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

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Educational / Counseling

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50480
        • Pfizer Investigational Site
      • Kuala Lumpur, Malaysia, 52000
        • Pfizer Investigational Site
      • Melaka, Malaysia, 75460
        • Pfizer Investigational Site
      • Shah Alam, Malaysia, 40460
        • Pfizer Investigational Site
    • Kedah
      • Jitra, Kubang Pasu, Kedah, Malaysia, 06200
        • Pfizer Investigational Site
      • Kulim, Kedah, Malaysia, 09400
        • Pfizer Investigational Site
      • Sik, Kedah, Malaysia, 08200
        • Pfizer Investigational Site
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Pfizer Investigational Site
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Pfizer Investigational Site
      • Cheras, Kuala Lumpur, Malaysia, 55300
        • Pfizer Investigational Site
    • Negeri Sembilan
      • Nilai, Negeri Sembilan, Malaysia, 71800
        • Pfizer Investigational Site
      • Tampin, Negeri Sembilan, Malaysia, 73000
        • Pfizer Investigational Site
    • Perak
      • Bagan Serai, Perak, Malaysia, 34300
        • Pfizer Investigational Site
      • Lenggong, Perak, Malaysia, 33400
        • Pfizer Investigational Site
      • Slim River, Perak, Malaysia, 35860
        • Pfizer Investigational Site
    • Selangor
      • Kapar, Selangor, Malaysia, 42200
        • Pfizer Investigational Site
      • Petaling Jaya, Selangor, Malaysia, 46000
        • Pfizer Investigational Site
      • Puchong, Selangor, Malaysia, 47100
        • Pfizer Investigational Site
      • Sungai Buloh, Selangor, Malaysia, 47000
        • Pfizer Investigational Site
    • Terengganu
      • Kemaman, Terengganu, Malaysia, 24100
        • Pfizer Investigational Site
      • Kerteh, Kemaman, Terengganu, Malaysia, 24300
        • Pfizer Investigational Site
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 57000
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: 24 and 36 weeks from Baseline
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
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
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
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
24 and 36 weeks from Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

June 27, 2008

First Posted (Estimate)

July 2, 2008

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2581162

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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