Using Virtual Counselors to Overcome Genetic Literacy Barriers

NCT ID: NCT02344433

Last Updated: 2019-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Disease Stroke Diabetes Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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VICKY

Relational agent, "virtual counselor" for collecting family health history (VICKY: VIrtual Counselor for Knowing Your Family History).

Group Type EXPERIMENTAL

VICKY

Intervention Type BEHAVIORAL

Relational agent/virtual counselor

MFHP

Online family health history collection tool (MFHP: My Family Health Portrait).

Group Type ACTIVE_COMPARATOR

MFHP

Intervention Type BEHAVIORAL

US Surgeon General's family history tool

Interventions

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VICKY

Relational agent/virtual counselor

Intervention Type BEHAVIORAL

MFHP

US Surgeon General's family history tool

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northeastern University

OTHER

Sponsor Role collaborator

National Human Genome Research Institute (NHGRI)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Catharine Wang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catharine Wang

Role: PRINCIPAL_INVESTIGATOR

Boston University

References

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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.

Reference Type DERIVED
PMID: 33750594 (View on PubMed)

Other Identifiers

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1R01HG007746-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-32767

Identifier Type: -

Identifier Source: org_study_id

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