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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
COACH
No intervention for placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dyslipidemia focused on measuring Interventional, Non-drug, Disease Management Program, Cardiovascular Risk Control, Dyslipidemias, Primary Care Centers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

COACH

Standard Care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
Subjects' satisfaction with the Health Booklet and the COACH program after 24 weeks.
Absolute change in SBP and DBP from baseline to weeks 24 and 36.
Percentage (%) change in Framingham CHD risk score from baseline to weeks 24 and 36.

Full Information

First Posted
June 27, 2008
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00708370
Brief Title
A Study to Evaluate the Efficacy of a Counselling and Advisory Care for Health (COACH) Program in Dyslipidemic Patients.
Acronym
DISSEMINATE
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Interventional, Non-drug, Disease Management Program, Cardiovascular Risk Control, Dyslipidemias, Primary Care Centers

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
297 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COACH
Arm Type
Active Comparator
Arm Title
Standard Care
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
COACH
Other Intervention Name(s)
COACH plus Standard Care
Intervention Description
COACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks.
Intervention Type
Other
Intervention Name(s)
No intervention for placebo
Other Intervention Name(s)
Placebo
Intervention Description
There will be no COACH health tele-counselling to patients randomized to Standard Care arm.
Primary Outcome Measure Information:
Title
Percentage (%) change from baseline to week 24 in serum LDL-C levels.
Time Frame
24 weeks from Baseline
Secondary Outcome Measure Information:
Title
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.
Time Frame
24 and 36 weeks from Baseline
Title
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).
Time Frame
24 and 36 weeks from Baseline
Title
Subjects' satisfaction with the Health Booklet and the COACH program after 24 weeks.
Time Frame
24 weeks from Baseline
Title
Absolute change in SBP and DBP from baseline to weeks 24 and 36.
Time Frame
24 and 36 weeks from Baseline
Title
Percentage (%) change in Framingham CHD risk score from baseline to weeks 24 and 36.
Time Frame
24 and 36 weeks from Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who are newly diagnosed with dyslipidemias. Subjects must be lipid drug naive and eligible for statin therapy. Exclusion Criteria: Subjects who cannot be contacted by telephone or handphone. Subjects with uncontrolled primary hypothyroidism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Jitra, Kubang Pasu
State/Province
Kedah
ZIP/Postal Code
06200
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kulim
State/Province
Kedah
ZIP/Postal Code
09400
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Sik
State/Province
Kedah
ZIP/Postal Code
08200
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
55300
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Nilai
State/Province
Negeri Sembilan
ZIP/Postal Code
71800
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Tampin
State/Province
Negeri Sembilan
ZIP/Postal Code
73000
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Bagan Serai
State/Province
Perak
ZIP/Postal Code
34300
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Lenggong
State/Province
Perak
ZIP/Postal Code
33400
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Slim River
State/Province
Perak
ZIP/Postal Code
35860
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kapar
State/Province
Selangor
ZIP/Postal Code
42200
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Petaling Jaya
State/Province
Selangor
ZIP/Postal Code
46000
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Puchong
State/Province
Selangor
ZIP/Postal Code
47100
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Sungai Buloh
State/Province
Selangor
ZIP/Postal Code
47000
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kemaman
State/Province
Terengganu
ZIP/Postal Code
24100
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kerteh, Kemaman
State/Province
Terengganu
ZIP/Postal Code
24300
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
57000
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
50480
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
52000
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Melaka
ZIP/Postal Code
75460
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Shah Alam
ZIP/Postal Code
40460
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23046818
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581162&StudyName=A%20Study%20to%20Evaluate%20the%20Efficacy%20of%20a%20Counselling%20and%20Advisory%20Care%20for%20Health%20%28COACH%29%20Program%20in%20Dyslipidemic%20Patients.
Description
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A Study to Evaluate the Efficacy of a Counselling and Advisory Care for Health (COACH) Program in Dyslipidemic Patients.

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