Computer-based Tutorial for the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cataract presentation
Placebo presentation
Sponsored by
About this trial
This is an interventional other trial for Cataract focused on measuring Cataract surgery, Informed Consent Process
Eligibility Criteria
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
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cataract presentation
Placebo presentation
Arm Description
Cataract presentation prior to surgery
Placebo presentation prior to surgery
Outcomes
Primary Outcome Measures
Number of correctly answered questions between study group and control group
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
Secondary Outcome Measures
Usability of the touchscreen device
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
Full Information
NCT ID
NCT03748368
First Posted
November 19, 2018
Last Updated
October 1, 2019
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT03748368
Brief Title
Computer-based Tutorial for the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Investigate if a computer-based tutorial enhances the quality and efficiency of the informed consent process for cataract surgery in Turkish or Serbian speaking patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract surgery, Informed Consent Process
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cataract presentation
Arm Type
Active Comparator
Arm Description
Cataract presentation prior to surgery
Arm Title
Placebo presentation
Arm Type
Placebo Comparator
Arm Description
Placebo presentation prior to surgery
Intervention Type
Other
Intervention Name(s)
Cataract presentation
Intervention Description
Presentation about cataract surgery
Intervention Type
Other
Intervention Name(s)
Placebo presentation
Intervention Description
Presentation about the history of the hospital
Primary Outcome Measure Information:
Title
Number of correctly answered questions between study group and control group
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Usability of the touchscreen device
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Hirnschall, MD
Phone
01 91021-57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Ruiß, MSc.
Phone
01 91021-57564
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1149
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nino Hirnschall, MD
Phone
01 91021-57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Manuel Ruiß, MSc.
Phone
01 91021-57564
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Computer-based Tutorial for the Informed Consent Process for Cataract Surgery in Turkish or Serbian Speaking Patients
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