Health Services AdministrationNCT04781205
Genome Driven Primary Care Clinics - an RCT
A study testing Mutation arrays, NGS panels, GWAS, WES, WGS, and wearable monitors in people with Health Services Administration and Genetic Predisposition, run by Carmel Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Services Administration, Genetic Predisposition, Microbial Colonization
- What is being tested?
- Mutation arrays, NGS panels, GWAS, WES, WGS, and wearable monitors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2019to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All clinic adult population
- All diseases
Who cannot join
- Mentality unable to understand and sign consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operating Community Primary Care Clinics Under Personalized Medicine Paradigm and Determining Differences in Health Outcomes Between Clinics With and Without Intervention.
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).
Read the 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
- 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.
- Being tested
- Mutation arrays, NGS panels, GWAS, WES, WGS,, wearable monitors
- Keywords
- wearable monitors, microbiome, genomic medicine,
- Medical subject headings
- Genetic Predisposition to Disease, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mutation arrays, NGS panels, GWAS, WES, WGS,Genetic
DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces
wearable monitorsDevice
test various technologies of sensors to measure continuously various body functions and provide information to person and to physician
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,; Device: wearable monitors |
| Usual care | No intervention | No intervention at all |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic diseases in clinic
whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer)
Measured: 5 years
Mortality in clinic
whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD)
Measured: 5 ytears
costs in clinic
Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 May 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Services AdministrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paired cluster randomization of 40 clinics into 20 intervention and 20 usual care. Randomization from among a couple of similar clinics
- Masking
- None (open label)
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gad Rennert, Carmel Medical Center
- Investigators
- Gad Rennert, MD, PhD, Principal investigator, Clalit National Cancer Control Center Carmel Medical Center, Technion,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781205
- Sponsor's protocol ID
- CMC-16-0071-CTIL
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: study comparative unit is a whole clinic and not an individual participants
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operating Community Primary Care Clinics Under Personalized Medicine Paradigm and Determining Differences in Health Outcomes Between Clinics With and Without Intervention.
- ClinicalTrials.gov ID
- NCT04781205
- Acronym / sponsor ID
- CMC-16-0071-CTIL
- Keywords
- wearable monitors, microbiome, genomic medicine,
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Paired cluster randomization of 40 clinics into 20 intervention and 20 usual care. Randomization from among a couple of similar clinics
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Genetic: Mutation arrays, NGS panels, GWAS, WES, WGS,, Device: wearable monitorsMembers 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 |
| Usual care | No intervention | –No intervention at all |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All clinic adult population
- All diseases
Key exclusion criteria (1 listed)
- Mentality unable to understand and sign consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mutation arrays, NGS panels, GWAS, WES, WGS,DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces | Genetic | Intervention |
| wearable monitorstest various technologies of sensors to measure continuously various body functions and provide information to person and to physician | Device | Intervention |
Primary outcome
chronic diseases in clinic
Time frame: 5 years
whole clinic Incidence rate/100,000 of major chronic diseases (hypertension, Hyperlipidemia, DM, IHD, Cancer)
Mortality in clinic
Time frame: 5 ytears
whole clinic mortality rate/100,000 of major chronic diseases (DM, cancer, IHD)
costs in clinic
Time frame: 5 years
Total annual cost of clinic activity in NIS, including cost of diagnostic tests and hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Individual participant dataSharing planned: No. study comparative unit is a whole clinic and not an individual participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gad Rennert, MD, PhD principal investigator
Clalit National Cancer Control Center Carmel Medical Center, Technion,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mutation arrays, NGS panels, GWAS, WES, WGS, and wearable monitors in people with Health Services Administration and Genetic Predisposition, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic diseases in clinic (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.