Effectiveness of Web-based Teaching to Traditional Patient Education in the Use of Injectable Fertility Medications

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: Nurse instruction; Other: video instruction

Detailed Description

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:

1. A responsible clinician who has acquainted himself/herself with the research protocol will explain the study to each patient. Patients who agree to participate will sign a form documenting informed consent. The patient will then be handed an envelope that determines whether they will receive web-based teaching or one-on-one teaching.
2. The patients receiving web-based teaching will be taken to a private room to watch a video on injectable medication use. The amount of time required to view the video will be recorded. The video can be paused, rewound and watched as many times as the patient desires.
3. The patients randomized to one-on-one teaching will be taken to a separate room where they will be taught injectable medication use by one of two training healthcare providers with experience teaching injectable medications. The time spent in the teaching session will be recorded.
4. After the teaching session, each patient in the study will complete a multiple choice post-test regarding their knowledge of injectable medication use. They will also complete a satisfaction survey which will use a Likert scale to assess the patients' responses. The instructors teaching the one-on-one sessions will not have access to the post-test.

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center - Women's Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patient undergoing ART Therapy and ovulation induction via gonadotropins injection.

Exclusion Criteria:

• Any patient with prior history of IVF injectable use will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nurse instruction; Traditional injection teaching method. No video instruction	Other: Nurse instruction; Nurse directed instruction
Other: Video instruction; Video instruction that can be paused/repeated by subject	Other: video instruction; Patient Directed Video Instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tthe level of knowledge after the intervention measured by a multiple choice post-test	multiple choice post-test regarding their knowledge of injectable medication use	approximately 1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Satisfaction with education measured by the Likert scale survey	post intervention

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Michelle Matthews, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: April 13, 2015
• First Submitted That Met QC Criteria: April 17, 2015
• First Posted (Estimate): April 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: injectable; teaching methods
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 06-12-10E