Coronary Heart DiseaseMIMeRiCNCT02102503
Motivational Interviewing and Medication Review in Coronary Heart Disease
A study testing Standard Treatment and MI and Medication review in people with Coronary Heart Disease, run by Göran Petersson at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Standard Treatment and MI and Medication review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted for angiography
- Verified Coronary Artery Disease (ICD-10 I20-I21)
- Planned for follow up at the out-patient clinic (standard treatment)
- Swedish speaking
Who cannot join
- Cognitive impairment or any othe condition making interview or phone calls impossible.
- Non-participation in the standard follow-up
- Prior participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Standard Treatment, MI and Medication review
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TreatmentBehavioural
MI and Medication reviewBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Standard Treatment; Behavioral: 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. Receives: Behavioral: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 months
Secondary outcomes (10)
Percentage of patients adherent to cholesterol lowering treatment
Self-reported adherence according to Morisky-8-Item Adherence Scale
Measured: 16 months
Percentage of patients adherent to cholesterol lowering treatment
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Measured: 16 months
Percentage of patients adherent to cholesterol lowering treatment
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.
Measured: 16 months
Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Measured: 16 months
Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Measured: 16 months
Percentage of patients adherent to preventive medication: P2Y12-antagonist
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Measured: 16 months
Percentage of patients adherent to preventive medication: Beta-blocker
Prescription refill according to the Swedish Prescribed Drug Register, 1 refill month 12-16 is set as the cut-off for adherence.
Measured: 16 months
Percentage of patients with Systolic Blood Pressure <140
As registered in the Electronic Health Record
Measured: 16 months
Changes in Quality of Life
The Heart QoL instrument
Measured: 16 months
Number of Cardiovascular Re-admissions and Emergency Department visits
According to the Health Care register of Kalmar County
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göran Petersson
- Sponsor type
- University, hospital or other
- Collaborators
- The Kamprad Family Foundation for Entrepreneurship, Research & Charity
- Responsible party
- Sponsor-investigator, Göran Petersson, Linnaeus University
- Investigators
- Göran Petersson, MD, PhD, Principal investigator, Linnaeus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102503
- Sponsor's protocol ID
- GLAS-1-2013
- Acronym
- MIMeRiC
- Status last verified
- Aug 2018
- First submitted
- 31 Mar 2014
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ostbring MJ, Al Musawi A, Eriksson T, Hellstrom L. Impact of a pharmacist adherence intervention on medication beliefs and drug-related problems in coronary patients - a process evaluation of the MIMeRiC trial. BMC Health Serv Res. 2026 Sep 15;26(1):1283. doi: 10.1186/s12913-026-15037-5.
PubMed 42760559Ostbring 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.
PubMed 34334142Ostbring 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.
PubMed 29463490
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing and Medication Review in the Secondary Prevention of Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT02102503
- Acronym / sponsor ID
- MIMeRiC / GLAS-1-2013
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Göran PeterssonUniversity, hospital or other
- Collaborators
- The Kamprad Family Foundation for Entrepreneurship, Research & Charity
- Study start
- Oct 2013
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI and Medication review | Experimental | Behavioral: Standard Treatment, Behavioral: MI and Medication reviewThe 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. |
| Standard treatment | Active comparator | Behavioral: Standard TreatmentStandard treatment at the cardiology out-patient clinic. Follow-up by nurse after two weeks and by physician after two months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted for angiography
- Verified Coronary Artery Disease (ICD-10 I20-I21)
- Planned for follow up at the out-patient clinic (standard treatment)
- Swedish speaking
Key exclusion criteria (3 listed)
- Cognitive impairment or any othe condition making interview or phone calls impossible.
- Non-participation in the standard follow-up
- Prior participation in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Treatment | Behavioural | MI and Medication review, Standard treatment |
| MI and Medication review | Behavioural | MI and Medication review |
Primary outcome
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.
10 secondary outcomes
Percentage of patients adherent to cholesterol lowering treatment
Time frame: 16 months
Percentage of patients adherent to cholesterol lowering treatment
Time frame: 16 months
Percentage of patients adherent to cholesterol lowering treatment
Time frame: 16 months
Percentage of patients adherent to preventive medication: Angiotensin Converter Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)
Time frame: 16 months
Percentage of patients adherent to preventive medication: Acetylsalicylic acid (ASA)
Time frame: 16 months
Percentage of patients adherent to preventive medication: P2Y12-antagonist
Time frame: 16 months
Percentage of patients adherent to preventive medication: Beta-blocker
Time frame: 16 months
Percentage of patients with Systolic Blood Pressure <140
Time frame: 16 months
Changes in Quality of Life
Time frame: 16 months
Number of Cardiovascular Re-admissions and Emergency Department visits
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 42760559Ostbring MJ, Al Musawi A, Eriksson T, Hellstrom L. Impact of a pharmacist adherence intervention on medication beliefs and drug-related problems in coronary patients - a process evaluation of the MIMeRiC trial. BMC Health Serv Res. 2026 Sep 15;26(1):1283. doi: 10.1186/s12913-026-15037-5.
- Derived from this study: PubMed 34334142Ostbring 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.
- Derived from this study: PubMed 29463490Ostbring 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Göran Petersson, MD, PhD principal investigator
Linnaeus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Treatment and MI and Medication review in people with Coronary Heart Disease, run by Göran Petersson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who achieve the treatment goal for Low density lipoprotein cholesterol (LDL-C) (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102503, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.