Family History in a Singaporean Healthy Population

Integration of Family Health History Data Into a Singaporean Healthy Population Cohort Database to Understand the Associations Between Family Health History and Genomics

The purpose of this study is to better understand the linkages between family health history (FHH) and genomics in a Singaporean population. Secondly this study will evaluate the facilitators and barriers to implementation of a family history collection and risk assessment tool within a Singaporean population.

Study Overview

• Status: Recruiting
• Conditions: All
• Intervention / Treatment: Genetic: MeTree

Detailed Description

This study is a collaboration between Duke University School of Medicine Center for Applied Genomics and Precision Medicine (CAGPM) and the National Heart Center of Singapore (NHCS) and SingHealth Duke-NUS Center for Precision Medicine (PRISM). The NHCS study, Molecular and Imaging Studies of Cardiovascular Health and Disease ("Biobank study") is collecting genomic, clinical, and environmental data on a large cohort of healthy Singaporean volunteers. Data from the Biobank study is being deposited into a large healthy population cohort database, SPECTRA, organized under PRISM. The investigators will collaborate with the NHCS Biobank study and PRISM to integrate the Duke family history risk assessment platform, MeTree, into the data collection of the Biobank study cohort for in-depth analyses of FHH and genomic associations as well as exploration of the feasibility of MeTree implementation into the Singaporean clinical context. The Biobank study is a prospective observational study. It has already enrolled 1,000 subjects and will continue enrollment over the next year and possibly beyond. Previously enrolled subjects will be re-contacted for completion of MeTree as well as having future enrollees complete the tool prospectively. The investigators anticipate 5,000 subjects completing MeTree over a one-year period. The investigators will evaluate the feasibility and effectiveness of implementing MeTree in the larger Singaporean context. The investigators will assess implementation related outcomes- questions/problems people have when completing their family histories, how complete are the FHH entered, what types of risk are identified and what existing programs in Singapore are designed to manage that risk. The completion of this project will provide a significant amount of data to better understand the associations between FHH and genomic data within a healthy Asian population. It also will result in a better understanding of an appropriate implementation strategy for MeTree within the Singaporean clinical setting.

Specific Aim 1: To explore the correlation of genomic data and FHH within a healthy Asian population.

Specific Aim 2: To assess the clinical utility and appropriateness of a patient-entered FHH risk assessment tool within a Singaporean population.

Specific Aim 3: To create an implementation strategy for broader implementation of a patient-driven risk assessment tool in Singapore.

Duke University will be providing access to the MeTree Family Health History tool, storage of the PRISM participant data, participant and provider risk assessment reports, and education about the tool to PRISM study staff as needed. Duke University personnel will not be involved in any recruiting, consenting, or follow-up with study participants, but will have access to de-identified participant data housed in the MeTree research database in order to provide support for the study coordinators for participant account trouble-shooting and also to provide interim and final datasets to the PRISM statisticians. The MeTree research database currently sits on a DHTS server behind the Duke firewall, and is maintained and secure in accordance with Duke policy for patient data.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Lori Orlando, MD; Phone Number: 919 660-6606; Email: lori.orlando@duke.edu
• Study Contact Backup: Name: Ryanne Wu, MD; Phone Number: 919 668-7205; Email: ryanne.wu@duke.edu

Study Locations

• Singapore
  • Singapore, Singapore, 574116
    • Recruiting
    • National Heart Centre of Singapore
    • Contact: Ryanne R Wu, MD; Email: ryanne.wu@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy Singaporean population

Description

Inclusion Criteria:

• Healthy Singaporeans enrolled or eligible for enrollment in a local Biobank protocol

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of genomic data and family health history (FHH) within a healthy Asian population.	assess whether family history driven risk results correlate with findings on genetic results	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical utility and appropriateness of a patient-entered FHH risk assessment tool within a Singaporean population	Determine whether US guideline driven risk assessment has any clinical value in Singapore	Baseline
Facilitators and barriers to using systemic risk assessment tool in Singapore	Identify facilitators and barriers to using risk assessment tool in order to create a strategy for broader implementation of a patient-driven risk assessment tool in Singapore	Baseline

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Lori Orlando, MD, Associate Professor of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2017
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: prevention; clinical decision support; genetic risk; family health history
• Other Study ID Numbers: Pro00079760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No