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

Acute Coronary Syndrome Clinical Trial

— IDEAL-LDL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927808
• Other study ID #: 22904/25.5.2016
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 2020

Study information

• Verified date: November 2020
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Behavioral:
• Motivational Interview
Informational leaflet about the risks of high LDL-C and the importance of adherence to lipid-lowering medication in patients with coronary artery disease. Follow-up motivational interviewing at 1 and 6 months after discharge.

Locations

Country	Name	City	State
Greece	AHEPA University Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AHEPA University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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