Motivational Interviewing to Support LDL-C Therapeutic Goals and Lipid-Lowering Therapy Compliance in Patients With Acute Coronary Syndromes: a Prospective Randomized Clinical Study (IDEAL-LDL)

AHEPA University Hospital

Status: Completed

Conditions: Acute Coronary Syndrome

Treatments: Behavioral: Motivational Interview

Study type: Interventional

Funder types: Other

Identifiers

NCT02927808

22904/25.5.2016

Details and patient eligibility

About

This study will investigate the impact of motivational interviewing in achieving low-density lipoprotein cholesterol therapeutic targets in patients with acute coronary syndromes.

Full description

To determine whether a strategy of enhanced information about the risks of high plasma low-density lipoprotein cholesterol (LDL-C) and the importance of lipid-lowering medication together with close follow-up and motivational interviewing is superior than usual care in achieving LDL-C therapeutic targets, as set by current practice guidelines (LDL-C <70 mg/dL or >50% reduction from baseline LDL-C) in patients with acute coronary syndromes.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject hospitalized for acute coronary syndrome (STEMI, NTEMI or unstable angina)
• Subject currently on lipid-lowering therapy or prescribed lipid-lowering therapy at hospital discharge (statins and/or other agents)
• Subject who is 18 years or older
• Subject or legally authorized representative who is willing and capable of providing informed consent, participating in all associated study activities

Exclusion criteria

• Subject unable to communicate via telephone for study interviewing
• Subject with contraindication to statin therapy
• Subject with any medical disorder that would interfere with completion or evaluation of clinical study results

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Intervention group - Motivational Interview

Experimental group

Description:

Patients assigned to the intervention group will be given a leaflet entitled "Information leaflet about LDL Cholesterol" that will educate them about the risks of high LDL-C and the importance of adherence to lipid-lowering medication. Patients assigned to the intervention group will be contacted via telephone for a pre-specified interview (motivational interview again stressing the importance of adherence to lipid-lowering medication) at 1 month and 6 months after discharge, and for an in-person interview plus lipid profiling at 1 year after discharge.

Treatment:

Behavioral: Motivational Interview

Control group

No Intervention group

Description:

Patients assigned to the control group will be contacted for a pre-specified in-person interview plus lipid profiling at 1 year after discharge.