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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)

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Motivational Interview

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Motivational Interviewing, LDL-C, LDL target, Medication adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

AHEPA University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group - Motivational Interview

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02927808

First Posted

October 6, 2016

Last Updated

November 15, 2020

Sponsor

AHEPA University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02927808

Brief 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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

April 2020 (Actual)

Study Completion Date

April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

AHEPA University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Motivational Interviewing, LDL-C, LDL target, Medication adherence

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group - Motivational Interview

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Motivational Interview

Intervention Description

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 Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

AHEPA University Hospital

City

Thessaloniki

ZIP/Postal Code

54636

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35345248

Citation

Kourti O, Konstantas O, Farmakis ITau, Zafeiropoulos S, Psarakis G, Vrana E, Baroutidou A, Graidis S, Touriki AV, Tsolakidis C, Spyridaki K, Psathas T, Daniilidou A, Karvounis H, Giannakoulas G. Potent P2Y12 inhibitors versus clopidogrel to predict adherence to antiplatelet therapy after an acute coronary syndrome: insights from IDEAL-LDL. Rev Cardiovasc Med. 2022 Mar 3;23(3):81. doi: 10.31083/j.rcm2303081.

Results Reference

derived

PubMed Identifier

33780749

Citation

Zafeiropoulos S, Farmakis I, Kartas A, Arvanitaki A, Pagiantza A, Boulmpou A, Tampaki A, Kosmidis D, Nevras V, Markidis E, Papadimitriou I, Vlachou A, Arvanitakis K, Miyara SJ, Ziakas A, Molmenti EP, Kassimis G, Zanos S, Karvounis H, Giannakoulas G. Reinforcing adherence to lipid-lowering therapy after an acute coronary syndrome: A pragmatic randomized controlled trial. Atherosclerosis. 2021 Apr;323:37-43. doi: 10.1016/j.atherosclerosis.2021.03.013. Epub 2021 Mar 17.

Results Reference

derived

Learn more about this trial

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

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