Clinical trial NCT00708370: A Study to Evaluate the Efficacy of a Counselling and Advisory Care for Health (COACH) Program in Dyslipidemic Patients.
Official 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: Interventional
Non-drug
Disease Management Program
Cardiovascular Risk Control
Dyslipidemias
Primary Care Centers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage (%) change from baseline to week 24 in serum LDL-C levels.
timeFrame: 24 weeks from Baseline
Secondary outcomes:
measure: 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.
timeFrame: 24 and 36 weeks from Baseline
measure: 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).
timeFrame: 24 and 36 weeks from Baseline
measure: Subjects' satisfaction with the Health Booklet and the COACH program after 24 weeks.
timeFrame: 24 weeks from Baseline
measure: Absolute change in SBP and DBP from baseline to weeks 24 and 36.
timeFrame: 24 and 36 weeks from Baseline
measure: Percentage (%) change in Framingham CHD risk score from baseline to weeks 24 and 36.
timeFrame: 24 and 36 weeks from Baseline
Other outcomes:
Locations:
city: Jitra, Kubang Pasu
country: Malaysia
facility: Pfizer Investigational Site
state: Kedah
city: Kulim
country: Malaysia
facility: Pfizer Investigational Site
state: Kedah
city: Sik
country: Malaysia
facility: Pfizer Investigational Site
state: Kedah
city: Kubang Kerian
country: Malaysia
facility: Pfizer Investigational Site
state: Kelantan
city: Cheras
country: Malaysia
facility: Pfizer Investigational Site
state: Kuala Lumpur
city: Cheras
country: Malaysia
facility: Pfizer Investigational Site
state: Kuala Lumpur
city: Nilai
country: Malaysia
facility: Pfizer Investigational Site
state: Negeri Sembilan
city: Tampin
country: Malaysia
facility: Pfizer Investigational Site
state: Negeri Sembilan
city: Bagan Serai
country: Malaysia
facility: Pfizer Investigational Site
state: Perak
city: Lenggong
country: Malaysia
facility: Pfizer Investigational Site
state: Perak
city: Slim River
country: Malaysia
facility: Pfizer Investigational Site
state: Perak
city: Kapar
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Petaling Jaya
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Puchong
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Sungai Buloh
country: Malaysia
facility: Pfizer Investigational Site
state: Selangor
city: Kemaman
country: Malaysia
facility: Pfizer Investigational Site
state: Terengganu
city: Kerteh, Kemaman
country: Malaysia
facility: Pfizer Investigational Site
state: Terengganu
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Melaka
country: Malaysia
facility: Pfizer Investigational Site
city: Shah Alam
country: Malaysia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.