Genome Driven Primary Care Clinics - an RCT

NCT04781205 | Active Not Recruiting

• 1 other identifier: CMC-16-0071-CTIL
• Study Type: interventional
• Target: 200,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Health Services Administration; Genetic Predisposition; Microbial Colonization

Keywords

wearable monitors, microbiome, genomic medicine,

Outcome Measures

Primary Outcomes (3)

• chronic diseases in clinic

  whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer)

  5 years

• Mortality in clinic

  whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD)

  5 ytears

• costs in clinic

  Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization

  5 years

Study Arms (2)

Intervention

EXPERIMENTAL

Members of clinics randomized into intervention arm will be consented on a blood test for DNA evaluation (up to WGS), a single feces sample for microbiome analysis and tentative agreement to ware monitors of various vital signs of body function

Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,; Device: wearable monitors

Usual care

NO INTERVENTION

No intervention at all

Interventions

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

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

Intervention

wearable monitors DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All clinic adult population
• All diseases

You may not qualify if:

• Mentality unable to understand and sign consent

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, 3436217, Israel

Location

MeSH Terms

Conditions

Genetic Predisposition to Disease; Communicable Diseases

Interventions

Genome-Wide Association Study; Whole Genome Sequencing

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Molecular Epidemiology; Genetic Association Studies; Genetic Techniques; Oligonucleotide Array Sequence Analysis; Sequence Analysis; Public Health; Environment and Public Health; Sequence Analysis, DNA

Study Officials

• Gad Rennert, MD, PhD

  Clalit National Cancer Control Center Carmel Medical Center, Technion,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Dept. of Community Medicine and Epidemiology

Model Details: Paired cluster randomization of 40 clinics into 20 intervention and 20 usual care. Randomization from among a couple of similar clinics

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: March 4, 2021
• Study Start: May 1, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)