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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by Linkoeping University
Sponsor:
Collaborators:
Swedish Heart and Lung Assoc.
Ostergotland County Council, Sweden
Information provided by (Responsible Party):
Anita Karner, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01462799
First received: October 24, 2011
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Behavioral: PBL in patient education
Behavioral: Mailed patient information

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • The primary-endpoint is empowerment to reach self-care goals after 5 years [ Time Frame: At baseline and after 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: At baseline- and after 1, 3 and 5 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PBL- patient education
Patients will be randomised to PBL in patient education (experiment group)
Behavioral: 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.
Behavioral: Mailed patient information
During the study year patients in this control group will receive mailed patient information about life style changes.
Experimental: Mailed patient information
Patients will be randomised to controlgroup receiving mailed patient information during the year
Behavioral: Mailed patient information
During the study year patients in this control group will receive mailed patient information about life style changes.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462799

Contacts
Contact: Anita M, Ch Kärner, PhD +46 (0)11 363506 anita.karner@liu.se

Locations
Sweden
Department of social and welfare studies, Linköping University Recruiting
Norrköping, Sweden, 601 74
Principal Investigator: Anita M, CH Kärner, PhD         
Sponsors and Collaborators
Linkoeping University
Swedish Heart and Lung Assoc.
Ostergotland County Council, Sweden
  More Information

No publications provided by Linkoeping University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anita Karner, University Lecturer, Linkoeping University
ClinicalTrials.gov Identifier: NCT01462799     History of Changes
Other Study ID Numbers: COR-PRIM-Dnr 2010/128-3
Study First Received: October 24, 2011
Last Updated: October 27, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
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.

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014