Genome Driven Primary Care Clinics - an RCT

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04781205
• Other study ID #: CMC-16-0071-CTIL
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: December 2029

Study information

• Verified date: February 2021
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200000
• Est. completion date: December 2029
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All clinic adult population

• All diseases

Exclusion Criteria:

• Mentality unable to understand and sign consent

Related Conditions & MeSH terms

• Communicable Diseases
• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease
• Health Services Administration
• Infection
• Microbial Colonization

Intervention

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

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chronic diseases in clinic	whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer)	5 years
Primary	Mortality in clinic	whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD)	5 ytears
Primary	costs in clinic	Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization	5 years