NCT02102503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

4.4 years

First QC Date

March 31, 2014

Last Update Submit

August 8, 2018

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C)

    According to Swedish guidelines the goal is \< 1,8mmol/L or at least 50% reduction from baseline.

    16 months

Secondary Outcomes (10)

  • Percentage of patients adherent to cholesterol lowering treatment

    16 months

  • Percentage of patients adherent to cholesterol lowering treatment

    16 months

  • Percentage of patients adherent to cholesterol lowering treatment

    16 months

  • Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)

    16 months

  • Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)

    16 months

  • +5 more secondary outcomes

Other Outcomes (7)

  • Process measure: Quality of prescribing, for a random sample of 20 % of patients

    6 months

  • Process measure: What was delivered in the Medication review

    12 months, only intervention group

  • Process measure: Quality of MI, for a random sample of 20 % of consultations

    12 months

  • +4 more other outcomes

Study Arms (2)

MI and Medication review

EXPERIMENTAL

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 TreatmentBehavioral: MI and Medication review

Standard treatment

ACTIVE COMPARATOR

Standard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months.

Behavioral: Standard Treatment

Interventions

Standard TreatmentBEHAVIORAL
MI and Medication reviewStandard treatment
MI and Medication reviewBEHAVIORAL
MI and Medication review

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalmar County Hospital

Kalmar, 39182, Sweden

Location

Related Publications (2)

  • Ostbring MJ, Eriksson T, Petersson G, Hellstrom L. Effects of a pharmaceutical care intervention on clinical outcomes and patient adherence in coronary heart disease: the MIMeRiC randomized controlled trial. BMC Cardiovasc Disord. 2021 Aug 1;21(1):367. doi: 10.1186/s12872-021-02178-0.

    PMID: 34334142DERIVED

  • Ostbring MJ, Eriksson T, Petersson G, Hellstrom L. Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on Clinical Outcomes, Adherence, and Quality of Life. JMIR Res Protoc. 2018 Feb 20;7(2):e57. doi: 10.2196/resprot.8659.

    PMID: 29463490DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Medication Review

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Göran Petersson, MD, PhD

    Linnaeus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Health Informatics with focus on Pharmaceutical Science

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

October 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations

SE(1)