Randomized Control Trial of a Virtual Patient Advocate for Preconception Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Boston Medical Center
Sponsor:
Collaborator:
Northeastern University
Information provided by (Responsible Party):
Brian Jack, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01827215
First received: April 5, 2013
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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 18-25. 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.


Condition Intervention
Preconception Care
Behavioral: Intervention (VPA)

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 Risks [ Time Frame: Baseline and at 12 months after enrollment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Dose of Exposure to Virtual Patient Advocate (VPA) System [ Time Frame: 12 months after enrollement (data gathered by online system throughout the 12 month intervention period) ] [ Designated as safety issue: No ]
    Frequency of exposure (in other words, number of log-ins) to the VPA system over the course of 12 months. Duration of log-ins will also be considered (average duration of log-in, minimum and maximum duration observed, etc).

  • Subject Satisfaction with Virtual Patient Advocate (VPA) system [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    We will administer a satisfaction survey to all intervention participants to measure their level of satisfaction with the system overall, with the VPA character, and also with specific features of the system.

  • Healthcare Provider Satisfaction [ Time Frame: Following the participant's appointment with a primary care provider, at any point during the 12 month intervention period ] [ Designated as safety issue: No ]
    We will conduct qualitative interviews with the health care providers of intervention participants, to gather feedback about how the interaction with the VPA did or did not affect the patient-provider interaction.


Estimated Enrollment: 530
Study Start Date: September 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention (Virtual Patient Advocate)
The Intervention Group. Intervention participants from the RCT will be given a username and secure password to log on to the Gabby site for the 12 months of the intervention. They will be encouraged to log on at least monthly, but using the system is voluntary. They will be given the contact information of the Program Manager in the event that they have any issues or questions about the system. The research team will call each intervention participant after 12 months to conduct a follow-up phone call to collect outcome data. At that point, intervention participants will be invited to participate a focus group session.
Behavioral: Intervention (VPA)
Intervention participants will have access to the Virtual Patient Advocate system for a period of 12 months. They will be encouraged to log on at least once a month, but frequency and duration of conversations with the VPA is at the discretion of the participant.
No Intervention: Control (Letter)
The control group will receive a letter listing the preconception risks identified in the risk assessment and they will be encouraged to see their clinician to discuss them.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Do not speak English
  • Self-reported pregnant at the time of enrollment
  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: NCT01827215

Contacts
Contact: Brian W Jack, MD 617-414-5956 brian.jack@bmc.org
Contact: Megan B Hempstead 6174146319 megan.hempstead@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Megan B Hempstead, MPH    617-414-6319    megan.hempstead@bmc.org   
Contact: Jessica M Martin, MA, MPH    617-414-6565    jessica.martin@bmc.org   
Principal Investigator: Brian W Jack, MD         
Sponsors and Collaborators
Boston Medical Center
Northeastern University
Investigators
Principal Investigator: Brian W Jack, MD Boston University
  More Information

No publications provided

Responsible Party: Brian Jack, Professor and Chair, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01827215     History of Changes
Other Study ID Numbers: R01MD006213
Study First Received: April 5, 2013
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Preconception Care
Racial Disparities
Health Information Technology

ClinicalTrials.gov processed this record on October 29, 2014