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Completed

NCT Number: NCT02344433

Using Virtual Counselors to Overcome Genetic Literacy Barriers

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.

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Key information

Conditions

Heart Disease Brain Diseases Cancer Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Neoplasms Nervous System Diseases Nutritional and Metabolic Diseases Stroke Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VICKY

Behavioral

Relational agent/virtual counselor

MFHP

Behavioral

US Surgeon General's family history tool

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Human Genome Research Institute (NHGRI)
  • Northeastern University

Registry information

Official study title

Using Virtual Counselors to Overcome Genetic Literacy Barriers: Project VICKY

Acronym: VICKY

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2015
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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