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

NCT ID: NCT03962257

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-30

Study Completion Date

2020-12-10

Brief Summary

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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.

Detailed Description

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Participants: This will be a multi-center trial with each center planning on recruiting 100 couples. Half of the couples will be planning on undergoing ovulation induction with insemination (OI/IUI) and the other half in-vitro fertilization (IVF).

Procedures (methods): This is a multi-center prospective randomized controlled trial where couples undergoing OI/IUI or IVF will be randomized to receiving the current traditional standard of in-person treatment teaching by their physician and nursing team with standard paper consents or to the identical process of in-person teaching with the addition of unrestricted access to the EngagedMD online video resource platform with online consents.

Patient demographics, knowledge base, psychological impact of with the treatment, teaching and the consent process and overall satisfaction with the process as a whole will be assessed using surveys administered at three time points throughout the treatment process. A subset of patients that agree will be contacted after the completion of the treatment cycle for a live phone interview.

Conditions

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Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial comparing one group receiving standard care and the other with standard care with the addition of the online learning platform
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Conventional

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Engaged MD

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

Group Type EXPERIMENTAL

EngagedMD online learning platform

Intervention Type 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.

Interventions

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EngagedMD online learning platform

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients who do not have adequate command of the English language to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linnea R Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Fertility CARE: The IVF Center

Winter Park, Florida, United States

Site Status

Positive Steps Fertility

Madison, Mississippi, United States

Site Status

UNC Fertility

Raleigh, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36212557 (View on PubMed)

Other Identifiers

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18-3258

Identifier Type: -

Identifier Source: org_study_id

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