A Study to Evaluate the Efficacy of a Counselling and Advisory Care for Health (COACH) Program in Dyslipidemic Patients.

Study Overview
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Brief Summary
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This study is a local PCO sponsored, interventional, non-drug study to evaluate the efficacy of a health tele-counselling program in reducing cardiovascular risk in dyslipidemic patients.

Detailed Description
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Educational / Counseling

Official Title
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An Outcome Research on the Impact of a Disease Management Program (COACH) on the Attainment of Better Cardiovascular Risk Control in Dyslipidemic Patients at Primary Care Centers (DISSEMINATE).

Conditions
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Dyslipidemia

Intervention / Treatment
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* Other: COACH
* Other: No intervention for placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are newly diagnosed with dyslipidemias. Subjects must be lipid drug naive and eligible for statin therapy. Exclusion Criteria: Subjects who cannot be contacted by telephone or handphone. Subjects with uncontrolled primary hypothyroidism.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COACH<br> | Other: COACH<br>* COACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks.<br>* Other names: COACH plus Standard Care;|
| Placebo Comparator: Standard Care<br> | Other: No intervention for placebo<br>* There will be no COACH health tele-counselling to patients randomized to Standard Care arm.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) change from baseline to week 24 in serum LDL-C levels. |  | 24 weeks from Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects' lifestyle modification as assessed by the incidence and frequency of smoking, consumption of foods high in salt, sugar and/or fat content, alcohol consumption, and exercise habits at baseline and weeks 24 and 36. |  | 24 and 36 weeks from Baseline | 
| Percentage (%) change from baseline in serum LDL-C (week 36), TC (week 24 and 36), HDL-C (week 24 and 36), TG (week 24 and 36) and TC/HDL-C ratio (week 24 and 36). |  | 24 and 36 weeks from Baseline | 
| Subjects' satisfaction with the Health Booklet and the COACH program after 24 weeks. |  | 24 weeks from Baseline | 
| Absolute change in SBP and DBP from baseline to weeks 24 and 36. |  | 24 and 36 weeks from Baseline | 
| Percentage (%) change in Framingham CHD risk score from baseline to weeks 24 and 36. |  | 24 and 36 weeks from Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interventional, Non-drug, Disease Management Program, Cardiovascular Risk Control, Dyslipidemias, Primary Care Centers