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

Primary Purpose

Coronary Heart Disease

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

PBL in patient education

Mailed patient information

About this trial

This is an interventional supportive care trial for Coronary Heart Disease focused on measuring 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.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of social and welfare studies, Linköping UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PBL- patient education

Mailed patient information

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01462799

First Posted

October 24, 2011

Last Updated

October 27, 2011

Sponsor

Linkoeping University

Collaborators

Swedish Heart Lung Foundation, Ostergotland County Council, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT01462799

Brief Title

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

Acronym

CORPRIM

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

March 2015 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Linkoeping University

Collaborators

Swedish Heart Lung Foundation, Ostergotland County Council, Sweden

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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.

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PBL- patient education

Arm Type

Experimental

Arm Description

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

Arm Title

Mailed patient information

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

PBL in patient education

Intervention Description

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

Intervention Name(s)

Mailed patient information

Intervention Description

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

Primary Outcome Measure Information:

Title

The primary-endpoint is empowerment to reach self-care goals after 5 years

Description

Focus on empowerment to reach self-care goals will be in general, healthy food, physical activity

Time Frame

At baseline and after 5 years

Secondary Outcome Measure Information:

Title

Self-efficacy to reach self-care goals after 1 year of patient education

Description

Time Frame

At baseline- and after 1, 3 and 5 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anita M, Ch Kärner, PhD

Phone

+46 (0)11 363506

anita.karner@liu.se

Facility Information:

Facility Name

Department of social and welfare studies, Linköping University

City

Norrköping

ZIP/Postal Code

601 74

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anita M, CH Kärner, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

32795267

Citation

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.

Results Reference

derived

PubMed Identifier

29843619

Citation

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.

Results Reference

derived

PubMed Identifier

23164044

Citation

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.

Results Reference

derived

Learn more about this trial

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

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