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

Not Applicable

• Conditions: Coronary Heart Disease
• Interventions: Behavioral: PBL in patient education; Behavioral: Mailed patient information

• Registration Number: NCT01462799
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2011-09
• Status Verified: 2011-10
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-27
• Last Update Submitted: 2011-10-27
• Study First Posted: 2011-10-31
• Last Update Posted: 2011-10-31
• Primary Completion: 2015-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBL- patient education	PBL in patient education	Patients will be randomised to PBL in patient education (experiment group)
PBL- patient education	Mailed patient information	Patients will be randomised to PBL in patient education (experiment group)
Mailed patient information	Mailed patient information	Patients will be randomised to controlgroup receiving mailed patient information during the year

Primary Outcome Measures

Name	Time	Method
The primary-endpoint is empowerment to reach self-care goals after 5 years	At baseline and after 5 years	Focus on empowerment to reach self-care goals will be in general, healthy food, physical activity

Secondary Outcome Measures

Name	Time	Method
Self-efficacy to reach self-care goals after 1 year of patient education	At baseline- and after 1, 3 and 5 years	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

Trial Locations

Locations (1)

Department of social and welfare studies, Linköping University; 🇸🇪 Norrköping, Sweden