Study of Virtual Patient Advocate for Preconception Care for African American Women

NCT01812824 | Completed

• 2 other identifiers: H-31014R40MC21510
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preconception Care

Keywords

Preconception Health; Health Information Technology; Reproductive Life Plan; Healthcare Disparities; Low birth-weight; Preterm Delivery

Outcome Measures

Primary Outcomes (1)

• Reduction in number of Preconception Health Risks

  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.

  Baseline and at 6 months after enrollment

Secondary Outcomes (2)

• Pregnancy Rate

  Assessed 6 months after enrollment

• Subject Satisfaction with Virtual Patient Advocate

  Assessed at 6 months after enrollment

Study Arms (2)

Intervention (Virtual Patient Advocate)

EXPERIMENTAL

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)

Control (Letter)

NO INTERVENTION

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).

Interventions

Intervention (Virtual Patient Advocate) BEHAVIORAL

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.

Intervention (Virtual Patient Advocate)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female
• African American
• ages 18-25
• access to telephone and agrees to receive study-related calls
• access to computer with high-speed internet

You may not qualify if:

• Does not speak English
• Is currently pregnant

Sponsors & Collaborators

• Boston Medical Center: lead
• Northeastern University: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• Gardiner P, Hempstead MB, Ring L, Bickmore T, Yinusa-Nyahkoon L, Tran H, Paasche-Orlow M, Damus K, Jack B. Reaching women through health information technology: the Gabby preconception care system. Am J Health Promot. 2013 Jan-Feb;27(3 Suppl):eS11-20. doi: 10.4278/ajhp.1200113-QUAN-18.

  PMID: 23286652 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Methods

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Brian W Jack, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 18, 2013
• Study Start: February 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

US (1)