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Community Based Multiple Risk Factors Intervention Strategy (CORFIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490672
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : April 7, 2015
Information provided by:
Ministry of Health, Malaysia

Brief Summary:

Randomized controlled trial of CORFIS Programme.

The study objectives are as follows:

  1. 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.
  2. 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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Control Arm
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

Primary Outcome Measures :
  1. Proportion of patients able to reach treatment goals. [ Time Frame: 6 months follow up ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. 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
  2. Patients age 18 years and above.
  3. Written informed consent obtained from patients.

Exclusion criteria:

  1. Pregnant or nursing women.
  2. History of unstable angina, acute myocardial infarction or coronary revascularisation procedure in the preceding 6 months.
  3. Clinically significant valvular heart disease.
  4. Overt heart failure or history of heart failure in the preceding 6 months
  5. Stroke in the preceding 6 months.
  6. Serum creatinine more than 150umol/l in the preceding 6 months.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00490672

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Sponsors and Collaborators
Ministry of Health, Malaysia
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Lim Teck Onn, Clinical Research Centre, Hospital Kuala Lumpur Identifier: NCT00490672    
Other Study ID Numbers: CT07-02
NMRR ID Number: 447
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2010
Keywords provided by Ministry of Health, Malaysia:
Diabetes Mellitus
Primary Care
Community Care
Multiple Risk Factors Interventional Strategies
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders