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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

June 21, 2007
April 22, 2010
August 2007
December 2008   (final data collection date for primary outcome measure)
Proportion of patients able to reach treatment goals. [ Time Frame: 6 months follow up ] [ Designated as safety issue: No ]
Proportion of patients able to reach treatment goals. [ Time Frame: 6 months follow up ]
Complete list of historical versions of study NCT00490672 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Community Based Multiple Risk Factors Intervention Strategy
Community Based Multiple Risk Factors Intervention Strategy to Prevent Cardiovascular and Chronic Kidney Diseases [CORFIS]

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Diabetes Mellitus
  • Hyperlipidemia
  • Behavioral: No Active Intervention.
    Conventional Chronic Disease Management in Malaysia Primary Care
    Other Name: Control
  • 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
  • No Intervention: Control Arm
    Conventional Patient Management on Hypertension, Diabetes Mellitus and Hyperlipidaemia by Malaysian GP
    Intervention: Behavioral: No Active Intervention.
  • Active Comparator: CORFIS Arm
    Community based Multiple Risk Factor Intervention Strategies
    Intervention: Behavioral: Community Based Multiple Risk Factor Intervention Strategies
Chua SS, Kok LC, Yusof FA, Tang GH, Lee SW, Efendie B, Paraidathathu T. Pharmaceutical care issues identified by pharmacists in patients with diabetes, hypertension or hyperlipidaemia in primary care settings. BMC Health Serv Res. 2012 Nov 12;12:388. doi: 10.1186/1472-6963-12-388.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
770
January 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT00490672
CT07-02, NMRR ID Number: 447
Yes
Dr. Lim Teck Onn, Clinical Research Centre, Hospital Kuala Lumpur
Ministry of Health, Malaysia
Not Provided
Principal Investigator: Teck Onn Lim, FRCP Ministry of Health, Malaysia
Study Chair: Zaki M Mohd Zaher, FRCP International Medical University Malaysia
Ministry of Health, Malaysia
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP