- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01567267
Evaluation of Educational Intervention to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes
March 1, 2017 updated by: Reinhard Strametz, Goethe University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Siegen, Germany, 57068
- University of Siegen, Section of biology and und their didactics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- students becoming biology teachers at participating university during enrollment period
Exclusion Criteria:
- refusal to participate in study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental educational intervention
|
Educational intervention consisting of a 4-day-course in Evidence-based Medicine and Good Scientific Practice combined with the method of Problem-based Learning.
|
Active Comparator: Standard educational intervention
|
Educational intervention on the didactics of biology (4-day-course) not containing elements of Evidence-based Medicine, Good Scientific Practice or Problem-based learning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Before (day1), during (day 2) and after (day 4) intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in skills about critically appraising scientific literature
Time Frame: Before (day 1), during (day 2) and after (day 4) intervention
|
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.
|
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)
|
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
|
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 educational intervention is evaluated by standardized questionnaires at day 2 and day 4 in the educational intervention group.
|
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)
|
Overall acceptance of study lessons for biology high-school students is evaluated by a standardized questionnaire at day 5.
|
After study lessons (day 5)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Reinhard Strametz, MD, EbM Working Group, Institute for General Practice, Faculty of Medicine, Goethe University, Frankfurt/Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
May 1, 2019
Study Registration Dates
First Submitted
March 14, 2012
First Submitted That Met QC Criteria
March 29, 2012
First Posted (Estimate)
March 30, 2012
Study Record Updates
Last Update Posted (Actual)
March 3, 2017
Last Update Submitted That Met QC Criteria
March 1, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EbM@Bio-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Health Knowledge, Attitudes, Practice
-
Amref Health AfricaRecruitingHealth Knowledge, Attitudes, PracticeKenya
-
Nigde Omer Halisdemir UniversityGazi University; Ankara Yildirim Beyazıt UniversityRecruitingHealth Knowledge, Attitudes, PracticeTurkey
-
Bournemouth UniversityUniversity College, London; University of Leeds; University of SouthamptonCompletedHealth Knowledge, Attitudes, PracticeUnited Kingdom
-
Galderma R&DCompletedHealth Knowledge, Attitudes, PracticeFrance, Germany, Spain, United Kingdom
-
Virginia Commonwealth UniversityCompletedHealth Knowledge, Attitudes, PracticeUnited States
-
Chang Gung Memorial HospitalCompletedHealth Knowledge, Attitudes, PracticeTaiwan
-
Continuity Research NetworkCompletedHealth Knowledge, Attitudes, PracticeUnited States
-
Harvard School of Public Health (HSPH)RecruitingHealth Knowledge, Attitudes, PracticeUnited States
-
Ankara Yildirim Beyazıt UniversityNot yet recruitingHealth Knowledge, Attitudes, PracticeTurkey
-
Harvard School of Public Health (HSPH)CompletedHealth Knowledge, Attitudes, PracticeUnited States
Clinical Trials on Experimental educational intervention
-
Clinica Universidad de Navarra, Universidad de...Completed
-
Assistance Publique - Hôpitaux de ParisCompletedDiabetes Mellitus | Type 1 DiabetesFrance
-
The Hong Kong Polytechnic UniversityUnknownOlder Adults With Mild to Moderate Level of DementiaHong Kong
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedBacterial Infection | Clostridium DifficileUnited States
-
McGill University Health Centre/Research Institute...University of Manitoba; Sunnybrook Health Sciences Centre; University of Alberta and other collaboratorsCompletedPeptic Ulcer Hemorrhage
-
Universidad de GranadaNot yet recruitingAsthma | Allergy
-
Roswell Park Cancer InstituteCompletedCervical Cancer | Breast CancerUnited States
-
US Department of Veterans AffairsDuke UniversityCompletedAccidental FallsUnited States
-
Gary MorrowNational Cancer Institute (NCI)CompletedMalignant NeoplasmUnited States
-
Kastamonu UniversityCompleted