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IRCT20221126056612N1 IRCT 2022-12-05 Ministry of Health and Medical Education Effectiveness of WHO HEARTS package in prevention and control of diabetes, hypertension, and hyperlipidemia in primary health care IRAN-HEARTS Evaluation of the WHO HEARTS package to improve control of cardiometabolic risk factors in the primary health care system 2023-01-21 anticipated 1400 Complete https://irct.ir/trial/67021 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: A community-based intervention trial. N/A Condition 1: Diabetes. Condition 2: Hypertension. Condition 3: Heart Disease. Condition 4: Hemorrhage Stroke. Condition 5: Hemorrhage Stroke. Condition 6: Ischemic Stroke. Intervention 1: Intervention group: Adopted WHO HEARTS technical package. The HEARTS technical package provides a strategic approach to improving cardiovascular health. It comprises six modules and an implementation guide. This package supports Ministries of Health to strengthen CVD management in primary care and aligns with WHO’s Package of Essential Noncommunicable Disease Interventions (WHO PEN). The HEARTS technical package includes the following modules: 1.The Healthy-lifestyle counselling module. This module focuses on the behavioral risk factors and provides information on: tobacco use, unhealthy diet, insufficient physical activity and harmful use of alcohol and also behavioral change, brief interventions for counselling and key points for motivational interviewing. 2. The Evidence-based protocols module uses hypertension and diabetes screening and treatment as an entry point to control cardiovascular risk factors, prevent target organ damage, and reduce premature morbidity and mortality. A comprehensive risk-based approach for integrated management of hypertension, diabetes, and high cholesterol is included in the Risk-based CVD management module. 3.The Access to essential medicines and technology module focuses on access to medicines and basic equipment for CVD management. 4. Risk-based CVD management module helps to identify those who would benefit from lifestyle changes and basic medical treatment to lower blood pressure, cholesterol, and manage diabetes mellitus in an integrated manner. The updated WHO CVD risk prediction charts were developed and presented for 21 global regions to maximize between-region variability and minimize heterogeneity in mortality and major drivers of health outcomes within each region. The charts are intended to allow the introduction of a total risk-stratification approach for management of CVD. They are presented as laboratory-based and non-laboratory-based charts. Laboratory-based algorithms include information on age, sex, smoking status, systolic blood pressure, history or evidence of diabetes mellitus, and the total cholesterol value. In the non-laboratory-based algorithms, body mass index (BMI) is included; information on diabetes mellitus and cholesterol is not necessary for these charts. 5. The Team-based care module uses multidisciplinary teams (which may involve new staff or the shifting of tasks among existing staff). Teams can include patients themselves, primary care physicians, and other allied health professionals, such as nurses, pharmacists, counsellors, social workers, nutritionists, community health workers, or others. Teams reduce the burden on physicians by utilizing the skills of trained health workers. 6. Systems for monitoring module provides a set of indicators on CVD management to allow progress to be monitored. In the current research, initially, the current IraPEN protocols will be adopted based on the HEARTS technical packages by conducting a qualitative study, and then the updated packages will be applied as an intervention in the intervention group. More information is available at: https://www.who.int/publications/i/item/9789240001367. Intervention 2: Control group: IraPEN programs for cardiometabolic disorders including routin tasks defined for physicians and health-workers in primary health care. In brief, in IraPEN, individuals aged 30 years and older were called for screening of cardiovascular risk factors and calculation of their 10-year CVD risk based on the WHO/ISH risk assessment chart for the Eastern Mediterranean region B, using smoking status, diabetes, systolic blood pressure, total cholesterol and age variables. According to this chart, people were placed in four risk groups as follows:1. Low risk (less than 10%); care, and risk assessment were followed annually. 2. Medium risk (10 to less than 20%); care, and risk assessment were followed every 9 months. 3. High risk (20 to less than 30%), care, and risk assessment were followed every 6 months. 4. Very High risk (30% and above), care, and risk assessment were followed every 3 months. Meanwhile, all individuals with diabetes, pre-diabetes, hypertension, and hypercholesterolemia are detected, educated, controlled and referred to physicians in systematic and scheduled packages. Follow-up and care of patients with hypertension and diabetes are done every month by Behvarz/health care provider and every 3 months by a physician. For patients with hyperlipidemia, pre-diabetes, and obesity, these follow-ups and care are done every 3 months by Behvarz/health care provider and they are referred to a physician if needed. All follow-ups and care are scheduled and registered through the electronic health information systems. More information is available at: https://health.sbmu.ac.ir/index.jsp?pageid=33694&p=1. No - There is not a plan to make this available Justification or reason for not sharing IPD is The current research is a community-based study. The extensive data collected in this study is registered in a national health information system and is confidential, and it is not possible to be shared.
