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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)

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ClinicalTrials.gov Identifier: NCT02927808
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Leonidas Lillis, 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Behavioral: Motivational Interview Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Intervention group - 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.
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.

No Intervention: Control group
Patients assigned to the control group will be contacted for a pre-specified in-person interview plus lipid profiling at 1 year after discharge.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927808


Contacts
Contact: Leonidas Lillis, MD +30 2313 303 567 leonidaslillis@gmail.com
Contact: Georgios Giannakoulas, MD, PhD +30 2313 303 830 g.giannakoulas@gmail.com

Locations
Greece
AHEPA University Hospital Recruiting
Thessaloniki, Greece, 54636
Contact: Leonidas Lillis, MD    +30 2313 303 567    leonidaslillis@gmail.com   
Contact: George Giannakoulas, MD, PhD    +30 2313 303 830    g.giannakoulas@gmail.com   
Principal Investigator: George Giannakoulas, MD, PhD         
Principal Investigator: Leonidas Lillis, MD         
Principal Investigator: Athanasios Koutsakis, MD         
Sponsors and Collaborators
AHEPA University Hospital

Responsible Party: Leonidas Lillis, MD, Clinical Research Associate, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT02927808     History of Changes
Other Study ID Numbers: 22904/25.5.2016
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Leonidas Lillis, AHEPA University Hospital:
Motivational Interviewing
LDL-C
LDL target
Medication adherence

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases