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.
Verified date | February 2021 |
Source | Carmel Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Carmel Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Carmel Medical Center |
Israel,
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 |
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