Integrated Primary Care for Diabetes and Cardiovascular Disease (PACKBrazDCVD)
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ClinicalTrials.gov Identifier: NCT02795910 |
Recruitment Status : Unknown
Verified April 2018 by University of Sao Paulo General Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 10, 2016
Last Update Posted : April 30, 2018
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Sponsor:
University of Sao Paulo General Hospital
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
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
Tracking Information | ||||||||||
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First Submitted Date ICMJE | June 6, 2016 | |||||||||
First Posted Date ICMJE | June 10, 2016 | |||||||||
Last Update Posted Date | April 30, 2018 | |||||||||
Actual Study Start Date ICMJE | April 1, 2017 | |||||||||
Actual Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Integrated Primary Care for Diabetes and Cardiovascular Disease | |||||||||
Official Title ICMJE | Integrated Primary Care for Diabetes and Cardiovascular Disease in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit | |||||||||
Brief 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. 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 Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Bachmann MO, Bateman ED, Stelmach R, Cruz ÁA, 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. Review. | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Unknown status | |||||||||
Actual Enrollment ICMJE |
40577 | |||||||||
Original Estimated Enrollment ICMJE |
35000 | |||||||||
Estimated Study Completion Date ICMJE | March 31, 2019 | |||||||||
Actual Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 35 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | Brazil | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT02795910 | |||||||||
Other Study ID Numbers ICMJE | PACKBrazil2 | |||||||||
Has Data Monitoring Committee | No | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Sao Paulo General Hospital | |||||||||
Study Sponsor ICMJE | University of Sao Paulo General Hospital | |||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Sao Paulo General Hospital | |||||||||
Verification Date | April 2018 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |