NCT02420964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

April 13, 2015

Last Update Submit

April 19, 2022

Conditions

Keywords

injectableteaching methods

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Satisfaction with education measured by the Likert scale survey

    post intervention

Study Arms (2)

Nurse instruction

OTHER

Traditional injection teaching method. No video instruction

Other: Nurse instruction

Video instruction

OTHER

Video instruction that can be paused/repeated by subject

Other: video instruction

Interventions

Patient Directed Video Instruction

Video instruction

Nurse directed instruction

Nurse instruction

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center - Women's Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Michelle Matthews, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 20, 2015

Study Start

June 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2015

Last Updated

April 25, 2022

Record last verified: 2015-04

Locations