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NCT00708370 Clinical Trial

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

Dyslipidemia Clinical Trial

— DISSEMINATE  

Official title:
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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00708370
Other study ID # A2581162
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2008
Est. completion date June 2010

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

Educational / Counseling

Recruitment information / eligibility
Status Completed
Enrollment 297
Est. completion date June 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• COACH
COACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks.
• No intervention for placebo
There will be no COACH health tele-counselling to patients randomized to Standard Care arm.

Locations
Country Name City State
Malaysia Pfizer Investigational Site Bagan Serai Perak
Malaysia Pfizer Investigational Site Cheras Kuala Lumpur
Malaysia Pfizer Investigational Site Cheras Kuala Lumpur
Malaysia Pfizer Investigational Site Jitra, Kubang Pasu Kedah
Malaysia Pfizer Investigational Site Kapar Selangor
Malaysia Pfizer Investigational Site Kemaman Terengganu
Malaysia Pfizer Investigational Site Kerteh, Kemaman Terengganu
Malaysia Pfizer Investigational Site Kuala Lumpur Wilayah Persekutuan
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Kuala Lumpur
Malaysia Pfizer Investigational Site Kubang Kerian Kelantan
Malaysia Pfizer Investigational Site Kulim Kedah
Malaysia Pfizer Investigational Site Lenggong Perak
Malaysia Pfizer Investigational Site Melaka
Malaysia Pfizer Investigational Site Nilai Negeri Sembilan
Malaysia Pfizer Investigational Site Petaling Jaya Selangor
Malaysia Pfizer Investigational Site Puchong Selangor
Malaysia Pfizer Investigational Site Shah Alam
Malaysia Pfizer Investigational Site Sik Kedah
Malaysia Pfizer Investigational Site Slim River Perak
Malaysia Pfizer Investigational Site Sungai Buloh Selangor
Malaysia Pfizer Investigational Site Tampin Negeri Sembilan

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage (%) change from baseline to week 24 in serum LDL-C levels. 24 weeks from Baseline
Secondary 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
Secondary 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
Secondary Subjects' satisfaction with the Health Booklet and the COACH program after 24 weeks. 24 weeks from Baseline
Secondary Absolute change in SBP and DBP from baseline to weeks 24 and 36. 24 and 36 weeks from Baseline
Secondary Percentage (%) change in Framingham CHD risk score from baseline to weeks 24 and 36. 24 and 36 weeks from Baseline
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