Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections
Primary Purpose
Age-related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
MacInfo presentation
Placebo presentation
Sponsored by
About this trial
This is an interventional other trial for Age-related Macular Degeneration focused on measuring Informed Consent Process
Eligibility Criteria
Inclusion Criteria:
- Age 21 or older
- Patients with a need for intravitreal drug administration: wet, age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal venous occlusion
- No previous intravitreal injections
- Willingness and written informed consent to participate in the study
Exclusion Criteria:
- Not literate in German
- Visual acuity of less than 6/60 in the worse eye
- Severe hearing loss
- Inability to use a 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), Hanusch Hospital ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MacInfo presentation
Placebo presentation
Arm Description
Patient will get access to an online version of the MacInfo presentation
Patient will get access to an online version of a placebo presentation
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 intravitreal drug injections. Correctly answered questions will be summated. The more points the better the patients' knowledge about intravitreal drug injections.
Secondary Outcome Measures
Usability of the MacInfo tool
By using an visual analogue scale ranging from 0 (worst usability) to 10 (best usability) patients will be asked about their impression concerning usability of the MacInfo tool
Full Information
NCT ID
NCT04142164
First Posted
October 25, 2019
Last Updated
January 24, 2022
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT04142164
Brief Title
Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections
Official Title
Computer-based Tutorial and Automated Speech Recognition as Supportive Means to Enhance the Patient Experience and Improve the Efficiency of the Informed Consent Process for Intravitreal Drug Injections
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation if a computer-based tutorial ("MacInfo" tool) improves the patients' knowledge about intravitreal drug injections, associated risks, and the underlying diseases of treatment-naive patients.
Detailed Description
Informing the patient an 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 the utilization of a multimedia tool including a so-called traffic light system. At our clinic, a computer-based tutorial for informed consent of patients undergoing cataract surgery ("CatInfo" tool) was developed and tested. The patients see and hear a presentation covering the topics of cataract disease, the surgery, and associated risks and complications. After each chapter a graphic representation of a traffic light is shown on the screen. At this page the patient has three choices: if the patient understood everything and wish to continue, the green bar has to be clicked; if there are further questions, the patient clicks the yellow bar; or if the patient wishes to repeat the chapter due to any reason, the patient clicks the red bar.
In previous studies, it was shown that patients who used the CatInfo tool had better knowledge about cataract surgery compared to the ones that saw a placebo video. Furthermore, the overall satisfaction of patients with the CatInfo tool was high (median 9.1 of 10 measured with a visual analogue scale).
Since many cataract patients benefited from using the CatInfo tool, the idea arose to create and test a similar multimedia information tool for patients receiving a drug injection into the vitreous of the eye for treatment of retinal diseases (e.g. patients suffering from neovascular age-related macular degeneration, diabetic macular edema, or retinal venous occlusive disease). Therefore, the "MacInfo" tool was developed as a multidisciplinary project including patients, graphic designers, and ophthalmologists.
Furthermore, it would be helpful for the physician to have a legal valid and written documentation of the informed consent process, serving as proof that the patient was informed correctly about all necessary topics concerning the medical treatment, expected benefits, risks, complications, etc. A novel and technology-driven approach may be the use of Automated Speech Recognition (ASR). ASR records the informed consent discussion, followed by an algorithmic analysis of the conversation, and a subsequent translation of the interaction into a legally valid document.
The aim of this study is to evaluate if the "MacInfo" tool improves the patients' knowledge about intravitreal drug injections, associated risks and the underlying diseases of treatment-naive patients and if ASR is a suitable technology for improving informed consent process documentation in daily routine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema
Keywords
Informed Consent Process
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MacInfo presentation
Arm Type
Active Comparator
Arm Description
Patient will get access to an online version of the MacInfo presentation
Arm Title
Placebo presentation
Arm Type
Placebo Comparator
Arm Description
Patient will get access to an online version of a placebo presentation
Intervention Type
Other
Intervention Name(s)
MacInfo presentation
Intervention Description
Presentation about intravitreal drug injection
Intervention Type
Other
Intervention Name(s)
Placebo presentation
Intervention Description
Placebo presentation
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 intravitreal drug injections. Correctly answered questions will be summated. The more points the better the patients' knowledge about intravitreal drug injections.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Usability of the MacInfo tool
Description
By using an visual analogue scale ranging from 0 (worst usability) to 10 (best usability) patients will be asked about their impression concerning usability of the MacInfo 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:
Age 21 or older
Patients with a need for intravitreal drug administration: wet, age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal venous occlusion
No previous intravitreal injections
Willingness and written informed consent to participate in the study
Exclusion Criteria:
Not literate in German
Visual acuity of less than 6/60 in the worse eye
Severe hearing loss
Inability to use a 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
Oliver Findl, MD
Phone
01 910201-57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Ruiss, MSc.
Phone
01 910201-57564
Email
office@viros.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, 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
No
Learn more about this trial
Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections
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