Community Based Multiple Risk Factors Intervention Strategy
- Conditions
- Diabetes MellitusHypertensionHyperlipidemia
- Interventions
- Behavioral: No Active Intervention.Behavioral: Community Based Multiple Risk Factor Intervention Strategies
- Registration Number
- NCT00490672
- Lead Sponsor
- Ministry of Health, Malaysia
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 770
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm No Active Intervention. Conventional Patient Management on Hypertension, Diabetes Mellitus and Hyperlipidaemia by Malaysian GP CORFIS Arm Community Based Multiple Risk Factor Intervention Strategies Community based Multiple Risk Factor Intervention Strategies
- Primary Outcome Measures
Name Time Method Proportion of patients able to reach treatment goals. 6 months follow up
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (77)
Klinik Vicky
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Kumpulan Medi-Systems Sdn Bhd
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Dan Surgeri Putra
🇲🇾Ampang, Selangor, Malaysia
Klinik Idzham Sdn Bhd
🇲🇾Ampang, Selangor, Malaysia
Poliklinik Gomez 24 Jam
🇲🇾Ampang, Selangor, Malaysia
Klinik Tan & Mano
🇲🇾Ampang, Selangor, Malaysia
Poliklinik Penawar
🇲🇾Ampang, Selangor, Malaysia
Klinik Hayati (Poliklinik & Surgeri)
🇲🇾Batu Caves, Selangor, Malaysia
Lok Dispensary
🇲🇾Klang, Selangor, Malaysia
Klinik Yuen
🇲🇾Klang, Selangor, Malaysia
Klinik Wan Elina
🇲🇾Klang, Selangor, Malaysia
Klinik Ng & Lim
🇲🇾Klang, Selangor, Malaysia
Poliklinik Hari
🇲🇾Klang, Selangor, Malaysia
Klinik Khaty Am
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Primecare
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Alam Medic
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Rakan Medik
🇲🇾Petaling Jaya, Selangor, Malaysia
Poliklinik Rakyat
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Dr Shamsuddin
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Ready Care
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Raya
🇲🇾Puchong, Selangor, Malaysia
Klinik Hafiz
🇲🇾Puchong, Selangor, Malaysia
Klinik Bandaran Sdn Bhd
🇲🇾Shah Alam, Selangor, Malaysia
Poliklinik Sri Muda
🇲🇾Shah Alam, Selangor, Malaysia
Klinik Leong
🇲🇾Puchong, Selangor, Malaysia
Klinik Reddy
🇲🇾Puchong, Selangor, Malaysia
Klinik Sarrimadh
🇲🇾Seri Kembangan, Selangor, Malaysia
Poliklinik Roshan
🇲🇾Subang Jaya, Selangor, Malaysia
MAS Medical Centre
🇲🇾Subang, Selangor, Malaysia
Klinik Putera (Poliklinik Bistari)
🇲🇾Ampang, Selangor, Malaysia
Poliklinik Kumpulan City
🇲🇾Batu Caves, Selangor, Malaysia
Klinik Kelana Puteri
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Kok dan Wendy
🇲🇾Subang Jaya, Selangor, Malaysia
Klinik Bandaran
🇲🇾Klang, Selangor, Malaysia
Klinik Stella Maris Sdn Bhd
🇲🇾Klang, Selangor, Malaysia
Klinik Utama
🇲🇾Klang, Selangor, Malaysia
Horeb Sdn Bhd
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Tenaga Baru
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Sharani
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Keluarga Siva Lim
🇲🇾Klang, Selangor, Malaysia
Klinik Chew
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Reddy Setapak
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Medik (Dr Amir & Rakan-Rakan)
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Sharon
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Dr Khalil
🇲🇾Kuala Lumpur, Federal Territoy, Malaysia
Klinik Ehsan
🇲🇾Mentakab, Pahang, Malaysia
Poliklinik Idaman
🇲🇾Batu Caves, Selangor, Malaysia
Klinik Mediviron
🇲🇾Ampang, Selangor, Malaysia
Klinik Tan & Mano Sdn Bhd
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Shafi
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Poliklinik Kepong Baru
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Care Poliklinik & Surgeri
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Prime Care
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Poliklinik Medics
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Famili TTDI
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Victor Medical Practice
🇲🇾Subang Jaya, Selangor, Malaysia
Klinik Dr Nur Ainita
🇲🇾Subang Jaya, Selangor, Malaysia
Klinik Kaulsay
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Unimed Plaza Damansara
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Poliklinik Kumpulan City (Plaza Damansara)
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Keluarga
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Poliklinik Salak Selatan
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Medi Pesona
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
PoliKlinik Bangsar
🇲🇾Kuala Lumpur, Federal Territory, Malaysia
Klinik Nathan Dan Rakan-Rakan
🇲🇾Batu Caves, Selangor, Malaysia
Klinik Keluarga Azian & Elina
🇲🇾Klang, Selangor, Malaysia
Klinik Kelang
🇲🇾Shah Alam, Selangor, Malaysia
Klinik Lim
🇲🇾Klang, Selangor, Malaysia
Poliklinik Shaik (Sunway) Sdn Bhd
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Petaling Jaya
🇲🇾Petaling Jaya, Selangor, Malaysia
Poliklinik Hidayah
🇲🇾Petaling Jaya, Selangor, Malaysia
Klinik Ng Singh & Rakan-Rakan
🇲🇾Rawang, Selangor, Malaysia
Klinik Dan Surgeri Alpha Medic
🇲🇾Shah Alam, 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