Patient EmpowermentNCT06323343
Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits
A study testing Video Intervention and Webpage links in people with Patient Empowerment, run by Medical College of Wisconsin at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patient Empowerment
- What is being tested?
- Video Intervention and Webpage links
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2024to 31 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fetal Concerns Center Children's Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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.
- Conditions
- Patient Empowerment
- Being tested
- Video Intervention, Webpage links
- Keywords
- Prenatal care, Congenital abnormalities, Communication, Mobile health
- Medical subject headings
- Patient Participation, Congenital Abnormalities, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video InterventionOther
Animated video delivered by text message to prepare parents to communicate with physicians at their upcoming appointment for a fetal anomaly concern.
Webpage linksOther
Links to publicly available webpages about the fetal concerns clinic where the participants' appointments are scheduled.
| Study group | Role | What they receive |
|---|---|---|
| Video Intervention | Experimental | 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. Receives: Other: Video Intervention |
| Webpage links | Active comparator | 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. Receives: Other: Webpage links |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' Communication Behaviors Measure
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.
Measured: Administered 1 day after appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start15 Jun 2024
- Primary completion11 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patient EmpowermentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mir A Basir, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323343
- Sponsor's protocol ID
- 00040976
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2024
- Last updated
- 24 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No