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OpenTrials
Completed

NCT Number: NCT00708370

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

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Jitra, Kubang Pasu, Kedah, Malaysia

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About this study

Educational / Counseling

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COACH

Other

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

Other names: COACH plus Standard Care

No intervention for placebo

Other

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

Other names: Placebo

Primary outcomes

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

    Time frame: 24 weeks from Baseline

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: 24 weeks from Baseline

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

    Time frame: 24 and 36 weeks from Baseline

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

    Time frame: 24 and 36 weeks from Baseline

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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).

Acronym: DISSEMINATE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 2, 2008
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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