Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT04781205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-03-04
First Post:
2021-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genome Driven Primary Care Clinics - an RCT
Sponsor:
Carmel Medical Center
Organization:
Study Overview
Official Title:
Operating Community Primary Care Clinics Under Personalized Medicine Paradigm and Determining Differences in Health Outcomes Between Clinics With and Without Intervention.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: