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Using Virtual Counselors to Overcome Genetic Literacy Barriers

Using Virtual Counselors to Overcome Genetic Literacy Barriers: Project VICKY

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02344433
Acronym
VICKY
Enrollment
279
Registered
2015-01-26
Start date
2016-11-30
Completion date
2019-10-31
Last updated
2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Diabetes, Heart Disease, Stroke

Keywords

Family health history, Genetic literacy, Health literacy, Relational agent, Common chronic conditions

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.

Interventions

BEHAVIORALVICKY

Relational agent/virtual counselor

BEHAVIORALMFHP

US Surgeon General's family history tool

Sponsors

Northeastern University
CollaboratorOTHER
National Human Genome Research Institute (NHGRI)
CollaboratorNIH
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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 +)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.
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)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

MeasureTime frameDescription
Family and provider communication (Communication of family health history with family members and health care providers)Baseline and 3 month follow-upCommunication of family health history with family members and health care providers.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026