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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055106', 'term': 'Genome-Wide Association Study'}, {'id': 'D000073336', 'term': 'Whole Genome Sequencing'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017720', 'term': 'Molecular Epidemiology'}, {'id': 'D056726', 'term': 'Genetic Association Studies'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D020411', 'term': 'Oligonucleotide Array Sequence Analysis'}, {'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D017422', 'term': 'Sequence Analysis, DNA'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Paired cluster randomization of 40 clinics into 20 intervention and 20 usual care. Randomization from among a couple of similar clinics'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-28', 'studyFirstSubmitDate': '2021-02-14', 'studyFirstSubmitQcDate': '2021-02-28', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chronic diseases in clinic', 'timeFrame': '5 years', 'description': 'whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer)'}, {'measure': 'Mortality in clinic', 'timeFrame': '5 ytears', 'description': 'whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD)'}, {'measure': 'costs in clinic', 'timeFrame': '5 years', 'description': 'Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wearable monitors, microbiome, genomic medicine,'], 'conditions': ['Health Services Administration', 'Genetic Predisposition', 'Microbial Colonization']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'Study major aim:\n\nAssess 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.\n\nSpecific and secondary aims\n\n1. 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.\n2. Examine whether the public has an interest in extensive genetic testing.\n3. Examine whether the medical staff has an interest and ability to assimilate a genomic approach in the routine clinic work.\n4. Identify links between genetic markers (mutations, variants) and different diseases (incidence or clinical behavior) or different drug responses (resistance, effectiveness, side-effects).\n5. Examine whether the implementation of prolonged personal monitoring devices will lead to improved morbidity and mortality indices.\n6. Examine whether measuring genomic variability in the microbiome has implications on health status or means of coping with different diseases and different health conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All clinic adult population\n* All diseases\n\nExclusion Criteria:\n\n* Mentality unable to understand and sign consent'}, 'identificationModule': {'nctId': 'NCT04781205', 'briefTitle': 'Genome Driven Primary Care Clinics - an RCT', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Operating Community Primary Care Clinics Under Personalized Medicine Paradigm and Determining Differences in Health Outcomes Between Clinics With and Without Intervention.', 'orgStudyIdInfo': {'id': 'CMC-16-0071-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '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', 'interventionNames': ['Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,', 'Device: wearable monitors']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'No intervention at all'}], 'interventions': [{'name': 'Mutation arrays, NGS panels, GWAS, WES, WGS,', 'type': 'GENETIC', 'description': 'DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces', 'armGroupLabels': ['Intervention']}, {'name': 'wearable monitors', 'type': 'DEVICE', 'description': 'test various technologies of sensors to measure continuously various body functions and provide information to person and to physician', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3436217', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Gad Rennert, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clalit National Cancer Control Center Carmel Medical Center, Technion,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'study comparative unit is a whole clinic and not an individual participants'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman, Dept. of Community Medicine and Epidemiology', 'investigatorFullName': 'Gad Rennert', 'investigatorAffiliation': 'Carmel Medical Center'}}}}