COPDPRIMAIRNCT02213809
Case Method Education on COPD to General Practitioners
A study testing Case method education in COPD and Traditional education in COPD in people with COPD, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- Case method education in COPD and Traditional education in COPD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 822 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2014to 12 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Family Medicine, NVS, Karolinska Institutet
Huddinge, 141 83
About this study
Official title: Effect of Case Method Education to General Practitioners on Their Knowledge on COPD and on the Health of Their Patients With COPD
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.
Read more
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.
- Conditions
- COPD
- Being tested
- Case method education in COPD, Traditional education in COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case method education in COPDBehavioural
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 COPDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Case method education in COPD | Experimental | Two hours of case method education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers. The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education. Receives: Behavioral: Case method education in COPD |
| Traditional education in COPD | Active comparator | Two hours of traditional education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers.The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education. Receives: Behavioral: Traditional education in COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1-2 months before the intervention and 18 months after the intervention
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.
Measured: Immediately before the intervention and 12 months later.
Secondary outcomes (2)
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.
Measured: 1-2 months before the intervention and 18 months after the intervention
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.
Measured: 1-2 months before the intervention and 18 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study start16 Oct 2014
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Dalarna County Council, Sweden
- Responsible party
- Principal investigator, Anna Nager, Karolinska Institutet
- Investigators
- Anna Nager, PhD, Principal investigator, Karolinska InstitutetHanna Sandelowsky, MD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213809
- Sponsor's protocol ID
- 2013/232-31/5
- Acronym
- PRIMAIR
- Status last verified
- Jan 2023
- First submitted
- 8 Aug 2014
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Sandelowsky H, Krakau I, Modin S, Stallberg B, Nager A. Primary care patients with mild or stable chronic obstructive pulmonary disease need more support in disease management: a secondary analysis of a cluster randomized controlled trial. Scand J Prim Health Care. 2023 Dec;41(4):495-504. doi: 10.1080/02813432.2023.2280039. Epub 2023 Nov 29.
PubMed 37975839Sandelowsky H, Krakau I, Modin S, Stallberg B, Johansson SE, Nager A. Effectiveness of traditional lectures and case methods in Swedish general practitioners' continuing medical education about COPD: a cluster randomised controlled trial. BMJ Open. 2018 Aug 10;8(8):e021982. doi: 10.1136/bmjopen-2018-021982.
PubMed 30099398Sandelowsky H, Krakau I, Modin S, Stallberg B, Nager A. Case Method in COPD education for primary care physicians: study protocol for a cluster randomised controlled trial. Trials. 2017 Apr 27;18(1):197. doi: 10.1186/s13063-017-1889-4.
PubMed 28449709
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Case Method Education to General Practitioners on Their Knowledge on COPD and on the Health of Their Patients With COPD
- ClinicalTrials.gov ID
- NCT02213809
- Acronym / sponsor ID
- PRIMAIR / 2013/232-31/5
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 822 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Dalarna County Council, Sweden
- Study start
- 16 Oct 2014 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case method education in COPD | Experimental | Behavioral: Case method education in COPDTwo hours of case method education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers. The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education. |
| Traditional education in COPD | Active comparator | Behavioral: Traditional education in COPDTwo hours of traditional education in COPD are given two times within 3 months to the general practitioners at nine primary health care centers.The education covers examination, including interpretation av spirometry, and treatment of patients with COPD. The learning outcomes are predefined and are the same in both arms. The same person will teach at both times of education. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case method education in COPDIn 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. | Behavioural | Case method education in COPD |
| Traditional education in COPDTraditional 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. | Behavioural | Traditional education in COPD |
Primary outcome
Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later.
Time frame: 1-2 months before the intervention and 18 months after the intervention
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).
Difference in questionnaire about knowledge in COPD (questionnaire created by the research group)among the general practitioners that receive the education.
Time frame: Immediately before the intervention and 12 months later.
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.
2 secondary outcomes
Difference i patients' assessment of Lung Information Needs Questionnaire (LINQ) before the intervention and 18 months later.
Time frame: 1-2 months before the intervention and 18 months after the intervention
Difference in patients' assessment of COPD Assessment Test (CAT) before the intervention and 18 months later.
Time frame: 1-2 months before the intervention and 18 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 37975839Sandelowsky H, Krakau I, Modin S, Stallberg B, Nager A. Primary care patients with mild or stable chronic obstructive pulmonary disease need more support in disease management: a secondary analysis of a cluster randomized controlled trial. Scand J Prim Health Care. 2023 Dec;41(4):495-504. doi: 10.1080/02813432.2023.2280039. Epub 2023 Nov 29.
- Derived from this study: PubMed 30099398Sandelowsky H, Krakau I, Modin S, Stallberg B, Johansson SE, Nager A. Effectiveness of traditional lectures and case methods in Swedish general practitioners' continuing medical education about COPD: a cluster randomised controlled trial. BMJ Open. 2018 Aug 10;8(8):e021982. doi: 10.1136/bmjopen-2018-021982.
- Derived from this study: PubMed 28449709Sandelowsky H, Krakau I, Modin S, Stallberg B, Nager A. Case Method in COPD education for primary care physicians: study protocol for a cluster randomised controlled trial. Trials. 2017 Apr 27;18(1):197. doi: 10.1186/s13063-017-1889-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Nager, PhD principal investigator
Karolinska Institutet
Hanna Sandelowsky, MD study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case method education in COPD and Traditional education in COPD in people with COPD, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference i patients' assessment of Clinical COPD Questionnaire (CCQ) before the intervention and 18 months later. (time frame: 1-2 months before the intervention and 18 months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02213809, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.