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Randomized Control Trial of a Virtual Patient Advocate for Preconception Care

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827215
First Posted: April 9, 2013
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Northeastern University
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Brian Jack, Boston Medical Center
  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: None (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 Brian Jack, Boston Medical Center:

Primary Outcome Measures:
  • Reduction in Number of Preconception Risks [ Time Frame: Baseline and at 12 months after enrollment ]
    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) ]
    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 ]
    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 ]
    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.


Enrollment: 531
Study Start Date: September 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes 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
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): NCT01827215


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Northeastern University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Brian W Jack, MD Boston University
  More Information

Responsible Party: Brian Jack, Professor and Chair, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01827215     History of Changes
Other Study ID Numbers: H-31633
R01MD006213 ( U.S. NIH Grant/Contract )
First Submitted: April 5, 2013
First Posted: April 9, 2013
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 Care
Racial Disparities
Health Information Technology