Preconception Care Clinical Trial
Official title:
Using Innovative Communication Technology to Improve the Health of Young African American Women
Verified date | October 2019 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 18-34. 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.
Status | Completed |
Enrollment | 528 |
Est. completion date | January 2019 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 34 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | National Institute on Minority Health and Health Disparities (NIMHD), Northeastern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in Number of Preconception Risks | 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. | Baseline and at 12 months after enrollment | |
Secondary | Dose of Exposure to Virtual Patient Advocate (VPA) System | 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). | 12 months after enrollement (data gathered by online system throughout the 12 month intervention period) | |
Secondary | Subject Satisfaction with Virtual Patient Advocate (VPA) system | 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. | 12 months after enrollment | |
Secondary | Healthcare Provider Satisfaction | 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. | Following the participant's appointment with a primary care provider, at any point during the 12 month intervention period |
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