Community Based Multiple Risk Factors Intervention Strategy (CORFIS)

April 6, 2015 updated by: Ministry of Health, Malaysia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

770

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Federal Territory
      • Kuala Lumpur, Federal Territory, Malaysia, 50250
        • Horeb Sdn Bhd
      • Kuala Lumpur, Federal Territory, Malaysia, 50450
        • Klinik Tan & Mano Sdn Bhd
      • Kuala Lumpur, Federal Territory, Malaysia, 50490
        • Klinik Kaulsay
      • Kuala Lumpur, Federal Territory, Malaysia, 50490
        • Klinik Unimed Plaza Damansara
      • Kuala Lumpur, Federal Territory, Malaysia, 50490
        • Poliklinik Kumpulan City (Plaza Damansara)
      • Kuala Lumpur, Federal Territory, Malaysia, 52000
        • Klinik Shafi
      • Kuala Lumpur, Federal Territory, Malaysia, 52100
        • Poliklinik Kepong Baru
      • Kuala Lumpur, Federal Territory, Malaysia, 53000
        • Klinik Chew
      • Kuala Lumpur, Federal Territory, Malaysia, 53000
        • Klinik Reddy Setapak
      • Kuala Lumpur, Federal Territory, Malaysia, 53100
        • Klinik Medik (Dr Amir & Rakan-Rakan)
      • Kuala Lumpur, Federal Territory, Malaysia, 53300
        • Klinik Keluarga
      • Kuala Lumpur, Federal Territory, Malaysia, 53300
        • Klinik Vicky
      • Kuala Lumpur, Federal Territory, Malaysia, 56100
        • Klinik Care Poliklinik & Surgeri
      • Kuala Lumpur, Federal Territory, Malaysia, 56100
        • Klinik Tenaga Baru
      • Kuala Lumpur, Federal Territory, Malaysia, 56100
        • Kumpulan Medi-Systems Sdn Bhd
      • Kuala Lumpur, Federal Territory, Malaysia, 57100
        • Poliklinik Salak Selatan
      • Kuala Lumpur, Federal Territory, Malaysia, 58200
        • Klinik Sharon
      • Kuala Lumpur, Federal Territory, Malaysia, 59000
        • Klinik Medi Pesona
      • Kuala Lumpur, Federal Territory, Malaysia, 59000
        • Klinik Sharani
      • Kuala Lumpur, Federal Territory, Malaysia, 59100
        • Klinik Prime Care
      • Kuala Lumpur, Federal Territory, Malaysia, 59100
        • PoliKlinik Bangsar
      • Kuala Lumpur, Federal Territory, Malaysia, 59200
        • Poliklinik Medics
      • Kuala Lumpur, Federal Territory, Malaysia, 60000
        • Klinik Famili TTDI
    • Federal Territoy
      • Kuala Lumpur, Federal Territoy, Malaysia, 52100
        • Klinik Dr Khalil
    • Pahang
      • Mentakab, Pahang, Malaysia, 28400
        • Klinik Ehsan
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Klinik Dan Surgeri Putra
      • Ampang, Selangor, Malaysia, 68000
        • Klinik Idzham Sdn Bhd
      • Ampang, Selangor, Malaysia, 68000
        • Klinik Mediviron
      • Ampang, Selangor, Malaysia, 68000
        • Klinik Putera (Poliklinik Bistari)
      • Ampang, Selangor, Malaysia, 68000
        • Klinik Tan & Mano
      • Ampang, Selangor, Malaysia, 68000
        • Poliklinik Gomez 24 Jam
      • Ampang, Selangor, Malaysia, 68000
        • Poliklinik Penawar
      • Batu Caves, Selangor, Malaysia, 68100
        • Klinik Hayati (Poliklinik & Surgeri)
      • Batu Caves, Selangor, Malaysia, 68100
        • Klinik Nathan Dan Rakan-Rakan
      • Batu Caves, Selangor, Malaysia, 68100
        • Poliklinik Idaman
      • Batu Caves, Selangor, Malaysia, 68100
        • Poliklinik Kumpulan City
      • Klang, Selangor, Malaysia, 41000
        • Klinik Keluarga Azian & Elina
      • Klang, Selangor, Malaysia, 41300
        • Klinik Keluarga Siva Lim
      • Klang, Selangor, Malaysia, 41300
        • Lok Dispensary
      • Klang, Selangor, Malaysia, 41400
        • Klinik Bandaran
      • Klang, Selangor, Malaysia, 41400
        • Klinik Kelang
      • Klang, Selangor, Malaysia, 41400
        • Klinik Lim
      • Klang, Selangor, Malaysia, 41400
        • Klinik Yuen
      • Klang, Selangor, Malaysia, 42000
        • Klinik Stella Maris Sdn Bhd
      • Klang, Selangor, Malaysia, 42000
        • Klinik Utama
      • Klang, Selangor, Malaysia, 42000
        • Klinik Wan Elina
      • Klang, Selangor, Malaysia, 42000
        • Poliklinik Hari
      • Klang, Selangor, Malaysia, 42100
        • Klinik Ng & Lim
      • Petaling Jaya, Selangor, Malaysia, 46000
        • Klinik Khaty Am
      • Petaling Jaya, Selangor, Malaysia, 46150
        • Poliklinik Shaik (Sunway) Sdn Bhd
      • Petaling Jaya, Selangor, Malaysia, 46350
        • Klinik Primecare
      • Petaling Jaya, Selangor, Malaysia, 47300
        • Klinik Petaling Jaya
      • Petaling Jaya, Selangor, Malaysia, 47301
        • Klinik Alam Medic
      • Petaling Jaya, Selangor, Malaysia, 47301
        • Klinik Rakan Medik
      • Petaling Jaya, Selangor, Malaysia, 47301
        • Poliklinik Rakyat
      • Petaling Jaya, Selangor, Malaysia, 47601
        • Klinik Kelana Puteri
      • Petaling Jaya, Selangor, Malaysia, 47800
        • Klinik Ready Care
      • Petaling Jaya, Selangor, Malaysia, 47810
        • Poliklinik Hidayah
      • Petaling Jaya, Selangor, Malaysia, 47830
        • Klinik Dr Shamsuddin
      • Puchong, Selangor, Malaysia, 47100
        • Klinik Hafiz
      • Puchong, Selangor, Malaysia, 47100
        • Klinik Leong
      • Puchong, Selangor, Malaysia, 47100
        • Klinik Raya
      • Puchong, Selangor, Malaysia, 58200
        • Klinik Reddy
      • Rawang, Selangor, Malaysia, 48000
        • Klinik Ng Singh & Rakan-Rakan
      • Seri Kembangan, Selangor, Malaysia, 43300
        • Klinik Sarrimadh
      • Shah Alam, Selangor, Malaysia, 40000
        • Klinik Bandaran Sdn Bhd
      • Shah Alam, Selangor, Malaysia, 40000
        • Klinik Kelang
      • Shah Alam, Selangor, Malaysia, 40400
        • Poliklinik Sri Muda
      • Shah Alam, Selangor, Malaysia, 42450
        • Klinik Dan Surgeri Alpha Medic
      • Subang, Selangor, Malaysia, 47200
        • MAS Medical Centre
      • Subang Jaya, Selangor, Malaysia, 47500
        • Klinik Medic Bestari
      • Subang Jaya, Selangor, Malaysia, 47600
        • Klinik Medifom
      • Subang Jaya, Selangor, Malaysia, 47600
        • Victor Medical Practice
      • Subang Jaya, Selangor, Malaysia, 47610
        • Klinik Medijaya
      • Subang Jaya, Selangor, Malaysia, 47620
        • Klinik Dr Nur Ainita
      • Subang Jaya, Selangor, Malaysia, 47620
        • Klinik Taipan
      • Subang Jaya, Selangor, Malaysia, 47620
        • Poliklinik Roshan
      • Subang Jaya, Selangor, Malaysia, 47630
        • Klinik Kok dan Wendy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • 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 Names:
  • CORFIS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 6 months follow up
6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 21, 2007

First Submitted That Met QC Criteria

June 21, 2007

First Posted (Estimate)

June 25, 2007

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT07-02
  • NMRR ID Number: 447

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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