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NCT01827215 · ClinicalTrials.gov registry record · NA
Randomized Control Trial of a Virtual Patient Advocate for Preconception Care
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 528
- Enrollment target
NCT01827215 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 528 participants.
The verdict
NCT01827215, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 528 participants
- Enrollment target
Study Summary
This study is to examine the effectiveness of a health communication system (Gabby) that assesses preconception health risks and tailors the education and intervention to each subject, based on her health risks. This project specifically targets young Black or African American women in order to reduce major disparities in birth outcomes. Clinicians do not have time to assess for the over 100 preconception health risks that can impact birth outcomes; the investigators system can streamline that assessment and create a personalized list of risks. Patients can then share their list with clinicians to make their healthcare visits more effective. The investigators will conduct a two-armed randomized controlled trial (RCT) designed to enroll 530 African American women ages 18-34. After all subjects complete a comprehensive preconception health risk assessment, the intervention group will be trained to use the Gabby system and encouraged to use it at least monthly for one year. The control group will receive a letter listing the risks identified and they will be encouraged to see their clinician to discuss them. The investigators primary hypothesis will test whether the Gabby system will result in a lower rate of preconception health risks, as defined by CDC, as compared to the control group after 12 months. Secondary outcomes include: measurement of usage rates, dose of exposure, attrition, subject and healthcare provider satisfaction, and number of women with a personalized health plan.
Interventions
- BEHAVIORAL Virtual Patient Advocate (VPA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 528 participants |
| Start Date | 2013-09 |
| Est. Completion | 2019-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01827215
The ClinicalTrials.gov registry entry for NCT01827215 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 528 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Virtual Patient Advocate (VPA) is the first listed.
NCT01827215 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01827215 about?
NCT01827215 is a clinical study titled "Randomized Control Trial of a Virtual Patient Advocate for Preconception Care". This study is to examine the effectiveness of a health communication system (Gabby) that assesses preconception health risks and tailors the education and intervention to each subject, based on her health risks. This project specifically targets young Black or African American women in order to redu...
What is the current status of trial NCT01827215?
This trial is currently completed. It is a NA study. The enrollment target is 528 participants. The study started on 2013-09. Estimated completion is 2019-01.
What interventions are being tested in trial NCT01827215?
The interventions under investigation include: Virtual Patient Advocate (VPA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01827215?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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