Using Virtual Counselors to Overcome Genetic Literacy Barriers
VICKY
2 other identifiers
interventional
279
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedOctober 24, 2019
October 1, 2019
2.9 years
January 12, 2015
October 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 +)
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)
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 Outcomes (1)
Family and provider communication (Communication of family health history with family members and health care providers)
Baseline and 3 month follow-up
Study Arms (2)
VICKY
EXPERIMENTALRelational agent, "virtual counselor" for collecting family health history (VICKY: VIrtual Counselor for Knowing Your Family History).
MFHP
ACTIVE COMPARATOROnline family health history collection tool (MFHP: My Family Health Portrait).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Under 21 years of age;
- not a current patient of Boston Medical Center or affiliated clinic;
- unable to speak English and/or Spanish.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Universitylead
- Northeastern Universitycollaborator
- National Human Genome Research Institute (NHGRI)collaborator
Related Publications (1)
Wang C, Paasche-Orlow MK, Bowen DJ, Cabral H, Winter MR, Norkunas Cunningham T, Trevino-Talbot M, Toledo DM, Cortes DE, Campion M, Bickmore T. Utility of a virtual counselor (VICKY) to collect family health histories among vulnerable patient populations: A randomized controlled trial. Patient Educ Couns. 2021 May;104(5):979-988. doi: 10.1016/j.pec.2021.02.034. Epub 2021 Feb 18.
PMID: 33750594DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catharine Wang
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 12, 2015
First Posted
January 26, 2015
Study Start
November 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
October 24, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share