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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

770

participants targeted

Target at P75+ for phase_4 hypertension

Timeline

Completed

Started Aug 2007

Geographic Reach

1 country

78 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

June 21, 2007

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed

1 month until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed

Last Updated

April 7, 2015

Status Verified

April 1, 2010

Enrollment Period

1.3 years

First QC Date

June 21, 2007

Last Update Submit

April 6, 2015

Conditions

Hypertension Diabetes Mellitus Hyperlipidemia

Keywords

HypertensionDiabetes MellitusHyperlipidaemiaPrimary CareCommunity CareMultiple Risk Factors Interventional Strategies

Outcome Measures

Primary Outcomes (1)

Proportion of patients able to reach treatment goals.
6 months follow up

Secondary Outcomes (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.
6 months follow up

Study Arms (2)

Control Arm

OTHER

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

Behavioral: No Active Intervention.

CORFIS Arm

ACTIVE COMPARATOR

Community based Multiple Risk Factor Intervention Strategies

Behavioral: Community Based Multiple Risk Factor Intervention Strategies

Interventions

No Active Intervention.BEHAVIORAL

Conventional Chronic Disease Management in Malaysia Primary Care

Also known as: Control

Control Arm

Community Based Multiple Risk Factor Intervention StrategiesBEHAVIORAL

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

Also known as: CORFIS

CORFIS Arm

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Ministry of Health, Malaysialead

Study Sites (78)

Klinik Dr Khalil

Kuala Lumpur, Federal Territoy, 52100, Malaysia

Location

Horeb Sdn Bhd

Kuala Lumpur, Kuala Lumpur, 50250, Malaysia

Location

Klinik Tan & Mano Sdn Bhd

Kuala Lumpur, Kuala Lumpur, 50450, Malaysia

Location

Klinik Kaulsay

Kuala Lumpur, Kuala Lumpur, 50490, Malaysia

Location

Klinik Unimed Plaza Damansara

Kuala Lumpur, Kuala Lumpur, 50490, Malaysia

Location

Poliklinik Kumpulan City (Plaza Damansara)

Kuala Lumpur, Kuala Lumpur, 50490, Malaysia

Location

Klinik Shafi

Kuala Lumpur, Kuala Lumpur, 52000, Malaysia

Location

Poliklinik Kepong Baru

Kuala Lumpur, Kuala Lumpur, 52100, Malaysia

Location

Klinik Chew

Kuala Lumpur, Kuala Lumpur, 53000, Malaysia

Location

Klinik Reddy Setapak

Kuala Lumpur, Kuala Lumpur, 53000, Malaysia

Location

Klinik Medik (Dr Amir & Rakan-Rakan)

Kuala Lumpur, Kuala Lumpur, 53100, Malaysia

Location

Klinik Keluarga

Kuala Lumpur, Kuala Lumpur, 53300, Malaysia

Location

Klinik Vicky

Kuala Lumpur, Kuala Lumpur, 53300, Malaysia

Location

Klinik Care Poliklinik & Surgeri

Kuala Lumpur, Kuala Lumpur, 56100, Malaysia

Location

Klinik Tenaga Baru

Kuala Lumpur, Kuala Lumpur, 56100, Malaysia

Location

Kumpulan Medi-Systems Sdn Bhd

Kuala Lumpur, Kuala Lumpur, 56100, Malaysia

Location

Poliklinik Salak Selatan

Kuala Lumpur, Kuala Lumpur, 57100, Malaysia

Location

Klinik Sharon

Kuala Lumpur, Kuala Lumpur, 58200, Malaysia

Location

Klinik Medi Pesona

Kuala Lumpur, Kuala Lumpur, 59000, Malaysia

Location

Klinik Sharani

Kuala Lumpur, Kuala Lumpur, 59000, Malaysia

Location

Klinik Prime Care

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

PoliKlinik Bangsar

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Poliklinik Medics

Kuala Lumpur, Kuala Lumpur, 59200, Malaysia

Location

Klinik Famili TTDI

Kuala Lumpur, Kuala Lumpur, 60000, Malaysia

Location

Klinik Ehsan

Mentakab, Pahang, 28400, Malaysia

Location

Klinik Dan Surgeri Putra