Community Based Multiple Risk Factors Intervention Strategy (CORFIS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Hypertension Diabetes Mellitus Hyperlipidemia |
Behavioral: No Active Intervention. Behavioral: Community Based Multiple Risk Factor Intervention Strategies |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Community Based Multiple Risk Factors Intervention Strategy to Prevent Cardiovascular and Chronic Kidney Diseases [CORFIS] |
- Proportion of patients able to reach treatment goals. [ Time Frame: 6 months follow up ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 770 |
| Study Start Date: | August 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Show 78 Study Locations| Principal Investigator: | Teck Onn Lim, FRCP | Ministry of Health, Malaysia |
| Study Chair: | Zaki M Mohd Zaher, FRCP | International Medical University Malaysia |
More Information
No publications provided by Ministry of Health, Malaysia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Lim Teck Onn, Clinical Research Centre, Hospital Kuala Lumpur |
| ClinicalTrials.gov Identifier: | NCT00490672 History of Changes |
| Other Study ID Numbers: | CT07-02, NMRR ID Number: 447 |
| Study First Received: | June 21, 2007 |
| Last Updated: | April 22, 2010 |
| Health Authority: | Malaysia: Ministry of Health |
Keywords provided by Ministry of Health, Malaysia:
|
Hypertension Diabetes Mellitus Hyperlipidaemia |
Primary Care Community Care Multiple Risk Factors Interventional Strategies |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hyperlipidemias Hypertension Renal Insufficiency, Chronic Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Dyslipidemias Lipid Metabolism Disorders Vascular Diseases Cardiovascular Diseases Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013