Study of Virtual Patient Advocate for Preconception Care for African American Women ("Gabby")
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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 |
- 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.
- 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: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (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 |
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| Contact: Brian W Jack, MD | 617-414-5956 | brian.jack@bmc.org |
| Contact: Megan B Hempstead, MPH | 617-414-6319 | megan.hempstead@bmc.org |
| United States, Massachusetts | |
| Boston Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Brian W Jack, MD 617-414-5956 brian.jack@bmc.org | |
| Contact: Megan B Hempstead, MPH 617-414-6319 megan.hempstead@bmc.org | |
| Principal Investigator: Jack W Jack, MD | |
| Sub-Investigator: Leanne Yinusa-Nyahkoon, ScD | |
| 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: | April 5, 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 May 21, 2013