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NCT00490672 Clinical Trial

Community Based Multiple Risk Factors Intervention Strategy

Hypertension Clinical Trial

— CORFIS  

Official title:
Community Based Multiple Risk Factors Intervention Strategy to Prevent Cardiovascular and Chronic Kidney Diseases [CORFIS]

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00490672
Other study ID # CT07-02
Secondary ID NMRR ID Number:
Status Completed
Phase Phase 4
First received June 21, 2007
Last updated April 6, 2015
Start date August 2007
Est. completion date January 2009

Study information
Verified date April 2010
Source Ministry of Health, Malaysia
Contact n/a
Is FDA regulated No
Health authority Malaysia: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 770
Est. completion date January 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• No Active Intervention.
Conventional Chronic Disease Management in Malaysia Primary Care
• 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.

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

Sponsors (1)
Lead Sponsor Collaborator
Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients able to reach treatment goals. 6 months follow up No
Secondary 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. 6 months follow up Yes
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