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).

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00708370

Acronym

DISSEMINATE

Enrollment

297

Registered

2008-07-02

Start date

2008-08-31

Completion date

2010-06-30

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

Interventional, Non-drug, Disease Management Program, Cardiovascular Risk Control, Dyslipidemias, Primary Care Centers

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

Interventions

OTHERCOACH

COACH Nurse will provide health tele-counselling to patients randomized to COACH arm fortnightly for 24 weeks.

OTHERNo intervention for placebo

There will be no COACH health tele-counselling to patients randomized to Standard Care arm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Percentage (%) change from baseline to week 24 in serum LDL-C levels.	24 weeks from Baseline

Secondary

Measure	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).	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

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026