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NCT06771453 · ClinicalTrials.gov registry record · NA
GEM: Impact of a Video Education Tool on Decisional Conflict Among Prenatal Patients
A NA study of Informed Consent and Aneuploidy, sponsored by Women and Infants Hospital of Rhode Island.
- Active
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT06771453: Active NA study of Informed Consent and Aneuploidy, sponsored by Women and Infants Hospital of Rhode Island.
NCT06771453 is a NA study of Informed Consent and Aneuploidy that is active but no longer recruiting, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 140 participants, below the 902-participant average among 9 other Informed Consent trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06771453, a NA study of Informed Consent and Aneuploidy, is active but no longer recruiting, sponsored by Women and Infants Hospital of Rhode Island.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this randomized clinical trial is to assess the impact of a video educational tool on patient decisional conflict at the time when making a decision about prenatal genetic testing. The control group will receive standard prenatal care. The secondary aims include assessing the impact of the video educational tool versus standard care on pregnant participants': perception of likelihood of having a baby affected by a genetic problem, intended plan for genetic testing, patient-provider communication, retention of prenatal genetics knowledge, and perception of genetic data privacy. Participants will be asked to: 1. Watch video education (if randomized to this group) and complete a baseline survey at their dating ultrasound regarding knowledge of prenatal genetics, prior experiences, and demographics 2. Complete a follow up survey after seeing their prenatal care provider regarding: decisional conflict scale with respect to prenatal genetic testing decision (primary outcome), perception of likelihood of having a baby affected by a genetic problem (secondary outcome) and the type of genetic testing chosen (secondary outcome). 3. Complete a second follow up survey six to ten weeks from the second survey to assess: Provider patient communication, retention of genetics knowledge, patient recollection of testing performed, and self-reported out of pocket cost related to genetic testing.
Primary Outcome
The investigators will assess the decisional conflict scale score around the time when patients make a decision about prenatal genetic screening options. The resulting score ranges from 0 to 100, with 0 indicating no decisional conflict (best outcome) and 100 indicating extremely high decisional conflict (worst outcome).
Conditions Studied
Interventions
- OTHER Video Educational Tool Regarding Prenatal Genetics
Study Locations (1)
Rhode Island
- Women and Infants - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2025-01-16 |
| Est. Completion | 2026-02 |
| Phase | NA |
What the registry record for NCT06771453 still lists
NCT06771453 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 902-participant average among 9 other Informed Consent trials with a reported enrollment target (84% lower).
The record links to 4 conditions, with Informed Consent appearing as the primary indexed condition, and to 1 intervention - of which Video Educational Tool Regarding Prenatal Genetics is the first listed.
NCT06771453 reports a single indexed study location in Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06771453 about?
NCT06771453 is a clinical study titled "GEM: Impact of a Video Education Tool on Decisional Conflict Among Prenatal Patients". The goal of this randomized clinical trial is to assess the impact of a video educational tool on patient decisional conflict at the time when making a decision about prenatal genetic testing. The control group will receive standard prenatal care. The secondary aims include assessing the impact of ...
What is the current status of trial NCT06771453?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2025-01-16. Estimated completion is 2026-02.
What conditions does trial NCT06771453 study?
This clinical trial studies the following conditions: Informed Consent, Aneuploidy, Genetic Counseling, Decisional Conflict.
What interventions are being tested in trial NCT06771453?
The interventions under investigation include: Video Educational Tool Regarding Prenatal Genetics (OTHER).
Who is sponsoring clinical trial NCT06771453?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06771453 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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