Community Based Multiple Risk Factors Intervention Strategy (CORFIS)

Ministry of Health, Malaysia

Status and phase: Completed; Phase 4

Conditions: Hypertension; Hyperlipidemia; Diabetes Mellitus

Treatments: Behavioral: Community Based Multiple Risk Factor Intervention Strategies; Behavioral: No Active Intervention.

Study type: Interventional

Funder types: Other

Identifiers

NCT00490672

CT07-02

NMRR ID Number: 447

Details and patient eligibility

About

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.

Full 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.

Enrollment: 770 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

770 participants in 2 patient groups

Control Arm

Other group

Description:

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

Treatment:

Behavioral: No Active Intervention.

CORFIS Arm

Active Comparator group

Description:

Community based Multiple Risk Factor Intervention Strategies

Treatment:

Behavioral: Community Based Multiple Risk Factor Intervention Strategies