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Study of Virtual Patient Advocate for Preconception Care for African American Women ("Gabby")

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ClinicalTrials.gov Identifier: NCT01812824
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study is to examine the effectiveness of a health communication system (Gabby) that assesses preconception health risks and tailors the intervention to each subject, based on her health risks.

There is a need to develop practical tools that can be used to identify preconception health risks and will facilitate the initiation of intervention for these 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 over 100 preconception health risks that can impact birth outcomes; this 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.

This study involves a pilot of the system through the Preconception Peer Educator (PPE) Program, which is a program created by the Office of Minority Health. The program began in historically black colleges in the United States, with the purpose of training students to reach out to their community to educate about the increased risk of preterm birth, low birth weight and infant mortality among African Americans. The PPEs teach about preconception health, or getting healthy before pregnancy, to increase the chances of having a healthy baby. Now the PPE program has expanded to colleges in over 20 states across the country.

Condition or disease Intervention/treatment
Preconception Care Behavioral: Intervention (Virtual Patient Advocate)

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Innovative Communication Technology to Improve the Health of Young African American Women
Study Start Date : February 2011
Primary Completion Date : February 2014
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention (Virtual Patient Advocate)
Participants assigned to the Intervention (Virtual Patient Advocate) arm will have access to the Virtual Patient Advocate system on-line for 6 months; they will be encouraged, but not required, to log on once a week.
Behavioral: Intervention (Virtual Patient Advocate)
Intervention (Virtual Patient Advocate) participants will have access to the "Gabby" system for 6 months. There is no required "dose" or frequency that they have to log on to the system, but the investigators will suggest that they log on once a week.
No Intervention: Control (Letter)
Participants in the Control (Letter) arm will take the online Preconception Risk Assessment at baseline, but not have access to the Virtual Patient Advocate system during the 6 month study period. They will be sent a list of the Preconception Risks identified through their answers to the Risk Assessment, which they can choose to share with their healthcare provider(s).

Outcome Measures

Primary Outcome Measures :
  1. Reduction in number of Preconception Health Risks [ Time Frame: Baseline and at 6 months after enrollment ]
    Number of preconception risks will be tallied for each participant at baseline and 6 months after enrollment. Participants will complete the Preconception Risk assessment at both time points.

Secondary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: Assessed 6 months after enrollment ]
    During the outcome phone call the investigators will assess whether or not the participant has become pregnant during the study period.

  2. Subject Satisfaction with Virtual Patient Advocate [ Time Frame: Assessed at 6 months after enrollment ]
    During the follow-up phone call, the investigators will ask all intervention participants a series of satisfaction questions about various features of the Virtual Patient Advocate system.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • female
  • African American
  • ages 18-25
  • access to telephone and agrees to receive study-related calls
  • access to computer with high-speed internet

Exclusion Criteria:

  • Does not speak English
  • Is currently pregnant
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812824

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Northeastern University
Principal Investigator: Brian W Jack, MD Boston University
More Information

Responsible Party: Brian Jack, Professor and Chair, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01812824     History of Changes
Other Study ID Numbers: H-31014
R40MC21510 ( Other Grant/Funding Number: HRSA )
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian Jack, Boston Medical Center:
Preconception Health
Health Information Technology
Reproductive Life Plan
Healthcare Disparities
Low birth-weight
Preterm Delivery