Community Based Multiple Risk Factors Intervention Strategy (CORFIS)
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|ClinicalTrials.gov Identifier: NCT00490672|
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : April 7, 2015
Randomized controlled trial of CORFIS Programme.
The study objectives are as follows:
- To determine the efficacy of a community based multiple risk factors interventional strategy (CORFIS) for a treatment period of 6 months in patients on treatment for HT, DM or HL.
- The intervention shall consist of a purpose design and systematically organized disease management program that employ multi-faceted interventions incorporating various specific measures to maximize both clinician (as investigator) adherence with treatment guideline and patient adherence with treatment.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Diabetes Mellitus Hyperlipidemia||Behavioral: No Active Intervention. Behavioral: Community Based Multiple Risk Factor Intervention Strategies||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||770 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community Based Multiple Risk Factors Intervention Strategy to Prevent Cardiovascular and Chronic Kidney Diseases [CORFIS]|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||January 2009|
Conventional Patient Management on Hypertension, Diabetes Mellitus and Hyperlipidaemia by Malaysian GP
Behavioral: No Active Intervention.
Conventional Chronic Disease Management in Malaysia Primary Care
Other Name: Control
Active Comparator: CORFIS Arm
Community based Multiple Risk Factor Intervention Strategies
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.
Other Name: CORFIS
- Proportion of patients able to reach treatment goals. [ Time Frame: 6 months follow up ]
- The safety of the drug product used in the study will be assessed using the procedure for adverse drug reactions reporting for marketed medicinal products regulated by the Malaysian regulatory authority. [ Time Frame: 6 months follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490672
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|Principal Investigator:||Teck Onn Lim, FRCP||Ministry of Health, Malaysia|
|Study Chair:||Zaki M Mohd Zaher, FRCP||International Medical University Malaysia|