Computer-based Tutorial for the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients
NCT ID: NCT03748368
Last Updated: 2019-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2017-01-01
2020-07-01
Brief Summary
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Detailed Description
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A novel concept introduced several years ago is to use a multimedia tool including a so-called traffic light system. The patient sees and hears information concerning cataract surgery on a touch screen and after each short chapter a traffic light is shown on the touch screen. At this point the patient has to decide, whether everything is clear and he wants to continue (green light), if he has further questions for the ophthalmologist (yellow light), or if he wants to repeat the chapter (red light). The patient's feedback for each chapter is then printed and guides the ophthalmologist during the face to face interview. This approach is called "CatInfo tool".
The German version of the CatInfo tool has been developed and evaluated in a previous study. In short, the CatInfo tool was developed as a multidisciplinary project including patients, graphic designers and ophthalmologists. The first version of the tool was evaluated in patient focus-groups. Afterwards, an evaluation study including 60 patients was performed. Main outcome was the following: patients who used the CatInfo tool were significantly better informed than patients only having a face to face interview with an ophthalmologist and the feedback concerning the CatInfo tool was good. Meanwhile the German version of the CatInfo tool is part of our daily routine and thousands of patients profited from the CatInfo tool consent always additional to the face to face interview with an ophthalmologist. However, some patients are not able to use the CatInfo tool. One reason is that they are not literate in German. Aim of this study is to translate and evaluate a Serbian and Turkish version of the CatInfo tool to allow better access.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Cataract presentation
Cataract presentation prior to surgery
Cataract presentation
Presentation about cataract surgery
Placebo presentation
Placebo presentation prior to surgery
Placebo presentation
Presentation about the history of the hospital
Interventions
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Cataract presentation
Presentation about cataract surgery
Placebo presentation
Presentation about the history of the hospital
Eligibility Criteria
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Inclusion Criteria
* Age 21 and older
* First eye to be operated
* No previous ophthalmic surgery
* Written informed consent to participation in the study
Exclusion Criteria
* Visual acuity of less than 6/60 in the worse eye
* Severe hearing loss
* Inability to use touch screen device (e.g. severe tremor, etc.)
* Pregnancy - for women in the reproductive age a pregnancy test is required
21 Years
105 Years
ALL
No
Sponsors
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Prim. Prof. Dr. Oliver Findl, MBA
OTHER
Responsible Party
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Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Locations
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Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CatInfo SK/TK
Identifier Type: -
Identifier Source: org_study_id
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