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Active, Not Recruiting

NCT Number: NCT04781205

Genome Driven Primary Care Clinics - an RCT

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Health Services Administration Communicable Diseases Disease Attributes Disease Susceptibility Genetic Predisposition Genetic Predisposition to Disease Infections Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmel Medical Center

Haifa, 3436217, Israel

About this study

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

  • 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.
  • Examine whether the public has an interest in extensive genetic testing.
  • Examine whether the medical staff has an interest and ability to assimilate a genomic approach in the routine clinic work.
  • Identify links between genetic markers (mutations, variants) and different diseases (incidence or clinical behavior) or different drug responses (resistance, effectiveness, side-effects).
  • Examine whether the implementation of prolonged personal monitoring devices will lead to improved morbidity and mortality indices.
  • Examine whether measuring genomic variability in the microbiome has implications on health status or means of coping with different diseases and different health conditions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All clinic adult population
  • All diseases

Exclusion criteria

  • Mentality unable to understand and sign consent

Treatment and study plan

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

Genetic

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

wearable monitors

Device

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

Primary outcomes

  1. chronic diseases in clinic

    Time frame: 5 years

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

  2. Mortality in clinic

    Time frame: 5 ytears

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

  3. costs in clinic

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2029
First posted
Mar 4, 2021
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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