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COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care

NCT ID: NCT01462799

Last Updated: 2011-10-31

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2019-03-31

Brief Summary

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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

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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

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Coronary Heart Disease

Keywords

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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 Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PBL- patient education

Patients will be randomised to PBL in patient education (experiment group)

Group Type EXPERIMENTAL

PBL in patient education

Intervention Type BEHAVIORAL

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 information

Intervention Type BEHAVIORAL

During the study year patients in this control group will receive mailed patient information about life style changes.

Mailed patient information

Patients will be randomised to controlgroup receiving mailed patient information during the year

Group Type EXPERIMENTAL

Mailed patient information

Intervention Type BEHAVIORAL

During the study year patients in this control group will receive mailed patient information about life style changes.

Interventions

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PBL in patient education

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.

Intervention Type BEHAVIORAL

Mailed patient information

During the study year patients in this control group will receive mailed patient information about life style changes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Heart Lung Foundation

OTHER

Sponsor Role collaborator

Ostergotland County Council, Sweden

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Anita Karner

University Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of social and welfare studies, Linköping University

Norrköping, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Anita M, Ch Kärner, PhD

Role: CONTACT

Phone: +46 (0)11 363506

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 36828650 (View on PubMed)

Kohler 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.

Reference Type DERIVED
PMID: 32795267 (View on PubMed)

Karner 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.

Reference Type DERIVED
PMID: 29843619 (View on PubMed)

Karner 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.

Reference Type DERIVED
PMID: 23164044 (View on PubMed)

Other Identifiers

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COR-PRIM-Dnr 2010/128-3

Identifier Type: -

Identifier Source: org_study_id