Diabetes MellitusPACKBrazDCVDNCT02795910
Integrated Primary Care for Diabetes and Cardiovascular Disease
A study testing Outreach education training and No outreach education training in people with Diabetes Mellitus and Hypertension, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Heart Failure
- What is being tested?
- Outreach education training and No outreach education training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,577 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35 years and over in July 2016
- Diagnosis of hypertension (ICD-10 code I10-I15), ischaemic heart disease (ICD-10 code I20-I25), heart failure (ICD-10 code I50), cerebrovascular disease (ICD-10 code I60-I69), or diabetes mellitus (ICD-10 code E10-E14) ever recorded since January 1st 2010, and attended a participating clinic for any reason during the first year of the trial
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Florianopolis City Health Department
Florianópolis, Santa Catarina, 88.040-400
About this study
Official title: Integrated Primary Care for Diabetes and Cardiovascular Disease in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit
This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of primary health care and health outcomes, in adults with diabetes and cardiovascular disease (CVD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 11000 patients known to have been diagnosed with diabetes mellitus and 32000 with CVD (defined as having a diagnosis of hypertension, ischemic heart disease, heart failure or cerebrovascular disease) in participating clinics will be included in the study. About 7800 of them have diagnoses of both CVD and stroke. The primary endpoints will be 1. Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate diagnosis of comorbid conditions such as depression. Eligible patients will be identified and outcomes measured using electronic medical records.
Read the detailed description
Diabetes mellitus and cardiovascular disease (diabetes and CVD) place a heavy and growing burden on people living in low and middle income countries. Many of them could be healthier if their disease was accurately diagnosed and correctly treated, but many are not. Doctors and nurses working in primary health care clinic are best placed people to diagnose and treat, especially where local clinics are near and free. But this raises two questions: 1. How to ensure that diabetes and CVD get the priority they need in overloaded clinics? 2. How to ensure rational evidence-based diagnosis and prescribing for diabetes and CVD? The investigators have developed a way of improving primary health care for people who have long term health conditions. It is a patient management tool (PMT), that is, a printed manual of flowcharts taking doctors and nurses from symptoms to diagnoses to treatments, tests or referrals, with advice on how to make decisions along the way about diagnoses, tests, treatments and referrals. They are prompted to think of other diseases and health problems that might be undetected or neglected. The package also includes a method of training known as outreach education. First trainers are trained, then trainers train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions. The investigators' research in Africa has shown that this approach can be effective, cost effective, feasible and sustainable. It has been rolled out throughout South Africa and other African countries. But it has have not yet been shown to be effective for diabetes and CVD. The investigators have also not tried or evaluate it in Latin American countries, which have different health systems, and have many more doctors providing primary health care. Now co-investigators in the Brazilian city of Florianopolis have decided to put this educational package in place throughout the city, and have agreed to do so as a randomised controlled trial. This will clearly show whether PACK Brazil is effective, cost effective and feasible under Brazilian conditions. The core of the research will be a randomised controlled trial. 48 primary care clinics in the city will be randomly chosen either 1) to get the whole package of patient management tool plus training, or 2) only to get the patient management tool (which is expected to will make little difference without training). The investigators will compare patients in these two groups of clinics to see the effects of the training. They will use the clinics' electronic medical records to identify about 32000 adults diagnosed with diabetes and CVD. After the training starts they will follow these patients up for a year, and assess whether they are being appropriately treated and tested. The primary endpoints will be 1. Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded. Secondary endpoints will include frequency of tests, the number who have each type of test, diastolic blood pressure in participants with hypertension, serum glucose levels in participants with diabetes, prescription of indicated treatments and treatment intensification, health measures (hospital admissions and deaths), and indicators of diagnosis and treatment of comorbid conditions such as depression. Eligible patients will be identified and outcomes measured using electronic medical records.
- Conditions
- Diabetes Mellitus, Hypertension, Heart Failure, Ischemic Heart Disease, Cerebrovascular Disease
- Being tested
- Outreach education training, No outreach education training
- Medical subject headings
- Diabetes Mellitus, Hypertension, Heart Failure, Myocardial Ischemia, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outreach education trainingBehavioural
Printed copies of the patient management tool (PMT) and outreach education training
No outreach education trainingBehavioural
Printed copies of the patient management tool (PMT) without outreach education training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) and outreach education training. First trainers will be trained, then trainers will train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions Receives: Behavioral: Outreach education training |
| Control | Active comparator | Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will receive no outreach education training. Receives: Behavioral: No outreach education training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk and diabetes testing
Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, glycated hemoglobin (HbA1c), serum cholesterol, electrocardiogram.
Measured: During the first year of the trial
Systolic blood pressure
In participants with a diagnosis of hypertension recorded previously, and with systolic blood pressure >140 mm Hg recorded during 12 months before start of follow up, average systolic blood pressure recorded
Measured: During the first year of the trial
Secondary outcomes (25)
Diastolic blood pressure
Number of tests for cardiovascular and diabetes risk factors (body mass index, plasma or skin prick glucose, serum cholesterol, electrocardiogram, chest X ray) recorded for each participant
Measured: During the first year of the trial
Number of tests
Number of tests for cardiovascular and diabetes risk factors (body mass index, plasma or skin prick glucose, serum cholesterol, electrocardiogram, chest X ray) recorded for each participant
Measured: During the first year of the trial
BMI measured
Number of participants who had body mass index recorded at least once
Measured: During the first year of the trial
Cholesterol tested
Number of participants who had serum cholesterol recorded at least once
Measured: During the first year of the trial
ECG tested
Number of participants who had electrocardiogram recorded at least once
Measured: During the first year of the trial
Chest X ray tested
Number of participants who had chest X ray recorded at least once
Measured: During the first year of the trial
Glucose tested
Number of participants who had plasma glucose recorded at least once
Measured: During the first year of the trial
Simvastatin prescribed
Number of participants in whom simvastatin was prescribed for the first time
Measured: During the first year of the trial
Simvastatin dose changed
Number of participants in whom dose of simvastatin was changed
Measured: During the first year of the trial
Depression diagnosed
Number of participants in whom a diagnosis of depression (ICD-10 code F32-F34) was recorded for the first time
Measured: During the first year of the trial
Antidepressant diagnosed
Number of participants in whom antidepressant medication (tricyclic and related antidepressants, selective serotonin re-uptake inhibitors, and monoamine oxidase inhibitors) was prescribed for the first time
Measured: During the first year of the trial
Heart failure diagnosed
Number of participants in whom a diagnosis of heart failure (ICD-10 code I50) was recorded for the first time
Measured: During the first year of the trial
Ischemic heart disease diagnosed
Number of participants in whom a diagnosis of heart failure (ICD-10 code I50) was recorded for the first time
Measured: During the first year of the trial
Cerebrovascular disease diagnosed
Number of participants in whom a diagnosis of cerebrovascular disease (ICD-10 code I60-I69) was recorded for the first time
Measured: During the first year of the trial
Angina referral
Number of participants referred to a hospital or specialist with a diagnosis of angina pectoris (ICD code I20)
Measured: During the first year of the trial
Hospital admission for CVD
Number of participants admitted to hospital for ischemic heart disease, heart failure, hypertension, cerebrovascular disease or peripheral vascular disease (ICD code I73)
Measured: During the first year of the trial
All cause mortality
Number of participants who died
Measured: During the first year of the trial
Death from CVD
Number of participants who died and in whom ischemic heart disease, heart failure, hypertension, or cerebrovascular disease was recorded as an underlying cause of death
Measured: During the first year of the trial
Any hypertension controlled
In participants with an average systolic blood pressure greater than 140 mm Hg, or an average diastolic blood pressure greater than 90 mm Hg, recorded during 12 months before enrolment, the number of participants with systolic blood pressure 140 mm Hg or less and with diastolic blood pressure 90 mm Hg or less
Measured: During the first year of the trial
Severe hypertension controlled
In participants with an average systolic blood pressure greater than 150 mm Hg, or an average diastolic blood pressure greater than 100 mm Hg, recorded during 12 months before enrolment, the number of participants with systolic blood pressure 140 mm Hg or less and with diastolic blood pressure 90 mm Hg or less
Measured: During the first year of the trial
Number of glucose tests
In participants with a diagnosis of diabetes, number of times plasma glucose or glycated hemoglobin (HbA1c) recorded
Measured: During the first year of the trial
Glycated hemoglobin (HbA1c)
In participants with a diagnosis of diabetes, average glycated hemoglobin (HbA1c) level recorded
Measured: During the first year of the trial
Heart failure treatment
In participants with a diagnosis of heart failure, the number of new prescriptions for furosemide, hydrochlorothiazide, enalapril or carvedilol
Measured: During the first year of the trial
Increased hypertension treatment
In participants with a diagnosis of hypertension, the number of participants with a prescription for increased dose of hydrochlorothiazide, enalapril, amlodipine or propanalol
Measured: During the first year of the trial
Ischemic heart disease treatment
In participants with a diagnosis of ischemic heart disease, then number of participants with a new prescription of angiotensin converting enzyme inhibitor, isosorbide dinitrate, propanalol, enalapril or losartan
