Clinical trial NCT02344433: Using Virtual Counselors to Overcome Genetic Literacy Barriers
Official title: Using Virtual Counselors to Overcome Genetic Literacy Barriers: Project VICKY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Stroke
Diabetes
Cancer
Keywords: Family health history
Genetic literacy
Health literacy
Relational agent
Common chronic conditions
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: National Human Genome Research Institute (NHGRI)
First posted: 2015-01-26
Enrollment: 279
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility 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.

Primary outcomes:
measure: 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 +)
timeFrame: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
measure: 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)
timeFrame: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
Secondary outcomes:
measure: Family and provider communication (Communication of family health history with family members and health care providers)
timeFrame: Baseline and 3 month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Boston University
name: Catharine Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.