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Randomized Control Trial of a Virtual Patient Advocate for Preconception Care

NCT01827215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2019-10-03

No results posted yet for this 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.

Conditions

  • Preconception Care

Interventions

BEHAVIORAL

Virtual Patient Advocate (VPA)

Intervention participants will have access to the Virtual Patient Advocate (VPA) system for a period of 12 months. They will be encouraged to log on every two weeks or twice a month, but frequency and duration of conversations with the VPA is at the discretion of the participant.

Sponsors & Collaborators

  • Northeastern University

    collaborator OTHER

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Brian W Jack, MD · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-04-30
Completion
2019-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01827215 on ClinicalTrials.gov