Measured: During the first year of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start1 Apr 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40,577 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Santa Catarina Federal University, University of Cape Town, Federal University of Bahia, Medical Research Council, South Africa, University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Max Bachmann, MBChB PhD, Principal investigator, University of East AngliaEric Bateman, MBChB MD, Principal investigator, University of Cape TownRafael Stelmach, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795910
- Sponsor's protocol ID
- PACKBrazil2
- Acronym
- PACKBrazDCVD
- Status last verified
- Apr 2018
- First submitted
- 6 Jun 2016
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick R, Wattrus C, Anderson L, Lombard C, Fairall LR. Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials. J Thorac Dis. 2018 Jul;10(7):4667-4677. doi: 10.21037/jtd.2018.07.34.
PubMed 30174920
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Primary Care for Diabetes and Cardiovascular Disease in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit
- ClinicalTrials.gov ID
- NCT02795910
- Acronym / sponsor ID
- PACKBrazDCVD / PACKBrazil2
- Conditions
- Diabetes Mellitus, Hypertension, Heart Failure, Ischemic Heart Disease, Cerebrovascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40,577 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Santa Catarina Federal University, University of Cape Town, Federal University of Bahia, Medical Research Council, South Africa, University of East Anglia
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- 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.
This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of primary health care and health outcomes, in adults with diabetes and cardiovascular disease (CVD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 11000 patients known to have been diagnosed with diabetes mellitus and 32000 with CVD (defined as having a diagnosis of hypertension, ischemic heart disease, heart failure or cerebrovascular disease) in participating clinics will be included in the study. About 7800 of them have diagnoses of both CVD and stroke. The primary endpoints will be 1. Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate diagnosis of comorbid conditions such as depression. Eligible patients will be identified and outcomes measured using electronic medical records.
Detailed description
Diabetes mellitus and cardiovascular disease (diabetes and CVD) place a heavy and growing burden on people living in low and middle income countries. Many of them could be healthier if their disease was accurately diagnosed and correctly treated, but many are not. Doctors and nurses working in primary health care clinic are best placed people to diagnose and treat, especially where local clinics are near and free. But this raises two questions: 1. How to ensure that diabetes and CVD get the priority they need in overloaded clinics? 2. How to ensure rational evidence-based diagnosis and prescribing for diabetes and CVD? The investigators have developed a way of improving primary health care for people who have long term health conditions. It is a patient management tool (PMT), that is, a printed manual of flowcharts taking doctors and nurses from symptoms to diagnoses to treatments, tests or referrals, with advice on how to make decisions along the way about diagnoses, tests, treatments and referrals. They are prompted to think of other diseases and health problems that might be undetected or neglected. The package also includes a method of training known as outreach education. First trainers are trained, then trainers train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions. The investigators' research in Africa has shown that this approach can be effective, cost effective, feasible and sustainable. It has been rolled out throughout South Africa and other African countries. But it has have not yet been shown to be effective for diabetes and CVD. The investigators have also not tried or evaluate it in Latin American countries, which have different health systems, and have many more doctors providing primary health care. Now co-investigators in the Brazilian city of Florianopolis have decided to put this educational package in place throughout the city, and have agreed to do so as a randomised controlled trial. This will clearly show whether PACK Brazil is effective, cost effective and feasible under Brazilian conditions. The core of the research will be a randomised controlled trial. 48 primary care clinics in the city will be randomly chosen either 1) to get the whole package of patient management tool plus training, or 2) only to get the patient management tool (which is expected to will make little difference without training). The investigators will compare patients in these two groups of clinics to see the effects of the training. They will use the clinics' electronic medical records to identify about 32000 adults diagnosed with diabetes and CVD. After the training starts they will follow these patients up for a year, and assess whether they are being appropriately treated and tested. The primary endpoints will be 1. Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded. Secondary endpoints will include frequency of tests, the number who have each type of test, diastolic blood pressure in participants with hypertension, serum glucose levels in participants with diabetes, prescription of indicated treatments and treatment intensification, health measures (hospital admissions and deaths), and indicators of diagnosis and treatment of comorbid conditions such as depression. Eligible patients will be identified and outcomes measured using electronic medical records.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Outreach education trainingDoctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) and outreach education training. First trainers will be trained, then trainers will train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions |
| Control | Active comparator | Behavioral: No outreach education trainingDoctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will receive no outreach education training. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 35 years and over in July 2016
- Diagnosis of hypertension (ICD-10 code I10-I15), ischaemic heart disease (ICD-10 code I20-I25), heart failure (ICD-10 code I50), cerebrovascular disease (ICD-10 code I60-I69), or diabetes mellitus (ICD-10 code E10-E14) ever recorded since January 1st 2010, and attended a participating clinic for any reason during the first year of the trial
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Outreach education trainingPrinted copies of the patient management tool (PMT) and outreach education training | Behavioural | Intervention |
| No outreach education trainingPrinted copies of the patient management tool (PMT) without outreach education training | Behavioural | Control |
Primary outcome
Cardiovascular risk and diabetes testing
Time frame: During the first year of the trial
Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, glycated hemoglobin (HbA1c), serum cholesterol, electrocardiogram.
Systolic blood pressure
Time frame: During the first year of the trial
In participants with a diagnosis of hypertension recorded previously, and with systolic blood pressure >140 mm Hg recorded during 12 months before start of follow up, average systolic blood pressure recorded
25 secondary outcomes
Diastolic blood pressure
Time frame: During the first year of the trial
Number of tests
Time frame: During the first year of the trial
BMI measured
Time frame: During the first year of the trial
Cholesterol tested
Time frame: During the first year of the trial
ECG tested
Time frame: During the first year of the trial
Chest X ray tested
Time frame: During the first year of the trial
Glucose tested
Time frame: During the first year of the trial
Simvastatin prescribed
Time frame: During the first year of the trial
Simvastatin dose changed
Time frame: During the first year of the trial
Depression diagnosed
Time frame: During the first year of the trial
Antidepressant diagnosed
Time frame: During the first year of the trial
Heart failure diagnosed
Time frame: During the first year of the trial
Ischemic heart disease diagnosed
Time frame: During the first year of the trial
Cerebrovascular disease diagnosed
Time frame: During the first year of the trial
Angina referral
Time frame: During the first year of the trial
Hospital admission for CVD
Time frame: During the first year of the trial
All cause mortality
Time frame: During the first year of the trial
Death from CVD
Time frame: During the first year of the trial
Any hypertension controlled
Time frame: During the first year of the trial
Severe hypertension controlled
Time frame: During the first year of the trial
Number of glucose tests
Time frame: During the first year of the trial
Glycated hemoglobin (HbA1c)
Time frame: During the first year of the trial
Heart failure treatment
Time frame: During the first year of the trial
Increased hypertension treatment
Time frame: During the first year of the trial
Ischemic heart disease treatment
Time frame: During the first year of the trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Derived from this study: PubMed 30174920Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick R, Wattrus C, Anderson L, Lombard C, Fairall LR. Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials. J Thorac Dis. 2018 Jul;10(7):4667-4677. doi: 10.21037/jtd.2018.07.34.
- Individual participant dataSharing planned: No
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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.
Max Bachmann, MBChB PhD principal investigator
University of East Anglia
Eric Bateman, MBChB MD principal investigator
University of Cape Town
Rafael Stelmach, MD PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outreach education training and No outreach education training in people with Diabetes Mellitus and Hypertension, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 30 Apr 2018. 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 Brazil. 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?
Results are not available in the source record.
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?
Cardiovascular risk and diabetes testing (time frame: During the first year of the trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795910, which also lists 1 linked publication.
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 30 Apr 2018.