Clinical trial NCT01462799: COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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.
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Swedish Heart Lung Foundation
name: Ostergotland County Council, Sweden
First posted: 2011-10-31
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The primary-endpoint is empowerment to reach self-care goals after 5 years
timeFrame: At baseline and after 5 years
Secondary outcomes:
measure: Self-efficacy to reach self-care goals after 1 year of patient education
timeFrame: At baseline- and after 1, 3 and 5 years
Other outcomes:
Locations:
city: Norrköping
country: Sweden
facility: Department of social and welfare studies, Linköping University
Study officials:
References:
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.
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.
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.