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Completed

NCT Number: NCT02927808

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

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

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Key information

Conditions

Acute Coronary Syndrome Behavior Cardiovascular Diseases Health Behavior Heart Diseases Medication Adherence Myocardial Ischemia Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AHEPA University Hospital

Thessaloniki, 54636, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational interview

Behavioral

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.

Primary outcomes

  1. 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)

    Time frame: 12 months after discharge from hospital

Secondary outcomes

  1. 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

    Time frame: 12 months after discharge from hospital

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Registry information

Acronym: IDEAL-LDL

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2016
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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