour
multiple choice post-test regarding their knowledge of injectable medication use
Time frame: post intervention
Wake Forest University Health Sciences
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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