Age-related Macular DegenerationNCT04142164
Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections
A study testing MacInfo presentation in people with Age-related Macular Degeneration and Retinal Vein Occlusion, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Age-related Macular Degeneration, Retinal Vein Occlusion, Diabetic Macular Edema
- What is being tested?
- MacInfo presentation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 24 Oct 2019to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
Oliver Findl, MD, 01 91021-57564, office@viros.at
Manuel Ruiss, MSc., 01 91021-57564, office@viros.at
About this study
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
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.
Read the 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.
- Being tested
- MacInfo presentation, Placebo presentation
- Keywords
- Informed Consent Process
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacInfo presentationOther
Presentation about intravitreal drug injection
Placebo presentationOther
Placebo presentation
| Study group | Role | What they receive |
|---|---|---|
| MacInfo presentation | Active comparator | Patient will get access to an online version of the MacInfo presentation Receives: Other: MacInfo presentation |
| Placebo presentation | Placebo comparator | Patient will get access to an online version of a placebo presentation Receives: Other: Placebo presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start24 Oct 2019
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142164
- Sponsor's protocol ID
- MacInfo
- Status last verified
- Jan 2022
- First submitted
- 25 Oct 2019
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04142164
- Acronym / sponsor ID
- MacInfo
- Keywords
- Informed Consent Process
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MacInfo presentation | Active comparator | Other: MacInfo presentationPatient will get access to an online version of the MacInfo presentation |
| Placebo presentation | Placebo comparator | Other: Placebo presentationPatient will get access to an online version of a placebo presentation |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MacInfo presentationPresentation about intravitreal drug injection | Other | MacInfo presentation |
| Placebo presentationPlacebo presentation | Other | Placebo presentation |
Primary outcome
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 intravitreal drug injections. Correctly answered questions will be summated. The more points the better the patients' knowledge about intravitreal drug injections.
1 secondary outcome
Usability of the MacInfo tool
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Findl, MD principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MacInfo presentation in people with Age-related Macular Degeneration and Retinal Vein Occlusion, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Findl, MD (01 910201-57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of correctly answered questions between study group and control group (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.