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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Jitra, Kubang Pasu, Kedah, 06200 Malaysia
Contact
1-800-718-1021
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.

NCT00708370
Pfizer
Completed
A Study to Evaluate the Efficacy of a Counselling and Advisory Care for Health (COACH) Program in Dyslipidemic Patients.

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A Study to Evaluate the Efficacy of a Counselling and Advisory Care for Health (COACH) Program in Dyslipidemic Patients.
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.
Educational / Counseling
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Dyslipidemia
  • 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
  • Active Comparator: COACH
    Intervention: Other: COACH
  • Placebo Comparator: Standard Care
    Intervention: Other: No intervention for placebo
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.
 
Completed
297
June 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
 
NCT00708370
A2581162
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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