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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: Completed NA study, sponsored by Boston Medical Center.
NCT01827215 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 528 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Our 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.
Interventions
- BEHAVIORAL Virtual Patient Advocate (VPA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 528 participants |
| Start Date | 2013-09 |
| Est. Completion | 2019-01 |
| Phase | NA |
What the finished NCT01827215 record still lists
NCT01827215 is an interventional study that assigns participants to a tested intervention. The registered 528 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which Virtual Patient Advocate (VPA) is the first listed.
NCT01827215 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01827215's enrollment target sits among peer trials
528 188th of 2000 higher than 1,812 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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