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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Northeastern University
Information provided by (Responsible Party):
Brian Jack, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01812824
First received: March 14, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention
Preconception Care
Behavioral: Intervention (Virtual Patient Advocate)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Using Innovative Communication Technology to Improve the Health of Young African American Women

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Reduction in number of Preconception Health Risks [ Time Frame: Baseline and at 6 months after enrollment ] [ Designated as safety issue: No ]
    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:
  • Pregnancy Rate [ Time Frame: Assessed 6 months after enrollment ] [ Designated as safety issue: No ]
    During the outcome phone call the investigators will assess whether or not the participant has become pregnant during the study period.

  • Subject Satisfaction with Virtual Patient Advocate [ Time Frame: Assessed at 6 months after enrollment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 230
Study Start Date: February 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812824

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

Publications:
Responsible Party: Brian Jack, Professor and Chair, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01812824     History of Changes
Other Study ID Numbers: R40MC21510
Study First Received: March 14, 2013
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on July 29, 2014