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ACTIVE NOT RECRUITING
NCT04781205
NA

Genome Driven Primary Care Clinics - an RCT

Sponsor: Carmel Medical Center

View on ClinicalTrials.gov

Summary

A cluster randomized controlled study of 40 primary care clinics in Northern Israel (20 intervention clinics, 20 usual care clinics) to evaluate the value of introducing a precision medicine/genomic approach/paradigm on the clinical and economical outcomes of the clinics. Intervention includes 3 elements: 1. DNA extraction and evaluation (up to the level of WGS); 2. Feces sample for microbiome study, 3. Wearable devices for continuous monitoring of body functions. Expected number of participants is 100,000 in each arm. Results will be calculated for a clinic as a unit and not for individuals (each clinic to be compared to "twin" selected clinic).

Official title: Operating Community Primary Care Clinics Under Personalized Medicine Paradigm and Determining Differences in Health Outcomes Between Clinics With and Without Intervention.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200000

Start Date

2019-05-01

Completion Date

2029-12

Last Updated

2021-03-04

Healthy Volunteers

No

Interventions

GENETIC

Mutation arrays, NGS panels, GWAS, WES, WGS,

DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces

DEVICE

wearable monitors

test various technologies of sensors to measure continuously various body functions and provide information to person and to physician

Locations (1)

Carmel Medical Center

Haifa, Israel