Randomized Control Trial of a Virtual Patient Advocate for Preconception Care
Completed · Not applicable
Conditions studied: Preconception Care
In brief
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.
Key facts
- Study ID
- NCT01827215
- Run by
- Boston Medical Center
- People needed
- 528
- Starts
- 2013-09-01
- Expected to finish
- 2019-01-01
- Last updated by the study team
- 2019-10-03
Who can join
Age: 18 and older, up to 34. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female
- Between the ages of 18-34
- Self-identify as Black or African American
- Have a phone and are willing to receive study-related phone calls
- Have access to a computer with internet
You may not qualify if…
- Do not speak English
- Self-reported pregnant at the time of enrollment
Where it is running
- Boston Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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