Patient Empowerment
Conditions
Keywords
Prenatal care, Congenital abnormalities, Communication, Mobile health
Brief 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.
Interventions
OTHERVideo Intervention
Animated video delivered by text message to prepare parents to communicate with physicians at their upcoming appointment for a fetal anomaly concern.
OTHERWebpage links
Links to publicly available webpages about the fetal concerns clinic where the participants' appointments are scheduled.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parents' Communication Behaviors Measure | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 20-24 years | 7 Participants |
| Age, Customized 25-29 years | 13 Participants |
| Age, Customized 30-34 years | 14 Participants |
| Age, Customized 35 years or greater | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
None listed