- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03748368
Computer-based Tutorial for the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients
Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Informing the patient and obtaining informed consent is one of the major duties physicians have to perform before beginning a medical treatment. However, patients often experience the informed consent taking as not satisfying. In the past, several approaches were used to try to improve the informed consent taking, such as printed information sheets and multimedia tools.
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manuel Ruiss, MSc.
- Phone Number: 01 91021-57564
- Email: office@viros.at
Study Contact Backup
- Name: Nino Hirnschall, MD
- Phone Number: 01 91021-57564
- Email: office@viros.at
Study Locations
-
-
-
Vienna, Austria, 1149
- Recruiting
- Vienna Institute for Research in Ocular Surgery (VIROS)
-
Contact:
- Manuel Ruiss, MSc.
- Phone Number: 01 91021-57564
- Email: office@viros.at
-
Contact:
- Nino Hirnschall, MD
- Phone Number: 01 91021-57564
- Email: office@viros.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cataract
- Age 21 and older
- First eye to be operated
- No previous ophthalmic surgery
- Written informed consent to participation in the study
Exclusion Criteria:
- Not literate in Serbian (Serbian group) / Turkish (Turkish group) or German (both groups)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cataract presentation
Cataract presentation prior to surgery
|
Presentation about cataract surgery
|
Placebo Comparator: Placebo presentation
Placebo presentation prior to surgery
|
Presentation about the history of the hospital
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of correctly answered questions between study group and control group
Time Frame: 12 months
|
Patients are asked to complete a multiple choice questionnaire concerning cataract surgery.
Correctly answered questions will be summated.
The scale ranges from a minimum of 0 points to a maximum of 19 points.
The more points the better the patients knowledge about cataract
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability of the touchscreen device
Time Frame: 12 months
|
By using an audiovisual analogue scale ranging from 0 (worst usability) to 10 (best usability) patients will be asked about their impression concerning usability of the CatInfo tool
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CatInfo SK/TK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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