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

NCT02927808 | Completed

• 1 other identifier: 22904/25.5.2016
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

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

Outcome Measures

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)

  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

  12 months after discharge from hospital

Study Arms (2)

Intervention group - Motivational Interview

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Intervention group - Motivational Interview

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHEPA University Hospital: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

Related Publications (2)

• 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.

  PMID: 35345248 DERIVED

• 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.

  PMID: 33780749 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Medication Adherence

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Clinical Research Associate

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)