Community Based Multiple Risk Factors Intervention Strategy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community Based Multiple Risk Factors Intervention Strategy to Prevent Cardiovascular and Chronic Kidney Diseases [CORFIS]

Conditions
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Hypertension, Diabetes Mellitus, Hyperlipidemia

Intervention / Treatment
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* Behavioral: No Active Intervention.
* Behavioral: Community Based Multiple Risk Factor Intervention Strategies


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients diagnosed by participating GP to have Hypertension and/or Diabetes mellitus and/or Hyperlipidaemias, and currently on drug treatment for one or more of these conditions Patients age 18 years and above. Written informed consent obtained from patients. Exclusion criteria: Pregnant or nursing women. History of unstable angina, acute myocardial infarction or coronary revascularisation procedure in the preceding 6 months. Clinically significant valvular heart disease. Overt heart failure or history of heart failure in the preceding 6 months Stroke in the preceding 6 months. Serum creatinine more than 150umol/l in the preceding 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Arm<br>Conventional Patient Management on Hypertension, Diabetes Mellitus and Hyperlipidaemia by Malaysian GP | Behavioral: No Active Intervention.<br>* Conventional Chronic Disease Management in Malaysia Primary Care<br>* Other names: Control;|
| Active Comparator: CORFIS Arm<br>Community based Multiple Risk Factor Intervention Strategies | Behavioral: Community Based Multiple Risk Factor Intervention Strategies<br>* Multi-faceted Intervention in Chronic Diseases Management i.e. Hypertension, Diabetes Mellitus, Hyperlipidaemia involving Primary Health Care Physicians, Nurse Educators, Dieticians and Pharmacists.<br>* Other names: CORFIS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients able to reach treatment goals. |  | 6 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Diabetes Mellitus, Hyperlipidaemia, Primary Care, Community Care, Multiple Risk Factors Interventional Strategies