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临床试验/NCT02344433
NCT02344433已完成不适用

Using Virtual Counselors to Overcome Genetic Literacy Barriers: Project VICKY

Boston University0 个研究点目标入组 279 人开始时间: 2016年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
279
主要终点
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)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Under 21 years of age;
  • not a current patient of Boston Medical Center or affiliated clinic;
  • unable to speak English and/or Spanish.

研究组 & 干预措施

VICKY

Experimental

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

干预措施: VICKY (Behavioral)

MFHP

Active Comparator

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

干预措施: MFHP (Behavioral)

结局指标

主要结局

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)

时间窗: 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.

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 +)

时间窗: 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.

次要结局

  • Family and provider communication (Communication of family health history with family members and health care providers)(Baseline and 3 month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catharine Wang

Associate Professor

Boston University

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