Randomized Control Trial of a Virtual Patient Advocate for Preconception Care

NCT01827215 | Completed

• 2 other identifiers: H-31633R01MD006213
• Study Type: interventional
• Target: 528
• 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 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.

Conditions

Preconception Care

Keywords

Preconception Care; Racial Disparities; Health Information Technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dose of Exposure to Virtual Patient Advocate (VPA) System

  12 months after enrollement (data gathered by online system throughout the 12 month intervention period)

• Subject Satisfaction with Virtual Patient Advocate (VPA) system

  12 months after enrollment

• Healthcare Provider Satisfaction

  Following the participant's appointment with a primary care provider, at any point during the 12 month intervention period

Study Arms (2)

Intervention (Virtual Patient Advocate)

EXPERIMENTAL

The Intervention Virtual Patient Advocate (VPA) Group participants 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 every two weeks or twice a month, 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 6 and 12 months to conduct a follow-up phone call to collect outcome data. At the end of the intervention period, intervention participants will be invited to participate a focus group session.

Behavioral: Virtual Patient Advocate (VPA)

Control (Letter)

NO INTERVENTION

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.

Interventions

Virtual Patient Advocate (VPA) BEHAVIORAL

Intervention participants will have access to the Virtual Patient Advocate (VPA) system for a period of 12 months. They will be encouraged to log on every two weeks or twice a month, but frequency and duration of conversations with the VPA is at the discretion of the participant.

Intervention (Virtual Patient Advocate)

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Do not speak English
• Self-reported pregnant at the time of enrollment

Sponsors & Collaborators

• Boston Medical Center: lead
• Northeastern University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• Gardiner P, Bickmore T, Yinusa-Nyahkoon L, Reichert M, Julce C, Sidduri N, Martin-Howard J, Woodhams E, Aryan J, Zhang Z, Fernandez J, Loafman M, Srinivasan J, Cabral H, Jack BW. Using Health Information Technology to Engage African American Women on Nutrition and Supplement Use During the Preconception Period. Front Endocrinol (Lausanne). 2021 Jan 19;11:571705. doi: 10.3389/fendo.2020.571705. eCollection 2020.

  PMID: 33584534 DERIVED

• Jack BW, Bickmore T, Yinusa-Nyahkoon L, Reichert M, Julce C, Sidduri N, Martin-Howard J, Zhang Z, Woodhams E, Fernandez J, Loafman M, Cabral HJ. Improving the health of young African American women in the preconception period using health information technology: a randomised controlled trial. Lancet Digit Health. 2020 Sep;2(9):e475-e485. doi: 10.1016/S2589-7500(20)30189-8.

  PMID: 33328115 DERIVED

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: April 5, 2013
• First Posted: April 9, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: January 1, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

US (1)