Randomized Control Trial of a Virtual Patient Advocate for Preconception Care
|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.|
|ClinicalTrials.gov Identifier: NCT01827215|
Recruitment Status : Active, not recruiting
First Posted : April 9, 2013
Last Update Posted : March 7, 2018
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 or disease||Intervention/treatment||Phase|
|Preconception Care||Behavioral: Intervention (VPA)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||531 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using Innovative Communication Technology to Improve the Health of Young African American Women|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
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.
- 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.
- 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.
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
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Brian W Jack, MD||Boston University|