NCT01462799

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2011

Enrollment Period

3.5 years

First QC Date

October 24, 2011

Last Update Submit

October 27, 2011

Conditions

Coronary Heart Disease

Keywords

PBLpatient educationcoronary heart diseaseempowermentself-efficacyself-careFocus 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.

Outcome Measures

Primary Outcomes (1)

  • 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

    At baseline and after 5 years

Secondary Outcomes (1)

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

    At baseline- and after 1, 3 and 5 years

Study Arms (2)

PBL- patient education

EXPERIMENTAL

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

Behavioral: PBL in patient educationBehavioral: Mailed patient information

Mailed patient information

EXPERIMENTAL

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

Behavioral: Mailed patient information

Interventions

PBL in patient educationBEHAVIORAL

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.

PBL- patient education
Mailed patient informationBEHAVIORAL

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

Mailed patient informationPBL- patient education

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of social and welfare studies, Linköping University

Norrköping, 601 74, Sweden

RECRUITING

Related Publications (4)

  • 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.

    PMID: 36828650DERIVED

  • 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.

    PMID: 32795267DERIVED

  • 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.

    PMID: 29843619DERIVED

  • 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.

    PMID: 23164044DERIVED

MeSH Terms

Conditions

Coronary DiseaseEmpowerment

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Anita M, Ch Kärner, PhD

CONTACT

+46 (0)11 363506anita.karner@liu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Lecturer

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 31, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2019

Last Updated

October 31, 2011

Record last verified: 2011-10

Locations

SE(1)