An interventional study of VICKY and MFHP in Heart Disease, Stroke and Diabetes, sponsored by Boston University. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-24.
Sponsored by Boston University · Not applicable, Interventional, and Screening
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.
3,674 studies on the registry are indexed under Heart Diseases; 458 are open to participants now.
This study's enrollment of 279 is above the median of 100 across 1,785 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Boston University is the lead sponsor of 270 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
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Exclusion Criteria:
Relational agent, "virtual counselor" for collecting family health history (VICKY: VIrtual Counselor for Knowing Your Family History).
Behavioral: VICKY
Online family health history collection tool (MFHP: My Family Health Portrait).
Behavioral: MFHP
Relational agent/virtual counselor
US Surgeon General's family history tool
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 +)
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.
Time frame: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
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)
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.
Time frame: Computed value derived from baseline assessments of family health history (both tool and counselor-obtained histories).
Family and provider communication (Communication of family health history with family members and health care providers)
Communication of family health history with family members and health care providers.
Time frame: Baseline and 3 month follow-up
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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