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

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ClinicalTrials.gov Identifier: NCT02102503
Recruitment Status : Active, not recruiting
First Posted : April 3, 2014
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
The Kamprad Family Foundation for Entrepreneurship, Research and Charity
Information provided by (Responsible Party):
Göran Petersson, Linneaus University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Coronary Heart Disease Behavioral: Standard Treatment Behavioral: MI and Medication review Not Applicable

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  (Clinical Trial)
Actual Enrollment : 417 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Motivational Interviewing and Medication Review in the Secondary Prevention of Coronary Heart Disease
Study Start Date : October 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of patients adherent to cholesterol lowering treatment [ Time Frame: 16 months ]
    Self-reported adherence according to Morisky-8-Item Adherence Scale

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Percentage of patients with Systolic Blood Pressure <140 [ Time Frame: 16 months ]
    As registered in the Electronic Health Record

  9. Changes in Quality of Life [ Time Frame: 16 months ]
    The Heart QoL instrument

  10. Number of Cardiovascular Re-admissions and Emergency Department visits [ Time Frame: 16 months ]
    According to the Health Care register of Kalmar County


Other Outcome Measures:
  1. 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

  2. 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.

  3. Process measure: Quality of MI, for a random sample of 20 % of consultations [ Time Frame: 12 months ]
    According to MITI 4.2.1

  4. 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.

  5. 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.

  6. 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.

  7. 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



Information from the National Library of Medicine

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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:

  • 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

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): NCT02102503


Locations
Sweden
Kalmar County Hospital
Kalmar, Sweden, 39182
Sponsors and Collaborators
Göran Petersson
The Kamprad Family Foundation for Entrepreneurship, Research and Charity
Investigators
Principal Investigator: Göran Petersson, MD, PhD Linneaus University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göran Petersson, Professor of Health Informatics with focus on Pharmaceutical Science, Linneaus University
ClinicalTrials.gov Identifier: NCT02102503     History of Changes
Other Study ID Numbers: GLAS-1-2013
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases