Community Based Multiple Risk Factors Intervention Strategy
Condition: Hypertension; Diabetes Mellitus; Hyperlipidemia
MeSH terms: Hypertension; Diabetes Mellitus; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): No Active Intervention.; Community Based Multiple Risk Factor Intervention Strategies
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Conventional Chronic Disease Management in Malaysia Primary Care; Multi-faceted Intervention in Chronic Diseases Management i.e. Hypertension, Diabetes Mellitus, Hyperlipidaemia involving Primary Health Care Physicians, Nurse Educators, Dieticians and Pharmacists.
Other intervention name(s): Control; CORFIS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Diabetes Mellitus; Hyperlipidaemia; Primary Care; Community Care; Multiple Risk Factors Interventional Strategies