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

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Behavioral: Motivational Interview

• Registration Number: NCT02927808
• Lead Sponsor: AHEPA University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-07
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-15
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group - Motivational Interview	Motivational Interview	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.

Primary Outcome Measures

Name	Time	Method
Achievement of low-density lipoprotein cholesterol therapeutic goal, as specified by current practice guidelines (LDL-C <70 mg/dL or >50% reduction from baseline LDL-C)	12 months after discharge from hospital

Secondary Outcome Measures

Name	Time	Method
Overall adherence to lipid-lowering regimen, reported as both a continuous and a binary outcome, by using the 4-item Morisky Medication-Taking Adherence Scale	12 months after discharge from hospital

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece