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Community Based Multiple Risk Factors Intervention Strategy (CORFIS)

Primary Purpose

Hypertension, Diabetes Mellitus, Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
No Active Intervention.
Community Based Multiple Risk Factor Intervention Strategies
Sponsored by
Ministry of Health, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Diabetes Mellitus, Hyperlipidaemia, Primary Care, Community Care, Multiple Risk Factors Interventional Strategies

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Horeb Sdn Bhd
  • Klinik Tan & Mano Sdn Bhd
  • Klinik Kaulsay
  • Klinik Unimed Plaza Damansara
  • Poliklinik Kumpulan City (Plaza Damansara)
  • Klinik Shafi
  • Poliklinik Kepong Baru
  • Klinik Chew
  • Klinik Reddy Setapak
  • Klinik Medik (Dr Amir & Rakan-Rakan)
  • Klinik Keluarga
  • Klinik Vicky
  • Klinik Care Poliklinik & Surgeri
  • Klinik Tenaga Baru
  • Kumpulan Medi-Systems Sdn Bhd
  • Poliklinik Salak Selatan
  • Klinik Sharon
  • Klinik Medi Pesona
  • Klinik Sharani
  • Klinik Prime Care
  • PoliKlinik Bangsar
  • Poliklinik Medics
  • Klinik Famili TTDI
  • Klinik Dr Khalil
  • Klinik Ehsan
  • Klinik Dan Surgeri Putra
  • Klinik Idzham Sdn Bhd
  • Klinik Mediviron
  • Klinik Putera (Poliklinik Bistari)
  • Klinik Tan & Mano
  • Poliklinik Gomez 24 Jam
  • Poliklinik Penawar
  • Klinik Hayati (Poliklinik & Surgeri)
  • Klinik Nathan Dan Rakan-Rakan
  • Poliklinik Idaman
  • Poliklinik Kumpulan City
  • Klinik Keluarga Azian & Elina
  • Klinik Keluarga Siva Lim
  • Lok Dispensary
  • Klinik Bandaran
  • Klinik Kelang
  • Klinik Lim
  • Klinik Yuen
  • Klinik Stella Maris Sdn Bhd
  • Klinik Utama
  • Klinik Wan Elina
  • Poliklinik Hari
  • Klinik Ng & Lim
  • Klinik Khaty Am
  • Poliklinik Shaik (Sunway) Sdn Bhd
  • Klinik Primecare
  • Klinik Petaling Jaya
  • Klinik Alam Medic
  • Klinik Rakan Medik
  • Poliklinik Rakyat
  • Klinik Kelana Puteri
  • Klinik Ready Care
  • Poliklinik Hidayah
  • Klinik Dr Shamsuddin
  • Klinik Hafiz
  • Klinik Leong
  • Klinik Raya
  • Klinik Reddy
  • Klinik Ng Singh & Rakan-Rakan
  • Klinik Sarrimadh
  • Klinik Bandaran Sdn Bhd
  • Klinik Kelang
  • Poliklinik Sri Muda
  • Klinik Dan Surgeri Alpha Medic
  • Klinik Medic Bestari
  • Klinik Medifom
  • Victor Medical Practice
  • Klinik Medijaya
  • Klinik Dr Nur Ainita
  • Klinik Taipan
  • Poliklinik Roshan
  • Klinik Kok dan Wendy
  • MAS Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control Arm

CORFIS Arm

Arm Description

Conventional Patient Management on Hypertension, Diabetes Mellitus and Hyperlipidaemia by Malaysian GP

Community based Multiple Risk Factor Intervention Strategies

Outcomes

Primary Outcome Measures

Proportion of patients able to reach treatment goals.

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.

