Genome Driven Primary Care Clinics

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial Description

Study major aim: Assess whether employing a paradigm of genomic/precision medicine in primary care clinics can lead to an improvement in the medical or economic outcomes of the clinic as a unit. Specific and secondary aims 1. Study differences in morbidity, mortality, quality of life or the cost of medical service indicators between clinics operating under a genome driven paradigm compared to usual care clinics. 2. Examine whether the public has an interest in extensive genetic testing. 3. Examine whether the medical staff has an interest and ability to assimilate a genomic approach in the routine clinic work. 4. Identify links between genetic markers (mutations, variants) and different diseases (incidence or clinical behavior) or different drug responses (resistance, effectiveness, side-effects). 5. Examine whether the implementation of prolonged personal monitoring devices will lead to improved morbidity and mortality indices. 6. Examine whether measuring genomic variability in the microbiome has implications on health status or means of coping with different diseases and different health conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04781205
Study type	Interventional
Source	Carmel Medical Center
Contact
Status	Active, not recruiting
Phase	N/A
Start date	May 1, 2019
Completion date	December 2029

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Genome Driven Primary Care Clinics - an RCT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms