Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC)

August 8, 2018 updated by: Göran Petersson

Motivational Interviewing and Medication Review in the Secondary Prevention of Coronary Heart Disease

Low medication adherence in patients with coronary heart disease increases mortality.

This study investigates if an intervention of medication review and counselling can improve patients' medication adherence and treatment results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will investigate the effects of medication review and Motivational Interviewing (MI) on patients with Coronary Heart Disease (CHD). Clinical pharmacists competent in MI and cardiology will conduct medication interviews and medication reviews at the outpatient clinic. The intervention will continue during 9 months, with interviews and reviews as needed.

Follow-up of results will take place 16 months after inclusion (corresponding to 4 months after the end of intervention).

The MI-Component will be quality assured by MITI 4.2-coding (Motivational Interviewing Treatment Integrity). The study will investigate effects on clinical outcomes, medication adherence, patients´ beliefs about medicines and quality of life.

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Kalmar, Sweden, 39182
        • Kalmar County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted for angiography
  • Verified Coronary Artery Disease (ICD-10 I20-I21)
  • Planned for follow up at the out-patient clinic (standard treatment)
  • Swedish speaking

Exclusion Criteria:

  • Cognitive impairment or any othe condition making interview or phone calls impossible.
  • Non-participation in the standard follow-up
  • Prior participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MI and Medication review
The intervention starts three months post-discharge after the standard treatment at the out-patients clinic. A medication review focused on cardiovascular drugs, and a counselling session with a clinical pharmacist using Motivational Interviewing (MI)-approach, and a follow-up phone call two weeks later. For patients with negative beliefs about medicines, three additional MI-sessions in clinic or by phone are planned together with the patient. Irrespective of beliefs the intervention ends with a second medication review and counselling session, which is coordinated with the 12-months post-discharge follow-up in primary care.
Behavioral: Standard Treatment
Behavioral: MI and Medication review
Active Comparator: Standard treatment
Standard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months.
Behavioral: Standard Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C)
Time Frame: 16 months
According to Swedish guidelines the goal is < 1,8mmol/L or at least 50% reduction from baseline.
16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients adherent to cholesterol lowering treatment
Time Frame: 16 months
Self-reported adherence according to Morisky-8-Item Adherence Scale
16 months
Percentage of patients adherent to cholesterol lowering treatment
Time Frame: 16 months
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
16 months
Percentage of patients adherent to cholesterol lowering treatment
Time Frame: 16 months
Prescription refill according to the Swedish Prescribed Drug Register, Percent Day Covered (PDC) during follow-up period, 80% is set as the cut-off for adherence.
16 months
Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)
Time Frame: 16 months
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
16 months
Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)
Time Frame: 16 months
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
16 months
Percentage of patients adherent to preventive medication: P2Y12-antagonist
Time Frame: 16 months
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
16 months
Percentage of patients adherent to preventive medication: Beta-blocker
Time Frame: 16 months
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
16 months
Percentage of patients with Systolic Blood Pressure <140
Time Frame: 16 months
As registered in the Electronic Health Record
16 months
Changes in Quality of Life
Time Frame: 16 months
The Heart QoL instrument
16 months
Number of Cardiovascular Re-admissions and Emergency Department visits
Time Frame: 16 months
According to the Health Care register of Kalmar County
16 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process measure: Quality of prescribing, for a random sample of 20 % of patients
Time Frame: 6 months
According to Medication Assessment Tool for secondary prevention of Coronary Heart disease
6 months
Process measure: What was delivered in the Medication review
Time Frame: 12 months, only intervention group
Number and type of drug-related problems, as categorized by Cipolle and Strand. And documented effects of any actions taken on drug-related problems.
12 months, only intervention group
Process measure: Quality of MI, for a random sample of 20 % of consultations
Time Frame: 12 months
According to MITI 4.2.1
12 months
Process measure: Beliefs about medicines - percent of patients per category
Time Frame: 16 months
Beliefs about medicines questionnaire (BMQ-S10), categories: accepting, ambivalent, neutral, skeptical. Also temporal cahnges in both Groups and Changes in each item of the subscales.
16 months
Process measure: Intervention experienced by patients
Time Frame: 12 months
Qualitative interview study of 8-15 patients with negative beliefs about medicines at baseline. Analyzed with content analysis.
12 months
Process measure: How did the intervention affect patients´overall experience of their follow-up care after CHD.
Time Frame: 16 months, for the last 100 patients to be included.
Open question: What is you opinion of the follow-up care after your heart disease?" Analysed with qualitative content analysis separetly for Control and intervention group patients.
16 months, for the last 100 patients to be included.
Health economic evaluation: Costs of intervention related to costs saved and Quality-adjusted Life years
Time Frame: 16 months
Quality adjusted life years estimated by the re-admissions and quality of Life using Euroqol EQ-5D-5L
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göran Petersson

Collaborators

The Kamprad Family Foundation for Entrepreneurship, Research & Charity

Investigators

  • Principal Investigator: Göran Petersson, MD, PhD, Linnaeus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLAS-1-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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