Coronary Heart DiseaseCORPRIMNCT01462799
COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care
A study testing PBL in patient education and Mailed patient information in people with Coronary Heart Disease, run by Linkoeping University at 1 site in Sweden.
Trial summary
The hypothesis is that problem based learning (PBL) in patient education positively affects self-care agency of lifestyle changes after an event of coronary heart disease (CHD). The investigators therefore aim to determine whether long-term follow-up in primary health care in patient education involving PBL affects… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- PBL in patient education and Mailed patient information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Mar 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of all ages with CHD verified by MI and/or Percutaneous Coronary Intervention (PCI) and/or coronary artery by-pass surgery (CABG) within 12 months before planned start of the intervention.
- Patients should be stable regarding their cardiac conditions and have optimised cardiac medication not substantially changed during the last month, completed heart school in hospital care (if applicable), listed at one of five specific primary health care centres agreed to join the project at time of inclusion.
Who cannot join
- Planned CABG or other causes demanding continued cardiologist care; e.g. on-going contact with heart failure clinic due to drug titration or investigations e.g. myocardial scintigraphy to detect ischemia before a new PCI
- Life expectancy ≤ 1 year, documented psychiatric disease that render difficulties to cooperate with other people or obvious abuse of alcohol or narcotics.
- Patients will also be excluded if they are unable to communicate or read the Swedish language and if they participate in other studies affecting the results.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of social and welfare studies, Linköping University
Norrköping, 601 74
Anita M, CH Kärner, PhD
About this study
Official title: COR-PRIM: Problem-based Learning in Patient Education After an Event of Coronary Heart Disease. A Randomised Study in Primary Care of Long-term Effects on Self-care
The hypothesis is that problem based learning (PBL) in patient education positively affects self-care agency of lifestyle changes after an event of coronary heart disease (CHD). The investigators therefore aim to determine whether long-term follow-up in primary health care in patient education involving PBL affects self-care behaviour in terms of patients' beliefs, self-efficacy and empowerment to make lifestyle changes. The general aim is to evaluate if PBL in patient education after CHD affects long-term self-care in relation to present lifestyle goals. Another aim of the study is to perform an economic assessment of long term effects of life style changes reached by using PBL after en event of CHD.
Read the detailed description
Even though the convincing evidence of that self-care such as regular exercise and/or stop smoking alters the course of events after an event of coronary heart disease (CHD), risk factors remain. Outcomes can improve if core components of secondary prevention programmes are structurally pedagogically applied using adult learning principles e.g. problem based learning (PBL). Until now, most education programs for patients with CHD are not based on such principles and primary health care lacks structure in the follow-up of self-care goals of the patients. All patients will receive conventional care from their general practitioner and other care providers. They will randomly be allocated to an intervention that consists of a problem based patient education program (1 year) in PHC by trained district nurses (tutors). Patients in the control group will not attend a PBL group but receive mailed patient information during the 1 year.
- Conditions
- Coronary Heart Disease
- Being tested
- PBL in patient education, Mailed patient information
- Keywords
- PBL, patient education, coronary heart disease, empowerment, self-efficacy, self-care, Focus on to determine the long term effectiveness of PBL in patient education by comparison of standardized homesent information in patients with CHD., Further focus is on patients' self-care goals, beliefs, self-efficacy and empowerment to make lifestyle changes.
- Medical subject headings
- Coronary Disease, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBL in patient educationBehavioural
The experiment group will enter a PBL patient education that is characterised by autonomous learning. The patients work together in small groups. Focus is on lifestyle changes. Starting point of learning is the patient's individual life style goals. Thirteen meetings during 1 year for 2 hours; weekly for the first month, every second week next two months and the last meetings 16, 20 and 26, 39 and 52 weeks after start. The programme shall be completed 1 year after start. The patients work with starting triggers such as pictures, texts, or concrete materials. Nurses work as tutors (after completion of a tutorial education) during the meetings using a problem based model to support patients formulate issues and goals to work with during the year. When the patients do not solve question the possibility of inviting e.g. a GP, dietician, pharmacist or physiotherapist is possible.
Mailed patient informationBehavioural
During the study year patients in this control group will receive mailed patient information about life style changes.
| Study group | Role | What they receive |
|---|---|---|
| PBL- patient education | Experimental | Patients will be randomised to PBL in patient education (experiment group) Receives: Behavioral: PBL in patient education; Behavioral: Mailed patient information |
| Mailed patient information | Experimental | Patients will be randomised to controlgroup receiving mailed patient information during the year Receives: Behavioral: Mailed patient information |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary-endpoint is empowerment to reach self-care goals after 5 years
Focus on empowerment to reach self-care goals will be in general, healthy food, physical activity
Measured: At baseline and after 5 years
Secondary outcomes (1)
Self-efficacy to reach self-care goals after 1 year of patient education
Self-efficacy (in general; physical exercise and healthy diet); well-being and changes in patients 'beliefs about self-care. New cardiovascular events, blood pressure, BMI, waist measurement, blood tests, costs will be calculated from a health care perspective. Resource use for conventional care and the interventions will be collected prospectively throughout the study. Questionnaires will be used to determine effectiveness (quality adjusted life years) and our goal is to perform a cost-utility analysis
Measured: At baseline- and after 1, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2015 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Swedish Heart Lung Foundation, Ostergotland County Council, Sweden
- Responsible party
- Principal investigator, Anita Karner, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462799
- Sponsor's protocol ID
- COR-PRIM-Dnr 2010/128-3
- Acronym
- CORPRIM
- Status last verified
- Oct 2011
- First submitted
- 24 Oct 2011
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Andreae C, Tingstrom P, Nilsson S, Jaarsma T, Karlsson N, Karner Kohler A. Does problem-based learning improve patient empowerment and cardiac risk factors in patients with coronary heart disease in a Swedish primary care setting? A long-term prospective, randomised, parallel single randomised trial (COR-PRIM). BMJ Open. 2023 Feb 24;13(2):e065230. doi: 10.1136/bmjopen-2022-065230.
PubMed 36828650Kohler AK, Jaarsma T, Tingstrom P, Nilsson S. The effect of problem-based learning after coronary heart disease - a randomised study in primary health care (COR-PRIM). BMC Cardiovasc Disord. 2020 Aug 14;20(1):370. doi: 10.1186/s12872-020-01647-2.
PubMed 32795267Karner Kohler A, Tingstrom P, Jaarsma T, Nilsson S. Patient empowerment and general self-efficacy in patients with coronary heart disease: a cross-sectional study. BMC Fam Pract. 2018 May 30;19(1):76. doi: 10.1186/s12875-018-0749-y.
PubMed 29843619Karner A, Nilsson S, Jaarsma T, Andersson A, Wirehn AB, Wodlin P, Hjelmfors L, Tingstrom P. The effect of problem-based learning in patient education after an event of CORONARY heart disease--a randomised study in PRIMARY health care: design and methodology of the COR-PRIM study. BMC Fam Pract. 2012 Nov 20;13:110. doi: 10.1186/1471-2296-13-110.
PubMed 23164044
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COR-PRIM: Problem-based Learning in Patient Education After an Event of Coronary Heart Disease. A Randomised Study in Primary Care of Long-term Effects on Self-care
- ClinicalTrials.gov ID
- NCT01462799
- Acronym / sponsor ID
- CORPRIM / COR-PRIM-Dnr 2010/128-3
- Conditions
- Coronary Heart Disease
- Keywords
- PBL, patient education, coronary heart disease, empowerment, self-efficacy, self-care, Focus on to determine the long term effectiveness of PBL in patient education by comparison of standardized homesent information in patients with CHD., Further focus is on patients' self-care goals, beliefs, self-efficacy and empowerment to make lifestyle changes.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Swedish Heart Lung Foundation, Ostergotland County Council, Sweden
- Study start
- Sep 2011
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 31 Oct 2011 (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.
The hypothesis is that problem based learning (PBL) in patient education positively affects self-care agency of lifestyle changes after an event of coronary heart disease (CHD). The investigators therefore aim to determine whether long-term follow-up in primary health care in patient education involving PBL affects self-care behaviour in terms of patients' beliefs, self-efficacy and empowerment to make lifestyle changes. The general aim is to evaluate if PBL in patient education after CHD affects long-term self-care in relation to present lifestyle goals. Another aim of the study is to perform an economic assessment of long term effects of life style changes reached by using PBL after en event of CHD.
Detailed description
Even though the convincing evidence of that self-care such as regular exercise and/or stop smoking alters the course of events after an event of coronary heart disease (CHD), risk factors remain. Outcomes can improve if core components of secondary prevention programmes are structurally pedagogically applied using adult learning principles e.g. problem based learning (PBL). Until now, most education programs for patients with CHD are not based on such principles and primary health care lacks structure in the follow-up of self-care goals of the patients. All patients will receive conventional care from their general practitioner and other care providers. They will randomly be allocated to an intervention that consists of a problem based patient education program (1 year) in PHC by trained district nurses (tutors). Patients in the control group will not attend a PBL group but receive mailed patient information during the 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBL- patient education | Experimental | Behavioral: PBL in patient education, Behavioral: Mailed patient informationPatients will be randomised to PBL in patient education (experiment group) |
| Mailed patient information | Experimental | Behavioral: Mailed patient informationPatients will be randomised to controlgroup receiving mailed patient information during the year |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of all ages with CHD verified by MI and/or Percutaneous Coronary Intervention (PCI) and/or coronary artery by-pass surgery (CABG) within 12 months before planned start of the intervention.
- Patients should be stable regarding their cardiac conditions and have optimised cardiac medication not substantially changed during the last month, completed heart school in hospital care (if applicable), listed at one of five specific primary health care centres agreed to join the project at time of inclusion.
Key exclusion criteria (3 listed)
- Planned CABG or other causes demanding continued cardiologist care; e.g. on-going contact with heart failure clinic due to drug titration or investigations e.g. myocardial scintigraphy to detect ischemia before a new PCI
- Life expectancy ≤ 1 year, documented psychiatric disease that render difficulties to cooperate with other people or obvious abuse of alcohol or narcotics.
- Patients will also be excluded if they are unable to communicate or read the Swedish language and if they participate in other studies affecting the results.
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 |
|---|---|---|
| PBL in patient educationThe experiment group will enter a PBL patient education that is characterised by autonomous learning. The patients work together in small groups. Focus is on lifestyle changes. Starting point of learning is the patient's individual life style goals. Thirteen meetings during 1 year for 2 hours; weekly for the first month, every second week next two months and the last meetings 16, 20 and 26, 39 and 52 weeks after start. The programme shall be completed 1 year after start. The patients work with starting triggers such as pictures, texts, or concrete materials. Nurses work as tutors (after completion of a tutorial education) during the meetings using a problem based model to support patients formulate issues and goals to work with during the year. When the patients do not solve question the possibility of inviting e.g. a GP, dietician, pharmacist or physiotherapist is possible. | Behavioural | PBL- patient education |
| Mailed patient informationDuring the study year patients in this control group will receive mailed patient information about life style changes. | Behavioural | Mailed patient information, PBL- patient education |
Primary outcome
The primary-endpoint is empowerment to reach self-care goals after 5 years
Time frame: At baseline and after 5 years
Focus on empowerment to reach self-care goals will be in general, healthy food, physical activity
1 secondary outcome
Self-efficacy to reach self-care goals after 1 year of patient education
Time frame: At baseline- and after 1, 3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2011.
- Derived from this study: PubMed 36828650Andreae C, Tingstrom P, Nilsson S, Jaarsma T, Karlsson N, Karner Kohler A. Does problem-based learning improve patient empowerment and cardiac risk factors in patients with coronary heart disease in a Swedish primary care setting? A long-term prospective, randomised, parallel single randomised trial (COR-PRIM). BMJ Open. 2023 Feb 24;13(2):e065230. doi: 10.1136/bmjopen-2022-065230.
- Derived from this study: PubMed 32795267Kohler AK, Jaarsma T, Tingstrom P, Nilsson S. The effect of problem-based learning after coronary heart disease - a randomised study in primary health care (COR-PRIM). BMC Cardiovasc Disord. 2020 Aug 14;20(1):370. doi: 10.1186/s12872-020-01647-2.
- Derived from this study: PubMed 29843619Karner Kohler A, Tingstrom P, Jaarsma T, Nilsson S. Patient empowerment and general self-efficacy in patients with coronary heart disease: a cross-sectional study. BMC Fam Pract. 2018 May 30;19(1):76. doi: 10.1186/s12875-018-0749-y.
- Derived from this study: PubMed 23164044Karner A, Nilsson S, Jaarsma T, Andersson A, Wirehn AB, Wodlin P, Hjelmfors L, Tingstrom P. The effect of problem-based learning in patient education after an event of CORONARY heart disease--a randomised study in PRIMARY health care: design and methodology of the COR-PRIM study. BMC Fam Pract. 2012 Nov 20;13:110. doi: 10.1186/1471-2296-13-110.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBL in patient education and Mailed patient information in people with Coronary Heart Disease, run by Linkoeping University 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 2 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: status not confirmed, as of the sponsor's last update on 31 Oct 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anita M, Ch Kärner, PhD (+46 (0)11 363506, anita.karner@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary-endpoint is empowerment to reach self-care goals after 5 years (time frame: At baseline and after 5 years). 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 NCT01462799, which also lists 4 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 31 Oct 2011; AzTrials last refreshed its copy on 28 Oct 2026.