The Use of an Online Learning and Consent Platform in Infertility Treatment

NCT03962257 | Completed

• 1 other identifier: 18-3258
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The primary purpose of this study is to objectively assess if interactive multimedia tutorials (online videos) enhances patients' comprehensive understanding of assisted reproductive technology (ART) adding EngagedMD, an online library of interactive videos, compared to the traditional process of consent and one-on-one teaching using a 15 question evaluation. The secondary outcome will be to qualitatively assess patients' overall experience of the teaching process comparing the addition of the EngagedMD content to solely traditional teaching for infertility treatment.

Conditions

Patient Satisfaction

Keywords

Patient education

Outcome Measures

Primary Outcomes (1)

• Patient understanding

  Patient understanding of infertility diagnoses and treatment by use of a pre and post test. The test comprises of 15 multiple choice questions and the patients will receive a score of 0-15 and this will be compared as a paired continuous variable from the pre-test score to their post-test score as well as an un-paired continuous variable between the conventional group and the EngagedMD group for pre- and post-test scores as well as delta scores between the two.

  Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.

Secondary Outcomes (1)

• Patient satisfaction

  Each participant will be followed for one treatment cycle, or approximately 2-4 weeks.

Study Arms (2)

Conventional

NO INTERVENTION

This group will have standard of care infertility counseling and consent processes.

Engaged MD

EXPERIMENTAL

This group will have standard of care infertility counseling and access to online teaching modules and the ability to sign consents online.

Other: EngagedMD online learning platform

Interventions

EngagedMD online learning platform OTHER

The EngagedMD online learning platform is a compilation of learning modules and questions designed to give patients at-home access to visual and audio aids in infertility treatment. It also gives patients the ability to read and sign consents from home.

Engaged MD

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects must be 18-49 years of age undergoing fertility treatment
• Able to give Informed Consent

You may not qualify if:

• Patients who do not have adequate command of the English language to provide informed consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (3)

Fertility CARE: The IVF Center

Winter Park, Florida, 32792, United States

Location

Positive Steps Fertility

Madison, Mississippi, 39110, United States

Location

UNC Fertility

Raleigh, North Carolina, 27616, United States

Location

Related Publications (1)

• Bernard AL, Barbour AK, Meernik C, Madeira JL, Lindheim SR, Goodman LR. The impact of an interactive multimedia educational platform on patient comprehension and anxiety during fertility treatment: a randomized controlled trial. F S Rep. 2022 May 22;3(3):214-222. doi: 10.1016/j.xfre.2022.05.006. eCollection 2022 Sep.

  PMID: 36212557 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Linnea R Goodman, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial comparing one group receiving standard care and the other with standard care with the addition of the online learning platform

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 24, 2019
• Study Start: March 30, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)