Health Knowledge, Attitudes, PracticeNCT01567267
Evaluation of Educational Intervention to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes
A study testing Experimental educational intervention and Standard educational intervention in people with Health Knowledge, Attitudes, Practice, run by Goethe University at 1 site in Germany.
Trial summary
The purpose of this study is to identify the effect of a short term educational intervention for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good Scientific Practice (GSP) to high-school biology students. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Experimental educational intervention and Standard educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to May 2019
- 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
- students becoming biology teachers at participating university during enrollment period
Who cannot join
- refusal to participate in study
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Siegen, Section of biology and und their didactics
Siegen, 57068
About this study
Official title: Phase II Study of a Short Term Educational Intervention for Upcoming Biology Teachers to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes at High-school
The purpose of this study is to identify the effect of a short term educational intervention for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good Scientific Practice (GSP) to high-school biology students.
Read the detailed description
Shared decision making is increasingly demanded by patients in order to take part in health care decisions. However this demand for autonomy can only be used for shared decision making if the patient has basic skills in critical health literacy. To transfer health care literacy to young and healthy consumers educational intervention programs at high-school might be a feasible and effective way. This preliminary phase 2 study is designed to investigate the effect of an educational intervention to be integrated in a curriculum for upcoming teachers in biology.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Experimental educational intervention, Standard educational intervention
- Keywords
- Evidence-based Medicine, Good Scientific Practice, Problem-based Learning, Critical health literacy, Educational intervention
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental educational interventionBehavioural
Educational intervention consisting of a 4-day-course in Evidence-based Medicine and Good Scientific Practice combined with the method of Problem-based Learning.
Standard educational interventionBehavioural
Educational intervention on the didactics of biology (4-day-course) not containing elements of Evidence-based Medicine, Good Scientific Practice or Problem-based learning.
| Study group | Role | What they receive |
|---|---|---|
| Experimental educational intervention | Experimental | Experimental educational intervention Receives: Behavioral: Experimental educational intervention |
| Standard educational intervention | Active comparator | Standard educational intervention Receives: Behavioral: Standard educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in knowledge about EbM/GSP
Difference in knowledge about EbM/GSP measured by alternating standardized, pre-validated, single-best/short-answer questionnaires consisting of 20 questions each
Measured: Before (day1), during (day 2) and after (day 4) intervention
Secondary outcomes (4)
Difference in skills about critically appraising scientific literature
Difference in skills about critically appraising scientific literature measured by alternating randomized-controlled trials evaluated by a standardized checklist related to items of the CONSORT statement.
Measured: Before (day 1), during (day 2) and after (day 4) intervention
Skills in teaching principles of EbM and GSP to high school students in intervention group
Skill in teaching principles of EbM and GSP are evaluated for preparation of lessons using a standardized preparation form and performance of lessons evaluated by transcription of video tapes from each participant in the intervention group using a consented evaluation catalogue
Measured: After educational intervention (day 5)
Overall acceptance of educational intervention study participants
Overall acceptance of educational intervention is evaluated by standardized questionnaires at day 2 and day 4 in the educational intervention group.
Measured: During (day 2) and after intervention (day 4)
Overall acceptance of study lessons for biology high-school students
Overall acceptance of study lessons for biology high-school students is evaluated by a standardized questionnaire at day 5.
Measured: After study lessons (day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startFeb 2010
- Primary completionSep 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reinhard Strametz, Goethe University
- Investigators
- Reinhard Strametz, MD, Principal investigator, EbM Working Group, Institute for General Practice, Faculty of Medicine, Goethe University, Frankfurt/Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567267
- Sponsor's protocol ID
- EbM@Bio-01
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2012
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Matic-Strametz M, Strametz R, Bohrt K, Ochsendorf F, Weberschock T. [Students in Training to Become Biology Teachers - a controlled phase II trial (NCT01567267)]. Z Evid Fortbild Qual Gesundhwes. 2013;107(1):53-61. doi: 10.1016/j.zefq.2012.11.017. Epub 2012 Dec 7. German.
PubMed 23415344
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of a Short Term Educational Intervention for Upcoming Biology Teachers to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes at High-school
- ClinicalTrials.gov ID
- NCT01567267
- Acronym / sponsor ID
- EbM@Bio-01
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- Evidence-based Medicine, Good Scientific Practice, Problem-based Learning, Critical health literacy, Educational intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 30 Mar 2012 (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.
The purpose of this study is to identify the effect of a short term educational intervention for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good Scientific Practice (GSP) to high-school biology students.
Detailed description
Shared decision making is increasingly demanded by patients in order to take part in health care decisions. However this demand for autonomy can only be used for shared decision making if the patient has basic skills in critical health literacy. To transfer health care literacy to young and healthy consumers educational intervention programs at high-school might be a feasible and effective way. This preliminary phase 2 study is designed to investigate the effect of an educational intervention to be integrated in a curriculum for upcoming teachers in biology.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental educational intervention | Experimental | Behavioral: Experimental educational interventionExperimental educational intervention |
| Standard educational intervention | Active comparator | Behavioral: Standard educational interventionStandard educational intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- students becoming biology teachers at participating university during enrollment period
Key exclusion criteria (1 listed)
- refusal to participate in study
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 |
|---|---|---|
| Experimental educational interventionEducational intervention consisting of a 4-day-course in Evidence-based Medicine and Good Scientific Practice combined with the method of Problem-based Learning. | Behavioural | Experimental educational intervention |
| Standard educational interventionEducational intervention on the didactics of biology (4-day-course) not containing elements of Evidence-based Medicine, Good Scientific Practice or Problem-based learning. | Behavioural | Standard educational intervention |
Primary outcome
Difference in knowledge about EbM/GSP
Time frame: Before (day1), during (day 2) and after (day 4) intervention
Difference in knowledge about EbM/GSP measured by alternating standardized, pre-validated, single-best/short-answer questionnaires consisting of 20 questions each
4 secondary outcomes
Difference in skills about critically appraising scientific literature
Time frame: Before (day 1), during (day 2) and after (day 4) intervention
Skills in teaching principles of EbM and GSP to high school students in intervention group
Time frame: After educational intervention (day 5)
Overall acceptance of educational intervention study participants
Time frame: During (day 2) and after intervention (day 4)
Overall acceptance of study lessons for biology high-school students
Time frame: After study lessons (day 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Derived from this study: PubMed 23415344Matic-Strametz M, Strametz R, Bohrt K, Ochsendorf F, Weberschock T. [Students in Training to Become Biology Teachers - a controlled phase II trial (NCT01567267)]. Z Evid Fortbild Qual Gesundhwes. 2013;107(1):53-61. doi: 10.1016/j.zefq.2012.11.017. Epub 2012 Dec 7. German.
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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.
Reinhard Strametz, MD principal investigator
EbM Working Group, Institute for General Practice, Faculty of Medicine, Goethe University, Frankfurt/Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental educational intervention and Standard educational intervention in people with Health Knowledge, Attitudes, Practice, run by Goethe University at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. 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 Germany. 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?
Results are not available in the source record.
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 in knowledge about EbM/GSP (time frame: Before (day1), during (day 2) and after (day 4) intervention). 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 NCT01567267, which also lists 1 linked publication.
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 3 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.