- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06323343
Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Fetal Concerns Center Children's Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video Intervention
Participants assigned to the video intervention group receive a text message prior to their prenatal fetal anomaly appointment.
Embedded in that text message is a link to an animated video which provides education on best practices of communicating with providers.
|
Animated video delivered by text message to prepare parents to communicate with physicians at their upcoming appointment for a fetal anomaly concern.
|
|
Active Comparator: Webpage links
Participants assigned to the webpage links group receive links to the clinic's publicly available webpages prior to their prenatal fetal anomaly appointment.
The webpages provide background about the providers and services available as well as a tour of the clinic.
|
Links to publicly available webpages about the fetal concerns clinic where the participants' appointments are scheduled.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parents' Communication Behaviors Measure
Time Frame: Administered 1 day after appointment
|
Participants' self-reported behaviors during the prenatal fetal anomaly appointment; of the 13 behavioral items, scored as percentage of behaviors reported, with higher scores indicating a higher rate of best-practice communication behaviors.
|
Administered 1 day after appointment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00040976
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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