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Sponsored by: |
Ministry of Health, Malaysia |
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Information provided by: | Ministry of Health, Malaysia |
ClinicalTrials.gov Identifier: | NCT00490672 |
Randomized controlled trial of CORFIS Programme.
The study objectives are as follows:
Condition | Intervention | Phase |
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Hypertension Diabetes Mellitus Hyperlipidemia |
Behavioral: No Active Intervention. Behavioral: Community Based Multiple Risk Factor Intervention Strategies |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Community Based Multiple Risk Factors Intervention Strategy to Prevent Cardiovascular and Chronic Kidney Diseases [CORFIS] |
Estimated Enrollment: | 750 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control Arm: No Intervention
Conventional Patient Management on Hypertension, Diabetes Mellitus and Hyperlipidaemia by Malaysian GP
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Behavioral: No Active Intervention.
Conventional Chronic Disease Management in Malaysia Primary Care
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CORFIS Arm: Active Comparator
Community based Multiple Risk Factor Intervention Strategies
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Behavioral: Community Based Multiple Risk Factor Intervention Strategies
Multi-faceted Intervention in Chronic Diseases Management i.e. Hypertension, Diabetes Mellitus, Hyperlipidaemia involving Primary Health Care Physicians, Nurse Educators, Dieticians and Pharmacists.
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It should be obvious to all that we urgently need to improve the management of the various risk factors for cardiovascular (CVD) and chronic kidney diseases (CKD); the 3 most important of which are Hypertension (HT), Diabetes mellitus (DM), Hyperlipidaemias (HL). It is not just that these are highly prevalent in our community, they are also poorly managed and controlled, with resulting highly costly and adverse health impact on our population. It should also be equally obvious that we need a better approach to manage these risk factors in our community. There have been considerable advances in our understanding of these risk factors and in our knowledge of the variety of approaches to achieving control of these risk factors including the role of self-monitoring and self-management education, medical nutrition therapy, physical activity, psychological counseling, and various drug therapy options.
This study is a multi-center, open label, parallel group randomized trial designed to demonstrate the effectiveness of a community based multiple risk factors interventional strategy (CORFIS).
750 patients on treatment for HT, DM or HL from 75 general practices (GPs) who meet inclusion/exclusion criteria will be enrolled into the trial. Among the 75 selected GPs, 50 of them will be randomly allocated to CORFIS and 25 to routine care.
After initial screening, patients will attend clinic for baseline examination. Study prescribed visits for efficacy and safety assessments will occur monthly for 6 months. Hence there will be a total of 7 visits.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: Teck Onn Lim, FRCP | 03 26980310 | limto@crc.gov.my |
Contact: Wilson H Low, MSc Pri Care | 03 4044 3060 ext 226 | willow@crc.gov.my |
Principal Investigator: | Teck Onn Lim, FRCP | Ministry of Health, Malaysia |
Study Chair: | Zaki M Mohd Zaher, FRCP | International Medical University Malaysia |
Responsible Party: | Clinical Research Centre, Hospital Kuala Lumpur ( Dr. Lim Teck Onn ) |
Study ID Numbers: | CT07-02, NMRR ID Number: 447 |
Study First Received: | June 21, 2007 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00490672 |
Health Authority: | Malaysia: Ministry of Health |
Hypertension Diabetes Mellitus Hyperlipidaemia |
Primary Care Community Care Multiple Risk Factors Interventional Strategies |
Hyperlipidemias Metabolic Diseases Kidney Failure, Chronic Diabetes Mellitus Vascular Diseases Endocrine System Diseases Renal Insufficiency, Chronic |
Endocrinopathy Kidney Diseases Glucose Metabolism Disorders Metabolic disorder Dyslipidemias Hypertension Lipid Metabolism Disorders |
Cardiovascular Diseases |