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

NCT ID: NCT02420964

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-04-30

Brief Summary

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.

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nurse instruction

Traditional injection teaching method. No video instruction

Group Type: OTHER

Nurse instruction

Intervention Type: OTHER

Nurse directed instruction

Video instruction

Video instruction that can be paused/repeated by subject

Group Type: OTHER

video instruction

Intervention Type: OTHER

Patient Directed Video Instruction

Interventions

video instruction

Patient Directed Video Instruction

Intervention Type: OTHER

Nurse instruction

Nurse directed instruction

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Matthews, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Carolinas Medical Center - Women's Institute

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

06-12-10E

Identifier Type: -

Identifier Source: org_study_id