Motivational Interviewing and Medication Review in Coronary Heart Disease

NCT ID: NCT02102503

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Standard Treatment

Intervention Type BEHAVIORAL

MI and Medication review

Intervention Type BEHAVIORAL

Standard treatment

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

Group Type ACTIVE_COMPARATOR

Standard Treatment

Intervention Type BEHAVIORAL

Interventions

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Standard Treatment

Intervention Type BEHAVIORAL

MI and Medication review

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Kamprad Family Foundation for Entrepreneurship, Research & Charity

OTHER

Sponsor Role collaborator

Göran Petersson

OTHER

Sponsor Role lead

Responsible Party

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Göran Petersson

Professor of Health Informatics with focus on Pharmaceutical Science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Göran Petersson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Linnaeus University

Locations

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Kalmar County Hospital

Kalmar, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 34334142 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29463490 (View on PubMed)

Other Identifiers

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GLAS-1-2013

Identifier Type: -

Identifier Source: org_study_id

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