Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COACH | Active Comparator |
| |
| Standard Care | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COACH | Other | COACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) change from baseline to week 24 in serum LDL-C levels. | 24 weeks from Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Jitra, Kubang Pasu | Kedah | 06200 | Malaysia | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23046818 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No intervention for placebo | Other | There will be no COACH health tele-counselling to patients randomized to Standard Care arm. |
|
|
| 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 |
| Kulim |
| Kedah |
| 09400 |
| Malaysia |
| Pfizer Investigational Site | Sik | Kedah | 08200 | Malaysia |
| Pfizer Investigational Site | Kubang Kerian | Kelantan | 16150 | Malaysia |
| Pfizer Investigational Site | Cheras | Kuala Lumpur | 55300 | Malaysia |
| Pfizer Investigational Site | Cheras | Kuala Lumpur | 56000 | Malaysia |
| Pfizer Investigational Site | Kuala Lumpur | Kuala Lumpur | 57000 | Malaysia |
| Pfizer Investigational Site | Kampung Baharu Nilai | Negeri Sembilan | 71800 | Malaysia |
| Pfizer Investigational Site | Tampin | Negeri Sembilan | 73000 | Malaysia |
| Pfizer Investigational Site | Bagan Serai | Perak | 34300 | Malaysia |
| Pfizer Investigational Site | Lenggong | Perak | 33400 | Malaysia |
| Pfizer Investigational Site | Slim River | Perak | 35860 | Malaysia |
| Pfizer Investigational Site | Kapar | Selangor | 42200 | Malaysia |
| Pfizer Investigational Site | Petaling Jaya | Selangor | 46000 | Malaysia |
| Pfizer Investigational Site | Puchong | Selangor | 47100 | Malaysia |
| Pfizer Investigational Site | Sungai Buloh | Selangor | 47000 | Malaysia |
| Pfizer Investigational Site | Kampong Kemaman | Terengganu | 24100 | Malaysia |
| Pfizer Investigational Site | Kerteh, Kemaman | Terengganu | 24300 | Malaysia |
| Pfizer Investigational Site | Kuala Lumpur | 50480 | Malaysia |
| Pfizer Investigational Site | Kuala Lumpur | 52000 | Malaysia |
| Pfizer Investigational Site | Malacca | 75460 | Malaysia |
| Pfizer Investigational Site | Shah Alam | 40460 | Malaysia |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided