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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02213809
Other study ID # 2013/232-31/5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2014
Est. completion date December 12, 2018

Study information

Verified date January 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: COPD is an inflammatory and chronic obstructive lung disease, mainly caused by smoking. Most patients with COPD are discovered and treated in primary health care. Co-morbidity with heart disease, hypertension, diabetes, osteoporosis and underweight is common. It is important to diagnose COPD at an early stage, primarily to motivate smoking cessation, which is the most important factor for decelerating the progress of COPD. In addition, medication and rehabilitation to reduce symptoms of COPD can be given. Previous studies in Sweden have shown poor quality of primary health care provided to patients with COPD. As general practitioners often deal with multiple medical problems and patients' motivation when diagnosing and treating COPD we hypothesize that case method education (see description under "intervention") in COPD has better effect than traditional education (see description under "intervention").This study aims to examine the effect of case method education on (1) learning in COPD among general practitioners and on (2) health in their patients with COPD. Method: Primary health care centers (PHCC) in Stockholm will be recruited. The PHCCs will be randomized to either case method education (n=9 PHCCs) or traditional education (n=9 PHCCs) in COPD for their general practitioners. The educations will be held during two times (two hours each) within a time range of three months, covering examination and treatment of patients with COPD. At least 10.000 patients should be listed at PHCCs included. Random sampling of 45 patients with COPD at stage 2-3 will be done from each PHCC. The patients will fill in a self-assessment questionnaire including CCQ, CAT and LINQ (see outcome measures) as well as questions about medication, exacerbations and other chronic diseases. The questionnaire will be sent to the patients 1-2 months before the education and 18 months after the education. Differences in assessments in the questionnaire before and after the education will be compared between the patients listed at the PHCCs that have received case method education vs. traditional education. In addition, general practitioners (approximately, n=180) at the PHCCs will fill in a questionnaire, immediately before and 12 months after the education, covering the learning outcomes in order to study differences in learning between the two intervention groups.


Recruitment information / eligibility

Status Completed
Enrollment 822
Est. completion date December 12, 2018
Est. primary completion date December 12, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Primary Health Care Centers (PHCC): >10.000 patients listed. >70% permanent employed general practitioners - Patients: Diagnosis of COPD registered at the COPD. Grade of COPD 2-3 (GOLD) at the latest spirometry completed since 2008. Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Case method education in COPD
In case method a rich narrative describing of a real-life situation (teaching case) is presented, in which the learning group must make a decision or solve a problem. The teaching case provide information, but neither analysis nor conclusions. The analytical work of explaining the relationships among events in the case, identifying options, evaluating choices and predicting the effects of actions is the work done by students during the discussion.
Traditional education in COPD
Traditional education in this study means that the teacher mainly speaks to the group. Although short cases may be used for illustration, the main focus is not that the group shall solve problems from a narrative case.

Locations

Country Name City State
Sweden Department of Family Medicine, NVS, Karolinska Institutet Huddinge

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Dalarna County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later. The CCQ measures health status in patients with COPD and consists of 10 items with an overall score and 3 domains: Symptoms (4 items), Functional state (4 items) and Mental state (2 items). All scores range from 0 to 6; (0 = no impairment). 1-2 months before the intervention and 18 months after the intervention
Primary Difference in questionnaire about knowledge in COPD (questionnaire created by the research group)among the general practitioners that receive the education. The questionnaire covers examination and treatment of COPD and includes multiple choice questions as well as questions about attitudes that will be answered in free text. Immediately before the intervention and 12 months later.
Secondary Difference i patients' assessment of Lung Information Needs Questionnaire (LINQ) before the intervention and 18 months later. LINQ measures patients perceptions about COPD and what information about COPD patients think that they have percieved from health care personnel. 1-2 months before the intervention and 18 months after the intervention
Secondary Difference in patients' assessment of COPD Assessment Test (CAT) before the intervention and 18 months later. The COPD Assessment Test (CAT) measures the impact of COPD on a person's life. 1-2 months before the intervention and 18 months after the intervention
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