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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.297 enrolled

Overview

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.

Educational / Counseling

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

297

Conditions

Dyslipidemia

Interventions

COACHOTHER

COACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks.

No intervention for placeboOTHER

There will be no COACH health tele-counselling to patients randomized to Standard Care arm.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects who are newly diagnosed with dyslipidemias. 2. Subjects must be lipid drug naive and eligible for statin therapy. Exclusion Criteria: 1. Subjects who cannot be contacted by telephone or handphone. 2. Subjects with uncontrolled primary hypothyroidism.

Locations (22)

Pfizer Investigational Site

Jitra, Kubang Pasu, Kedah, Malaysia

Outcomes

Primary Outcomes

Percentage (%) change from baseline to week 24 in serum LDL-C levels.

Time frame: 24 weeks from Baseline

Secondary Outcomes

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.

Time frame: 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).

Time frame: 24 and 36 weeks from Baseline

Subjects' satisfaction with the Health Booklet and the COACH program after 24 weeks.

Time frame: 24 weeks from Baseline

Absolute change in SBP and DBP from baseline to weeks 24 and 36.

Time frame: 24 and 36 weeks from Baseline

Percentage (%) change in Framingham CHD risk score from baseline to weeks 24 and 36.

Time frame: 24 and 36 weeks from Baseline

Data from ClinicalTrials.gov

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