Genome Driven Primary Care Clinics - an RCT

Condition(s) studied

Investigational drug(s) / intervention(s)

Mutation arrays, NGS panels, GWAS, WES, WGS,: DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces

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

Study 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).

Eligibility

Primary outcome measure(s)

• chronic diseases in clinic — 5 years
  whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer)
• Mortality in clinic — 5 ytears
  whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD)
• costs in clinic — 5 years
  Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization

Trial sites (1)

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