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Using Virtual Counselors to Overcome Genetic Literacy Barriers (VICKY)

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ClinicalTrials.gov Identifier: NCT02344433
Recruitment Status : Enrolling by invitation
First Posted : January 26, 2015
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Northeastern University
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Catharine Wang, Boston University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Disease Stroke Diabetes Cancer Behavioral: VICKY Behavioral: MFHP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Using Virtual Counselors to Overcome Genetic Literacy Barriers: Project VICKY
Actual Study Start Date : November 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT02344433


Sponsors and Collaborators
Boston University
Northeastern University
National Human Genome Research Institute (NHGRI)
Investigators
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Principal Investigator: Catharine Wang Boston University

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Responsible Party: Catharine Wang, Associate Professor, Boston University
ClinicalTrials.gov Identifier: NCT02344433     History of Changes
Other Study ID Numbers: H-32767
1R01HG007746-01 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catharine Wang, Boston University:
Family health history
Genetic literacy
Health literacy
Relational agent
Common chronic conditions

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases