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

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NCT00708370

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Study Location
Pfizer Investigational Site
Jitra, Kubang Pasu, Kedah, 06200, Malaysia
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dyslipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Subjects who are newly diagnosed with dyslipidemias.

2. Subjects must be lipid drug naive and eligible for statin therapy.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Subjects who cannot be contacted by telephone or handphone.


2. Subjects with uncontrolled primary hypothyroidism.

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NCT00708370
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy of a Counselling and Advisory Care for Health (COACH) Program in Dyslipidemic Patients.
Official Title  ICMJE 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).
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.
Detailed Description Educational / Counseling
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Dyslipidemia
Intervention  ICMJE
  • Other: COACH
    COACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks.
    Other Name: COACH plus Standard Care
  • Other: No intervention for placebo
    There will be no COACH health tele-counselling to patients randomized to Standard Care arm.
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: COACH
    Intervention: Other: COACH
  • Placebo Comparator: Standard Care
    Intervention: Other: No intervention for placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2010)		297
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2008)		325
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00708370
Other Study ID Numbers  ICMJE A2581162
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP