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NCT04514224 · ClinicalTrials.gov registry record
Gabby Implementation: Parent Protocol
A clinical trial, sponsored by Boston Medical Center.
- Completed
- Registry status
- 125
- Enrollment target
NCT04514224: Completed study, sponsored by Boston Medical Center.
NCT04514224 is a clinical trial that has completed, run by Boston Medical Center. The registered enrollment target is 125 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04514224 has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- 125 participants
- Enrollment target
Study Summary
The Gabby Preconception Care program is an innovative communication system designed to identify and mitigate or resolve health risks for young Black and African American (AA) women before pregnancy, as a means of reducing racial health disparities in birth outcomes. The system uses embodied conversational agent technology the investigators call "Gabby," who empathically interacts with users to assess health risks and delivers interventions to resolve or mitigate these risks. This research team has been working on the "Gabby" Preconception Care program, which features Virtual Patient Advocate (VPA) technology, for over seven years and the system is now ready for dissemination beyond the research environment and into the clinical and community context. The purpose of this project is to examine the implementation and dissemination process of the evidence-based Gabby Program. Caseworkers at Healthy Start (HS) Programs and healthcare providers at Community Health Centers (CHC's) do not have time to assess for the over 100 preconception health risks that can impact birth outcomes; our system can assist by streamlining that assessment to create a personalized list of risks.Gabby will be introduced/released to sites as part of their standard of care where patients and clients can then share their list with healthcare providers and case workers/managers to make their in-person interactions much more effective. Studies by the research team have shown that Gabby reduces health risks by 25 percent among young Black and AA women. The investigators will evaluate the success of the implementation process through both quantitative and qualitative measures including key informant telephone interviews and guidance from a Gabby Toolkit Advisory Board in order to prepare an implementation toolkit that can be used to facilitate broader dissemination. The Gabby program will not be evaluated as a research intervention, as this has been done previously, instead, how well the Gabby program
Primary Outcome
Information about the acceptability of the Gabby system will be gleaned form qualitative and quantitative data. Virtual interviewers of key staff will be done informed by an interview guide to collect the qualitative data. The quantitative data will be assessed using an investigator developed 33-question Likert scale-based survey. Responses along the 5-point Likert scale will consist of Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), Strongly Agree (5). Higher score from acceptabili
Interventions
- OTHER Gabby implementation
- OTHER Evaluate the Gabby implementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2017-10-15 |
| Est. Completion | 2022-03-15 |
What the finished NCT04514224 record still lists
NCT04514224 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Gabby implementation is the first listed.
NCT04514224 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04514224 about?
NCT04514224 is a clinical study titled "Gabby Implementation: Parent Protocol". The Gabby Preconception Care program is an innovative communication system designed to identify and mitigate or resolve health risks for young Black and African American (AA) women before pregnancy, as a means of reducing racial health disparities in birth outcomes. The system uses embodied conversa...
What is the current status of trial NCT04514224?
This trial is currently completed. The enrollment target is 125 participants. The study started on 2017-10-15. Estimated completion is 2022-03-15.
What interventions are being tested in trial NCT04514224?
The interventions under investigation include: Gabby implementation (OTHER), Evaluate the Gabby implementation (OTHER).
Who is sponsoring clinical trial NCT04514224?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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