public Leila Molaeipour
Crossroads of Chamran and Hemmat Expressways, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2243 2500 leilamolaei_epi@yahoo.com Iran University of Medical Sciences scientific Davood Khalili
Research Institute for Endocrine Sciences, No. 23, Arabi st., Velenjak
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2500 dkhalili@endocrine.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Adults aged 30 years or above Those with diabetes, hypertension, or hyperlipidemia or those with CVD/Diabetes risk of 10% or above 30 years no limit Both History of cardiovascular diseases Pregnancy Acute illness or medical emergency History of an Incurable disease E08 I10 I25 I60 I61 I63 Diabetes mellitus due to underlying condition Essential (primary) hypertension Chronic ischemic heart disease Nontraumatic subarachnoid hemorrhage Nontraumatic intracerebral hemorrhage Cerebral infarction Other Other Intervention group: Adopted WHO HEARTS technical package. The HEARTS technical package provides a strategic approach to improving cardiovascular health. It comprises six modules and an implementation guide. This package supports Ministries of Health to strengthen CVD management in primary care and aligns with WHO’s Package of Essential Noncommunicable Disease Interventions (WHO PEN). The HEARTS technical package includes the following modules: 1.The Healthy-lifestyle counselling module. This module focuses on the behavioral risk factors and provides information on: tobacco use, unhealthy diet, insufficient physical activity and harmful use of alcohol and also behavioral change, brief interventions for counselling and key points for motivational interviewing. 2. The Evidence-based protocols module uses hypertension and diabetes screening and treatment as an entry point to control cardiovascular risk factors, prevent target organ damage, and reduce premature morbidity and mortality. A comprehensive risk-based approach for integrated management of hypertension, diabetes, and high cholesterol is included in the Risk-based CVD management module. 3.The Access to essential medicines and technology module focuses on access to medicines and basic equipment for CVD management. 4. Risk-based CVD management module helps to identify those who would benefit from lifestyle changes and basic medical treatment to lower blood pressure, cholesterol, and manage diabetes mellitus in an integrated manner. The updated WHO CVD risk prediction charts were developed and presented for 21 global regions to maximize between-region variability and minimize heterogeneity in mortality and major drivers of health outcomes within each region. The charts are intended to allow the introduction of a total risk-stratification approach for management of CVD. They are presented as laboratory-based and non-laboratory-based charts. Laboratory-based algorithms include information on age, sex, smoking status, systolic blood pressure, history or evidence of diabetes mellitus, and the total cholesterol value. In the non-laboratory-based algorithms, body mass index (BMI) is included; information on diabetes mellitus and cholesterol is not necessary for these charts. 5. The Team-based care module uses multidisciplinary teams (which may involve new staff or the shifting of tasks among existing staff). Teams can include patients themselves, primary care physicians, and other allied health professionals, such as nurses, pharmacists, counsellors, social workers, nutritionists, community health workers, or others. Teams reduce the burden on physicians by utilizing the skills of trained health workers. 6. Systems for monitoring module provides a set of indicators on CVD management to allow progress to be monitored. In the current research, initially, the current IraPEN protocols will be adopted based on the HEARTS technical packages by conducting a qualitative study, and then the updated packages will be applied as an intervention in the intervention group. More information is available at: https://www.who.int/publications/i/item/9789240001367 Control group: IraPEN programs for cardiometabolic disorders including routin tasks defined for physicians and health-workers in primary health care. In brief, in IraPEN, individuals aged 30 years and older were called for screening of cardiovascular risk factors and calculation of their 10-year CVD risk based on the WHO/ISH risk assessment chart for the Eastern Mediterranean region B, using smoking status, diabetes, systolic blood pressure, total cholesterol and age variables. According to this chart, people were placed in four risk groups as follows:1. Low risk (less than 10%); care, and risk assessment were followed annually. 2. Medium risk (10 to less than 20%); care, and risk assessment were followed every 9 months. 3. High risk (20 to less than 30%), care, and risk assessment were followed every 6 months. 4. Very High risk (30% and above), care, and risk assessment were followed every 3 months. Meanwhile, all individuals with diabetes, pre-diabetes, hypertension, and hypercholesterolemia are detected, educated, controlled and referred to physicians in systematic and scheduled packages. Follow-up and care of patients with hypertension and diabetes are done every month by Behvarz/health care provider and every 3 months by a physician. For patients with hyperlipidemia, pre-diabetes, and obesity, these follow-ups and care are done every 3 months by Behvarz/health care provider and they are referred to a physician if needed. All follow-ups and care are scheduled and registered through the electronic health information systems. More information is available at: https://health.sbmu.ac.ir/index.jsp?pageid=33694&p=1 Hb A1c. Timepoint: 0,12 months. Method of measurement: Laboratory - enzymatic assay or using point of care. Blood Pressure. Timepoint: 0, 12 months. Method of measurement: Mercury or digital sphygmomanometer. Knowledge attitute and practice / Health literacy. Timepoint: 0, 12 months. Method of measurement: Validated questionnaires for Iranian population. Patient satisfaction. Timepoint: 0 and 12 months. Method of measurement: Validated questionnaires for Iranian population. Health System Staff satisfaction. Timepoint: 0 and 12 months. Method of measurement: Validated questionnaires for Iranian population. Adherence to treatment. Timepoint: 0 and 12 months. Method of measurement: Validated questionnaires for Iranian population. Fasting plasma glucose. Timepoint: 0 and 12 months. Method of measurement: Enzymatic lab measurements or using point of care. Total Cholesterol. Timepoint: 0 and 12 months. Method of measurement: Enzymatic lab measurements or using point of care. Cardiovascular risk score. Timepoint: 0 and 12 months. Method of measurement: CVD risk scoring model. Diabetes risk score. Timepoint: 0 and 12 months. Method of measurement: Diabetes risk scoring model. Taking glucose lowering drugs. Timepoint: 0 and 12 months. Method of measurement: Checklist. Taking blood pressure lowering drugs. Timepoint: 0 and 12 months. Method of measurement: Checklist. Taking lipid drugs. Timepoint: 0 and 12 months. Method of measurement: checklist. Ministry of Health and Medical Education Approved 2022-11-09 Ethics Committee of Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Research Institute for Endocrine Sciences, No.23, Arabi st, Velenjak Tehran Tehran Iran (Islamic Republic of)