Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Intervention | Other | Animated video delivered by text message to prepare parents to communicate with physicians at their upcoming appointment for a fetal anomaly concern. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Administered 1 day after appointment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fetal Concerns Center Children's Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Maternal age at the time of consult appointment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Percentage of behavior items reported | Administered 1 day after appointment |
|
From enrollment until 72 hours after their fetal anomaly appointment, i.e., the time window in which the follow up assessment was completed.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
After five months of enrollment, an interim analysis was conducted by the principal investigator and study biostatisticians. Given the low likelihood of detecting a statistically significant difference with continued enrollment, the trial was stopped early for futility.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mir A Basir | Medical College of Wisconsin | (414) 266-6820 | mbasir@mcw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2024 | Mar 3, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D000013 | Congenital Abnormalities |
| D003142 | Communication |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Webpage links | Other | Links to publicly available webpages about the fetal concerns clinic where the participants' appointments are scheduled. |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Biological sex of participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | Self-reported maternal race | Participants could select more than one race that they identified. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Self-reported ethnicity | Count of Participants | Participants |
|
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.
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided
Not provided
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |