Integrated Primary Care for Diabetes and Cardiovascular Disease (PACKBrazDCVD)
Integrated Primary Care for Diabetes and Cardiovascular Disease in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Santa Catarina
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Florianopolis, Santa Catarina, Brazil, 88.040-400
- Florianopolis City Health Department
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Intervention
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
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Printed copies of the patient management tool (PMT) and outreach education training
|
|
Active Comparator: Control
Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will receive no outreach education training.
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Printed copies of the patient management tool (PMT) without outreach education training
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During the first year of the trial
|
|
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
|
During the first year of the trial
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diastolic blood pressure
Time Frame: During the first year of the trial
|
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
|
During the first year of the trial
|
|
Number of tests
Time Frame: During the first year of the trial
|
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
|
During the first year of the trial
|
|
BMI measured
Time Frame: During the first year of the trial
|
Number of participants who had body mass index recorded at least once
|
During the first year of the trial
|
|
Cholesterol tested
Time Frame: During the first year of the trial
|
Number of participants who had serum cholesterol recorded at least once
|
During the first year of the trial
|
|
ECG tested
Time Frame: During the first year of the trial
|
Number of participants who had electrocardiogram recorded at least once
|
During the first year of the trial
|
|
Chest X ray tested
Time Frame: During the first year of the trial
|
Number of participants who had chest X ray recorded at least once
|
During the first year of the trial
|
|
Glucose tested
Time Frame: During the first year of the trial
|
Number of participants who had plasma glucose recorded at least once
|
During the first year of the trial
|
|
Simvastatin prescribed
Time Frame: During the first year of the trial
|
Number of participants in whom simvastatin was prescribed for the first time
|
During the first year of the trial
|
|
Simvastatin dose changed
Time Frame: During the first year of the trial
|
Number of participants in whom dose of simvastatin was changed
|
During the first year of the trial
|
|
Depression diagnosed
Time Frame: During the first year of the trial
|
Number of participants in whom a diagnosis of depression (ICD-10 code F32-F34) was recorded for the first time
|
During the first year of the trial
|
|
Antidepressant diagnosed
Time Frame: During the first year of the trial
|
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
|
During the first year of the trial
|
|
Heart failure diagnosed
Time Frame: During the first year of the trial
|
Number of participants in whom a diagnosis of heart failure (ICD-10 code I50) was recorded for the first time
|
During the first year of the trial
|
|
Ischemic heart disease diagnosed
Time Frame: During the first year of the trial
|
Number of participants in whom a diagnosis of heart failure (ICD-10 code I50) was recorded for the first time
|
During the first year of the trial
|
|
Cerebrovascular disease diagnosed
Time Frame: During the first year of the trial
|
Number of participants in whom a diagnosis of cerebrovascular disease (ICD-10 code I60-I69) was recorded for the first time
|
During the first year of the trial
|
|
Angina referral
Time Frame: During the first year of the trial
|
Number of participants referred to a hospital or specialist with a diagnosis of angina pectoris (ICD code I20)
|
During the first year of the trial
|
|
Hospital admission for CVD
Time Frame: During the first year of the trial
|
Number of participants admitted to hospital for ischemic heart disease, heart failure, hypertension, cerebrovascular disease or peripheral vascular disease (ICD code I73)
|
During the first year of the trial
|
|
All cause mortality
Time Frame: During the first year of the trial
|
Number of participants who died
|
During the first year of the trial
|
|
Death from CVD
Time Frame: During the first year of the trial
|
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
|
During the first year of the trial
|
|
Any hypertension controlled
Time Frame: During the first year of the trial
|
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
|
During the first year of the trial
|
|
Severe hypertension controlled
Time Frame: During the first year of the trial
|
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
|
During the first year of the trial
|
|
Number of glucose tests
Time Frame: During the first year of the trial
|
In participants with a diagnosis of diabetes, number of times plasma glucose or glycated hemoglobin (HbA1c) recorded
|
During the first year of the trial
|
|
Glycated hemoglobin (HbA1c)
Time Frame: During the first year of the trial
|
In participants with a diagnosis of diabetes, average glycated hemoglobin (HbA1c) level recorded
|
During the first year of the trial
|
|
Heart failure treatment
Time Frame: During the first year of the trial
|
In participants with a diagnosis of heart failure, the number of new prescriptions for furosemide, hydrochlorothiazide, enalapril or carvedilol
|
During the first year of the trial
|
|
Increased hypertension treatment
Time Frame: During the first year of the trial
|
In participants with a diagnosis of hypertension, the number of participants with a prescription for increased dose of hydrochlorothiazide, enalapril, amlodipine or propanalol
|
During the first year of the trial
|
|
Ischemic heart disease treatment
Time Frame: During the first year of the trial
|
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
|
During the first year of the trial
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Max Bachmann, MBChB PhD, University of East Anglia
- Principal Investigator: Eric Bateman, MBChB MD, University of Cape Town
- Principal Investigator: Rafael Stelmach, MD PhD, University of Sao Paulo
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Coronary Disease
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Cardiovascular Diseases
- Diabetes Mellitus
- Cerebrovascular Disorders
Other Study ID Numbers
Other Study ID Numbers
- PACKBrazil2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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