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Community Based Multiple Risk...

Community Based Multiple Risk Factors Intervention Strategy

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension Diabetes Mellitus Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Arm

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

Group Type OTHER

No Active Intervention.

Intervention Type BEHAVIORAL

Conventional Chronic Disease Management in Malaysia Primary Care

CORFIS Arm

Community based Multiple Risk Factor Intervention Strategies

Group Type ACTIVE_COMPARATOR

Community Based Multiple Risk Factor Intervention Strategies

Intervention Type BEHAVIORAL

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

Interventions

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No Active Intervention.

Conventional Chronic Disease Management in Malaysia Primary Care

Intervention Type BEHAVIORAL

Community Based Multiple Risk Factor Intervention Strategies

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Control CORFIS

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Clinical Research Centre, Hospital Kuala Lumpur

Principal Investigators

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Teck Onn Lim, FRCP

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Malaysia

Zaki M Mohd Zaher, FRCP

Role: STUDY_CHAIR

International Medical University Malaysia

Locations

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