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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06323343
Other study ID # 00040976
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 28, 2024
Est. completion date January 31, 2025

Study information

Verified date March 2024
Source Medical College of Wisconsin
Contact Mir A Basir, MD
Phone 414-266-6820
Email mbasir@mcw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to test an animated video delivered by text message in patients whose pregnancies are complicated with fetal anomalies. The main question it aims to answer is: Does the video intervention prepare parents to talk to the doctors during prenatal appointments? Participants will be randomized to receive either the video intervention or links to the clinic's webpages. They will complete an enrollment survey before their appointment and a follow up survey after their appointment. The researchers will compare the video and webpage groups to see which group reports engaging in more of the identified best-practices of communication.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 114
Est. completion date January 31, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant patient scheduled for an appointment at the Children's Wisconsin Fetal Concerns Center for a fetal anomaly. - Able to speak and understand English (intervention videos are only currently available in English). - Age of 18 years or older. Exclusion Criteria: - Pregnant patient's appointment at Children's Wisconsin Fetal Concerns center is not for a fetal anomaly (e.g., screening only, past pregnancy with anomaly only cause of appointment) - Pregnant patient is considering termination of pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Video Intervention
Animated video delivered by text message to prepare parents to communicate with physicians at their upcoming appointment for a fetal anomaly concern.
Webpage links
Links to publicly available webpages about the fetal concerns clinic where the participants' appointments are scheduled.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical College of Wisconsin

Outcome

Type Measure Description Time frame Safety issue
Primary Parents' communication behaviors measure Participants' self-reported behaviors during the prenatal fetal anomaly appointment, on a scale from 0-14, with higher scores indicating a higher rate of best-practice communication behaviors. Administered 1 day after appointment
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