Using Virtual Counselors to Overcome Genetic Literacy Barriers (VICKY)

October 23, 2019 updated by: Catharine Wang, Boston University

Using Virtual Counselors to Overcome Genetic Literacy Barriers: Project VICKY

A Relational Agent (RA) "virtual counselor" (VICKY: VIrtual Counselor for Knowing Your Family History) has been developed to collect family health history information for common health conditions including heart disease, stroke, diabetes, hypertension and various cancers. In this study, the investigators will conduct a randomized controlled trial (RCT) to compare the efficacy of using VICKY to the existing My Family Health Portrait (MFHP) tool for collecting family health history information among an underserved primary care patient population. The primary aims of the study are to 1) evaluate the efficacy of VICKY versus MFHP for collecting accurate family health histories and 2) determine whether accuracy varies as a function of health literacy. This project will obtain validation data on the efficacy of both VICKY and MFHP for collecting accurate family history data among an underserved patient population, in two languages (English and Spanish). The study will determine whether a virtual counselor can overcome many of the existing barriers to using traditional web-based family history tools.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 21 years of age or older;
  • current Boston Medical Center patient - must have an upcoming returning patient appointment at Boston Medical Center or affiliated clinic within 3 months of recruitment;
  • speaks English and/or Spanish.

Exclusion Criteria:

  • Under 21 years of age;
  • not a current patient of Boston Medical Center or affiliated clinic;
  • unable to speak English and/or Spanish.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VICKY
Relational agent, "virtual counselor" for collecting family health history (VICKY: VIrtual Counselor for Knowing Your Family History).
Behavioral: VICKY
Relational agent/virtual counselor
Active Comparator: MFHP
Online family health history collection tool (MFHP: My Family Health Portrait).
Behavioral: MFHP
US Surgeon General's family history tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of health conditions id'd (interview w/ genetic counselor gold standard. health conditions id'd by VICKY or MFHP id'd by genetic counselor (true +) divided by health conditions captured by genetic counselor (false - plus true +)
Time Frame: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
Sensitivity will be calculated using an interview with a genetic counselor as the gold standard. Sensitivity will be defined as the health conditions identified by the family health history tool (VICKY or MFHP) that were also identified by the genetic counselor (true positive) divided by the health conditions not captured by the tool but captured by the genetic counselor (false negatives) plus the true positives.
Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
Accuracy of family members identified (defined as the agreement of first and second degree relatives identified by both the tool (VICKY or MFHP) and the genetic counselor)
Time Frame: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
Accuracy of family members identified will be defined as the agreement of first and second degree relatives identified by both the tool (VICKY or MFHP) and the genetic counselor.
Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family and provider communication (Communication of family health history with family members and health care providers)
Time Frame: Baseline and 3 month follow-up
Communication of family health history with family members and health care providers.
Baseline and 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

National Human Genome Research Institute (NHGRI)
Northeastern University

Investigators

  • Principal Investigator: Catharine Wang, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-32767
  • 1R01HG007746-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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