Full Information

First Posted
June 21, 2007
Last Updated
April 6, 2015
Sponsor
Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT00490672
Brief Title
Community Based Multiple Risk Factors Intervention Strategy
Acronym
CORFIS
Official Title
Community Based Multiple Risk Factors Intervention Strategy to Prevent Cardiovascular and Chronic Kidney Diseases [CORFIS]
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Malaysia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Hyperlipidemia
Keywords
Hypertension, Diabetes Mellitus, Hyperlipidaemia, Primary Care, Community Care, Multiple Risk Factors Interventional Strategies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
770 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Other
Arm Description
Conventional Patient Management on Hypertension, Diabetes Mellitus and Hyperlipidaemia by Malaysian GP
Arm Title
CORFIS Arm
Arm Type
Active Comparator
Arm Description
Community based Multiple Risk Factor Intervention Strategies
Intervention Type
Behavioral
Intervention Name(s)
No Active Intervention.
Other Intervention Name(s)
Control
Intervention Description
Conventional Chronic Disease Management in Malaysia Primary Care
Intervention Type
Behavioral
Intervention Name(s)
Community Based Multiple Risk Factor Intervention Strategies
Other Intervention Name(s)
CORFIS
Intervention Description
Multi-faceted Intervention in Chronic Diseases Management i.e. Hypertension, Diabetes Mellitus, Hyperlipidaemia involving Primary Health Care Physicians, Nurse Educators, Dieticians and Pharmacists.
Primary Outcome Measure Information:
Title
Proportion of patients able to reach treatment goals.
Time Frame
6 months follow up
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teck Onn Lim, FRCP
Organizational Affiliation
Ministry of Health, Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zaki M Mohd Zaher, FRCP
Organizational Affiliation
International Medical University Malaysia
Official's Role
Study Chair
Facility Information:
Facility Name
Horeb Sdn Bhd
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
50250
Country
Malaysia
Facility Name
Klinik Tan & Mano Sdn Bhd
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
50450
Country
Malaysia
Facility Name
Klinik Kaulsay
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
50490
Country
Malaysia
Facility Name
Klinik Unimed Plaza Damansara
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
50490
Country
Malaysia
Facility Name
Poliklinik Kumpulan City (Plaza Damansara)
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
50490
Country
Malaysia
Facility Name
Klinik Shafi
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
52000
Country
Malaysia
Facility Name
Poliklinik Kepong Baru
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
52100
Country
Malaysia
Facility Name
Klinik Chew
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
53000
Country
Malaysia
Facility Name
Klinik Reddy Setapak
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
53000
Country
Malaysia
Facility Name
Klinik Medik (Dr Amir & Rakan-Rakan)
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
53100
Country
Malaysia
Facility Name
Klinik Keluarga
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
53300
Country
Malaysia
Facility Name
Klinik Vicky
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
53300
Country
Malaysia
Facility Name
Klinik Care Poliklinik & Surgeri
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
56100
Country
Malaysia
Facility Name
Klinik Tenaga Baru
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
56100
Country
Malaysia
Facility Name
Kumpulan Medi-Systems Sdn Bhd
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
56100
Country
Malaysia
Facility Name
Poliklinik Salak Selatan
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
57100
Country
Malaysia
Facility Name
Klinik Sharon
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
58200
Country
Malaysia
Facility Name
Klinik Medi Pesona
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
59000
Country
Malaysia
Facility Name
Klinik Sharani
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
59000
Country
Malaysia
Facility Name
Klinik Prime Care
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
PoliKlinik Bangsar
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Poliklinik Medics
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
59200
Country
Malaysia
Facility Name
Klinik Famili TTDI
City
Kuala Lumpur
State/Province
Federal Territory
ZIP/Postal Code
60000
Country
Malaysia
Facility Name
Klinik Dr Khalil
City
Kuala Lumpur
State/Province
Federal Territoy
ZIP/Postal Code
52100
Country
Malaysia
Facility Name
Klinik Ehsan
City
Mentakab
State/Province
Pahang
ZIP/Postal Code
28400
Country
Malaysia
Facility Name
Klinik Dan Surgeri Putra
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Klinik Idzham Sdn Bhd
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Klinik Mediviron
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Klinik Putera (Poliklinik Bistari)
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Klinik Tan & Mano
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Poliklinik Gomez 24 Jam
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Poliklinik Penawar
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Facility Name
Klinik Hayati (Poliklinik & Surgeri)
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Klinik Nathan Dan Rakan-Rakan
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Poliklinik Idaman
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Poliklinik Kumpulan City
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Klinik Keluarga Azian & Elina
City
Klang
State/Province
Selangor
ZIP/Postal Code
41000
Country
Malaysia
Facility Name
Klinik Keluarga Siva Lim
City
Klang
State/Province
Selangor
ZIP/Postal Code
41300
Country
Malaysia
Facility Name
Lok Dispensary
City
Klang
State/Province
Selangor
ZIP/Postal Code
41300
Country
Malaysia
Facility Name
Klinik Bandaran
City
Klang
State/Province
Selangor
ZIP/Postal Code
41400
Country
Malaysia
Facility Name
Klinik Kelang
City
Klang
State/Province
Selangor
ZIP/Postal Code
41400
Country
Malaysia
Facility Name
Klinik Lim
City
Klang
State/Province
Selangor
ZIP/Postal Code
41400
Country
Malaysia
Facility Name
Klinik Yuen
City
Klang
State/Province
Selangor
ZIP/Postal Code
41400
Country
Malaysia
Facility Name
Klinik Stella Maris Sdn Bhd
City
Klang
State/Province
Selangor
ZIP/Postal Code
42000
Country
Malaysia
Facility Name
Klinik Utama
City
Klang
State/Province
Selangor
ZIP/Postal Code
42000
Country
Malaysia
Facility Name
Klinik Wan Elina
City
Klang
State/Province
Selangor
ZIP/Postal Code
42000
Country
Malaysia
Facility Name
Poliklinik Hari
City
Klang
State/Province
Selangor
ZIP/Postal Code
42000
Country
Malaysia
Facility Name
Klinik Ng & Lim
City
Klang
State/Province
Selangor
ZIP/Postal Code
42100
Country
Malaysia
Facility Name
Klinik Khaty Am
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
46000
Country
Malaysia
Facility Name
Poliklinik Shaik (Sunway) Sdn Bhd
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
46150
Country
Malaysia
Facility Name
Klinik Primecare
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
46350
Country
Malaysia
Facility Name
Klinik Petaling Jaya
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47300
Country
Malaysia
Facility Name
Klinik Alam Medic
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47301
Country
Malaysia
Facility Name
Klinik Rakan Medik
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47301
Country
Malaysia
Facility Name
Poliklinik Rakyat
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47301
Country
Malaysia
Facility Name
Klinik Kelana Puteri
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47601
Country
Malaysia
Facility Name
Klinik Ready Care
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47800
Country
Malaysia
Facility Name
Poliklinik Hidayah
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47810
Country
Malaysia
Facility Name
Klinik Dr Shamsuddin
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
47830
Country
Malaysia
Facility Name
Klinik Hafiz
City
Puchong
State/Province
Selangor
ZIP/Postal Code
47100
Country
Malaysia
Facility Name
Klinik Leong
City
Puchong
State/Province
Selangor
ZIP/Postal Code
47100
Country
Malaysia
Facility Name
Klinik Raya
City
Puchong
State/Province
Selangor
ZIP/Postal Code
47100
Country
Malaysia
Facility Name
Klinik Reddy
City
Puchong
State/Province
Selangor
ZIP/Postal Code
58200
Country
Malaysia
Facility Name
Klinik Ng Singh & Rakan-Rakan
City
Rawang
State/Province
Selangor
ZIP/Postal Code
48000
Country
Malaysia
Facility Name
Klinik Sarrimadh
City
Seri Kembangan
State/Province
Selangor
ZIP/Postal Code
43300
Country
Malaysia
Facility Name
Klinik Bandaran Sdn Bhd
City
Shah Alam
State/Province
Selangor
ZIP/Postal Code
40000
Country
Malaysia
Facility Name
Klinik Kelang
City
Shah Alam
State/Province
Selangor
ZIP/Postal Code
40000
Country
Malaysia
Facility Name
Poliklinik Sri Muda
City
Shah Alam
State/Province
Selangor
ZIP/Postal Code
40400
Country
Malaysia
Facility Name
Klinik Dan Surgeri Alpha Medic
City
Shah Alam
State/Province
Selangor
ZIP/Postal Code
42450
Country
Malaysia
Facility Name
Klinik Medic Bestari
City
Subang Jaya
State/Province
Selangor
ZIP/Postal Code
47500
Country
Malaysia
Facility Name
Klinik Medifom
City
Subang Jaya
State/Province
Selangor
ZIP/Postal Code
47600
Country
Malaysia
Facility Name
Victor Medical Practice
City
Subang Jaya
State/Province
Selangor
ZIP/Postal Code
47600
Country
Malaysia
Facility Name
Klinik Medijaya
City
Subang Jaya
State/Province
Selangor
ZIP/Postal Code
47610
Country
Malaysia
Facility Name
Klinik Dr Nur Ainita
City
Subang Jaya
State/Province
Selangor
ZIP/Postal Code
47620
Country
Malaysia
Facility Name
Klinik Taipan
City
Subang Jaya
State/Province
Selangor
ZIP/Postal Code
47620
Country
Malaysia
Facility Name
Poliklinik Roshan
City
Subang Jaya
State/Province
Selangor
ZIP/Postal Code
47620
Country
Malaysia
Facility Name
Klinik Kok dan Wendy
City
Subang Jaya
State/Province
Selangor
ZIP/Postal Code
47630
Country
Malaysia
Facility Name
MAS Medical Centre
City
Subang
State/Province
Selangor
ZIP/Postal Code
47200
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23145922
Citation
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.
Results Reference
derived

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Community Based Multiple Risk Factors Intervention Strategy

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