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

NCT00708370 | Completed Phase 4

• 1 other identifier: A2581162
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Dyslipidemia

Keywords

Interventional; Non-drug; Disease Management Program; Cardiovascular Risk Control; Dyslipidemias; Primary Care Centers

Outcome Measures

Primary Outcomes (1)

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

  24 weeks from Baseline

Secondary Outcomes (5)

• 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

Study Arms (2)

COACH

ACTIVE COMPARATOR

Other: COACH

Standard Care

PLACEBO COMPARATOR

Other: No intervention for placebo

Interventions

COACH OTHER

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

Also known as: COACH plus Standard Care

COACH

No intervention for placebo OTHER

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

Also known as: Placebo

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are newly diagnosed with dyslipidemias.
• Subjects must be lipid drug naive and eligible for statin therapy.

You may not qualify if:

• Subjects who cannot be contacted by telephone or handphone.
• Subjects with uncontrolled primary hypothyroidism.

Sponsors & Collaborators

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

Study Sites (22)

Pfizer Investigational Site

Jitra, Kubang Pasu, Kedah, 06200, Malaysia

Location

Pfizer Investigational Site

Kulim, Kedah, 09400, Malaysia

Location

Pfizer Investigational Site

Sik, Kedah, 08200, Malaysia

Location

Pfizer Investigational Site

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Pfizer Investigational Site

Cheras, Kuala Lumpur, 55300, Malaysia

Location

Pfizer Investigational Site

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Pfizer Investigational Site

Kuala Lumpur, Kuala Lumpur, 57000, Malaysia

Location

Pfizer Investigational Site

Kampung Baharu Nilai, Negeri Sembilan, 71800, Malaysia

Location

Pfizer Investigational Site

Tampin, Negeri Sembilan, 73000, Malaysia

Location

Pfizer Investigational Site

Bagan Serai, Perak, 34300, Malaysia

Location

Pfizer Investigational Site

Lenggong, Perak, 33400, Malaysia

Location

Pfizer Investigational Site

Slim River, Perak, 35860, Malaysia

Location

Pfizer Investigational Site

Kapar, Selangor, 42200, Malaysia

Location

Pfizer Investigational Site

Petaling Jaya, Selangor, 46000, Malaysia

Location

Pfizer Investigational Site

Puchong, Selangor, 47100, Malaysia

Location

Pfizer Investigational Site

Sungai Buloh, Selangor, 47000, Malaysia

Location

Pfizer Investigational Site

Kampong Kemaman, Terengganu, 24100, Malaysia

Location

Pfizer Investigational Site

Kerteh, Kemaman, Terengganu, 24300, Malaysia

Location

Pfizer Investigational Site

Kuala Lumpur, 50480, Malaysia

Location

Pfizer Investigational Site

Kuala Lumpur, 52000, Malaysia

Location

Pfizer Investigational Site

Malacca, 75460, Malaysia

Location

Pfizer Investigational Site

Shah Alam, 40460, Malaysia

Location

Related Publications (1)

• Selvaraj FJ, Mohamed M, Omar K, Nanthan S, Kusiar Z, Subramaniam SY, Ali N, Karanakaran K, Ahmad F, Low WH; DISSEMINATE study group. The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial. BMC Fam Pract. 2012 Oct 10;13:97. doi: 10.1186/1471-2296-13-97.

  PMID: 23046818 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dyslipidemias

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 2, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

MY (22)