AzTrials
AzTrials

HypertensionPhase 4CORFISNCT00490672

Community Based Multiple Risk Factors Intervention Strategy

A Phase 4 study testing No Active Intervention. and Community Based Multiple Risk Factor Intervention Strategies in people with Hypertension and Diabetes Mellitus, run by Ministry of Health, Malaysia at 78 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertension, Diabetes Mellitus, Hyperlipidemia
What is being tested?
No Active Intervention. and Community Based Multiple Risk Factor Intervention Strategies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
770 participants
Where
78 sitesMalaysia
Study dates
Aug 2007to Jan 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

78 sites in 1 country.

78 sites in 1 country

Malaysia78 sites

  • Klinik Dan Surgeri Putra

    Ampang, Selangor, 68000

  • Klinik Idzham Sdn Bhd

    Ampang, Selangor, 68000

  • Klinik Mediviron

    Ampang, Selangor, 68000

  • Klinik Putera (Poliklinik Bistari)

    Ampang, Selangor, 68000

  • Klinik Tan & Mano

    Ampang, Selangor, 68000

  • Poliklinik Gomez 24 Jam

    Ampang, Selangor, 68000

  • Poliklinik Penawar

    Ampang, Selangor, 68000

  • Klinik Hayati (Poliklinik & Surgeri)

    Batu Caves, Selangor, 68100

  • Klinik Nathan Dan Rakan-Rakan

    Batu Caves, Selangor, 68100

  • Poliklinik Idaman

    Batu Caves, Selangor, 68100

  • Poliklinik Kumpulan City

    Batu Caves, Selangor, 68100

  • MAS Medical Centre

    Kampung Baru Subang, Selangor, 47200

  • Klinik Keluarga Azian & Elina

    Klang, Selangor, 41000

  • Klinik Keluarga Siva Lim

    Klang, Selangor, 41300

  • Lok Dispensary

    Klang, Selangor, 41300

  • Klinik Bandaran

    Klang, Selangor, 41400

  • Klinik Kelang

    Klang, Selangor, 41400

  • Klinik Lim

    Klang, Selangor, 41400

  • Klinik Yuen

    Klang, Selangor, 41400

  • Klinik Stella Maris Sdn Bhd

    Klang, Selangor, 42000

  • Klinik Utama

    Klang, Selangor, 42000

  • Klinik Wan Elina

    Klang, Selangor, 42000

  • Poliklinik Hari

    Klang, Selangor, 42000

  • Klinik Ng & Lim

    Klang, Selangor, 42100

  • Klinik Dr Khalil

    Kuala Lumpur, Federal Territoy, 52100

  • Horeb Sdn Bhd

    Kuala Lumpur, Kuala Lumpur, 50250

  • Klinik Tan & Mano Sdn Bhd

    Kuala Lumpur, Kuala Lumpur, 50450

  • Klinik Kaulsay

    Kuala Lumpur, Kuala Lumpur, 50490

  • Klinik Unimed Plaza Damansara

    Kuala Lumpur, Kuala Lumpur, 50490

  • Poliklinik Kumpulan City (Plaza Damansara)

    Kuala Lumpur, Kuala Lumpur, 50490

  • Klinik Shafi

    Kuala Lumpur, Kuala Lumpur, 52000

  • Poliklinik Kepong Baru

    Kuala Lumpur, Kuala Lumpur, 52100

  • Klinik Chew

    Kuala Lumpur, Kuala Lumpur, 53000

  • Klinik Reddy Setapak

    Kuala Lumpur, Kuala Lumpur, 53000

  • Klinik Medik (Dr Amir & Rakan-Rakan)

    Kuala Lumpur, Kuala Lumpur, 53100

  • Klinik Keluarga

    Kuala Lumpur, Kuala Lumpur, 53300

  • Klinik Vicky

    Kuala Lumpur, Kuala Lumpur, 53300

  • Klinik Care Poliklinik & Surgeri

    Kuala Lumpur, Kuala Lumpur, 56100

  • Klinik Tenaga Baru

    Kuala Lumpur, Kuala Lumpur, 56100

  • Kumpulan Medi-Systems Sdn Bhd

    Kuala Lumpur, Kuala Lumpur, 56100

  • Poliklinik Salak Selatan

    Kuala Lumpur, Kuala Lumpur, 57100

  • Klinik Sharon

    Kuala Lumpur, Kuala Lumpur, 58200

  • Klinik Medi Pesona

    Kuala Lumpur, Kuala Lumpur, 59000

  • Klinik Sharani

    Kuala Lumpur, Kuala Lumpur, 59000

  • Klinik Prime Care

    Kuala Lumpur, Kuala Lumpur, 59100

  • PoliKlinik Bangsar

    Kuala Lumpur, Kuala Lumpur, 59100

  • Poliklinik Medics

    Kuala Lumpur, Kuala Lumpur, 59200

  • Klinik Famili TTDI

    Kuala Lumpur, Kuala Lumpur, 60000

  • Klinik Ehsan

    Mentakab, Pahang, 28400

  • Klinik Khaty Am

    Petaling Jaya, Selangor, 46000

  • Poliklinik Shaik (Sunway) Sdn Bhd

    Petaling Jaya, Selangor, 46150

  • Klinik Primecare

    Petaling Jaya, Selangor, 46350

  • Klinik Petaling Jaya

    Petaling Jaya, Selangor, 47300

  • Klinik Alam Medic

    Petaling Jaya, Selangor, 47301

  • Klinik Rakan Medik

    Petaling Jaya, Selangor, 47301

  • Poliklinik Rakyat

    Petaling Jaya, Selangor, 47301

  • Klinik Kelana Puteri

    Petaling Jaya, Selangor, 47601

  • Klinik Ready Care

    Petaling Jaya, Selangor, 47800

  • Poliklinik Hidayah

    Petaling Jaya, Selangor, 47810

  • Klinik Dr Shamsuddin

    Petaling Jaya, Selangor, 47830

  • Klinik Hafiz

    Puchong, Selangor, 47100

  • Klinik Leong

    Puchong, Selangor, 47100

  • Klinik Raya

    Puchong, Selangor, 47100

  • Klinik Reddy

    Puchong, Selangor, 58200

  • Klinik Ng Singh & Rakan-Rakan

    Rawang, Selangor, 48000

  • Klinik Sarrimadh

    Seri Kembangan, Selangor, 43300

  • Klinik Bandaran Sdn Bhd

    Shah Alam, Selangor, 40000

  • Klinik Kelang

    Shah Alam, Selangor, 40000

  • Poliklinik Sri Muda

    Shah Alam, Selangor, 40400

  • Klinik Dan Surgeri Alpha Medic

    Shah Alam, Selangor, 42450

  • Klinik Medic Bestari

    Subang Jaya, Selangor, 47500

  • Klinik Medifom

    Subang Jaya, Selangor, 47600

  • Victor Medical Practice

    Subang Jaya, Selangor, 47600

  • Klinik Medijaya

    Subang Jaya, Selangor, 47610

  • Klinik Dr Nur Ainita

    Subang Jaya, Selangor, 47620

  • Klinik Taipan

    Subang Jaya, Selangor, 47620

  • Poliklinik Roshan

    Subang Jaya, Selangor, 47620

  • Klinik Kok dan Wendy

    Subang Jaya, Selangor, 47630

Other trials in Malaysia

About this study

Official title: 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.
Read the 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.

Being tested
No Active Intervention., Community Based Multiple Risk Factor Intervention Strategies
Keywords
Hypertension, Diabetes Mellitus, Hyperlipidaemia, Primary Care, Community Care, Multiple Risk Factors Interventional Strategies
Medical subject headings
Hypertension, Diabetes Mellitus, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Active Intervention.Behavioural

    Also called Control

    Conventional Chronic Disease Management in Malaysia Primary Care

  • Community Based Multiple Risk Factor Intervention StrategiesBehavioural

    Also called CORFIS

    Multi-faceted Intervention in Chronic Diseases Management i.e. Hypertension, Diabetes Mellitus, Hyperlipidaemia involving Primary Health Care Physicians, Nurse Educators, Dieticians and Pharmacists.

Study groups in NCT00490672
Study groupRoleWhat they receive
Control ArmOtherConventional Patient Management on Hypertension, Diabetes Mellitus and Hyperlipidaemia by Malaysian GP
Receives: Behavioral: No Active Intervention.
CORFIS ArmActive comparatorCommunity based Multiple Risk Factor Intervention Strategies
Receives: Behavioral: Community Based Multiple Risk Factor Intervention Strategies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients able to reach treatment goals.

    Measured: 6 months follow up

Secondary outcomes (1)

  1. 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.

    Measured: 6 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionDec 2008
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
770 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00490672
Sponsor's protocol ID
CT07-02
Other IDs
NMRR ID Number: 447
Acronym
CORFIS
Status last verified
Apr 2010
First submitted
21 Jun 2007
Last updated
7 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23145922

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing No Active Intervention. and Community Based Multiple Risk Factor Intervention Strategies in people with Hypertension and Diabetes Mellitus, run by Ministry of Health, Malaysia at 78 sites in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients able to reach treatment goals. (time frame: 6 months follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00490672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in