Clinical trial NCT00490672: Community Based Multiple Risk Factors Intervention Strategy
Official title: Community Based Multiple Risk Factors Intervention Strategy to Prevent Cardiovascular and Chronic Kidney Diseases [CORFIS]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Diabetes Mellitus
Hyperlipidemia
Keywords: Hypertension
Diabetes Mellitus
Hyperlipidaemia
Primary Care
Community Care
Multiple Risk Factors Interventional Strategies
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
First posted: 2007-06-25
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients able to reach treatment goals.
timeFrame: 6 months follow up
Secondary outcomes:
measure: 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.
timeFrame: 6 months follow up
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Horeb Sdn Bhd
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Tan & Mano Sdn Bhd
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Kaulsay
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Unimed Plaza Damansara
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Poliklinik Kumpulan City (Plaza Damansara)
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Shafi
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Poliklinik Kepong Baru
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Chew
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Reddy Setapak
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Medik (Dr Amir & Rakan-Rakan)
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Keluarga
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Vicky
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Care Poliklinik & Surgeri
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Tenaga Baru
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Kumpulan Medi-Systems Sdn Bhd
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Poliklinik Salak Selatan
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Sharon
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Medi Pesona
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Sharani
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Prime Care
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: PoliKlinik Bangsar
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Poliklinik Medics
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Famili TTDI
state: Federal Territory
city: Kuala Lumpur
country: Malaysia
facility: Klinik Dr Khalil
state: Federal Territoy
city: Mentakab
country: Malaysia
facility: Klinik Ehsan
state: Pahang
city: Ampang
country: Malaysia
facility: Klinik Dan Surgeri Putra
state: Selangor
city: Ampang
country: Malaysia
facility: Klinik Idzham Sdn Bhd
state: Selangor
city: Ampang
country: Malaysia
facility: Klinik Mediviron
state: Selangor
city: Ampang
country: Malaysia
facility: Klinik Putera (Poliklinik Bistari)
state: Selangor
city: Ampang
country: Malaysia
facility: Klinik Tan & Mano
state: Selangor
city: Ampang
country: Malaysia
facility: Poliklinik Gomez 24 Jam
state: Selangor
city: Ampang
country: Malaysia
facility: Poliklinik Penawar
state: Selangor
city: Batu Caves
country: Malaysia
facility: Klinik Hayati (Poliklinik & Surgeri)
state: Selangor
city: Batu Caves
country: Malaysia
facility: Klinik Nathan Dan Rakan-Rakan
state: Selangor
city: Batu Caves
country: Malaysia
facility: Poliklinik Idaman
state: Selangor
city: Batu Caves
country: Malaysia
facility: Poliklinik Kumpulan City
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Keluarga Azian & Elina
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Keluarga Siva Lim
state: Selangor
city: Klang
country: Malaysia
facility: Lok Dispensary
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Bandaran
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Kelang
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Lim
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Yuen
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Stella Maris Sdn Bhd
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Utama
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Wan Elina
state: Selangor
city: Klang
country: Malaysia
facility: Poliklinik Hari
state: Selangor
city: Klang
country: Malaysia
facility: Klinik Ng & Lim
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Khaty Am
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Poliklinik Shaik (Sunway) Sdn Bhd
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Primecare
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Petaling Jaya
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Alam Medic
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Rakan Medik
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Poliklinik Rakyat
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Kelana Puteri
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Ready Care
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Poliklinik Hidayah
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Klinik Dr Shamsuddin
state: Selangor
city: Puchong
country: Malaysia
facility: Klinik Hafiz
state: Selangor
city: Puchong
country: Malaysia
facility: Klinik Leong
state: Selangor
city: Puchong
country: Malaysia
facility: Klinik Raya
state: Selangor
city: Puchong
country: Malaysia
facility: Klinik Reddy
state: Selangor
city: Rawang
country: Malaysia
facility: Klinik Ng Singh & Rakan-Rakan
state: Selangor
city: Seri Kembangan
country: Malaysia
facility: Klinik Sarrimadh
state: Selangor
city: Shah Alam
country: Malaysia
facility: Klinik Bandaran Sdn Bhd
state: Selangor
city: Shah Alam
country: Malaysia
facility: Klinik Kelang
state: Selangor
city: Shah Alam
country: Malaysia
facility: Poliklinik Sri Muda
state: Selangor
city: Shah Alam
country: Malaysia
facility: Klinik Dan Surgeri Alpha Medic
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Klinik Medic Bestari
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Klinik Medifom
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Victor Medical Practice
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Klinik Medijaya
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Klinik Dr Nur Ainita
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Klinik Taipan
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Poliklinik Roshan
state: Selangor
city: Subang Jaya
country: Malaysia
facility: Klinik Kok dan Wendy
state: Selangor
city: Subang
country: Malaysia
facility: MAS Medical Centre
state: Selangor
Study officials:
affiliation: Ministry of Health, Malaysia
name: Teck Onn Lim, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: International Medical University Malaysia
name: Zaki M Mohd Zaher, FRCP
role: STUDY_CHAIR
References:
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.