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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
video instruction
Nurse instruction
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility focused on measuring injectable, teaching methods

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Carolinas Medical Center - Women's Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Nurse instruction

Video instruction

Arm Description

Traditional injection teaching method. No video instruction

Video instruction that can be paused/repeated by subject

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Satisfaction with education measured by the Likert scale survey

Full Information

First Posted
April 13, 2015
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02420964
Brief Title
Effectiveness of Web-based Teaching to Traditional Patient Education in the Use of Injectable Fertility Medications
Official Title
Effectiveness of Web-based Teaching to Traditional Patient Education in the Use of Injectable Fertility Medications
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
injectable, teaching methods

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nurse instruction
Arm Type
Other
Arm Description
Traditional injection teaching method. No video instruction
Arm Title
Video instruction
Arm Type
Other
Arm Description
Video instruction that can be paused/repeated by subject
Intervention Type
Other
Intervention Name(s)
video instruction
Intervention Description
Patient Directed Video Instruction
Intervention Type
Other
Intervention Name(s)
Nurse instruction
Intervention Description
Nurse directed instruction
Primary Outcome Measure Information:
Title
Tthe level of knowledge after the intervention measured by a multiple choice post-test
Description
multiple choice post-test regarding their knowledge of injectable medication use
Time Frame
approximately 1 hour
Secondary Outcome Measure Information:
Title
Satisfaction with education measured by the Likert scale survey
Time Frame
post intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Matthews, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center - Women's Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States

12. IPD Sharing Statement

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

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