Community Based Multiple Risk Factors Intervention Strategy (CORFIS)

This study has been completed.
Sponsor:
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT00490672
First received: June 21, 2007
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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 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]

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • Proportion of patients able to reach treatment goals. [ Time Frame: 6 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00490672

  Show 78 Study Locations
Sponsors and Collaborators
Ministry of Health, Malaysia
Investigators
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:
Hypertension
Diabetes Mellitus
Hyperlipidemias
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 22, 2014