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

Viatris

Status and phase: Completed; Phase 4

Conditions: Dyslipidemia

Treatments: Other: COACH; Other: No intervention for placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708370

A2581162

Details and patient eligibility

About

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.

Full description

Educational / Counseling

Enrollment: 297 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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297 participants in 2 patient groups, including a placebo group

COACH

Active Comparator group

Treatment:

Other: COACH

Standard Care

Placebo Comparator group

Treatment:

Other: No intervention for placebo