DeafnessImpact of VRINCT05966623
Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare
A study testing Video Remote Interpretation in people with Deafness, run by University of Geneva, Switzerland at 2 sites in Colombia.
Trial summary
This is a randomise study that looks at what is the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors versus the 'available standard of care of the usual communication tools, including informal interpretation, lip or note reading, using their mobile phones to contact… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Video Remote Interpretation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 2 sitesColombia
- Study dates
- 24 Aug 2023to 14 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Uses Colombian Sign Language as the preferred language.
- Enough sensorimotor, cognitive and communication skills to communicate independently with health personnel
Who cannot join
- Does not communicate using sign language.
- Additional impairments which affect language development or the use of sign language.
- Refusal of the participant's representative(s) to participate in the study,
- Refusal of the participant's representative(s) to participate in a modality of the study,
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Clinica Nuestra Senora de la Paz
Bogotá, 110831
Hospital Universitario Mayor Mederi
Bogotá, 111411
About this study
Official title: Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare: Linking Disability Studies With Empirical Challenges of Public Health Research
This is a randomise study that looks at what is the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors versus the 'available standard of care of the usual communication tools, including informal interpretation, lip or note reading, using their mobile phones to contact a formal or informal interpreter, for Deaf patients aged 18 and older in Bogota Colombia
Read the detailed description
Background and Rationale:
In-person or VRI sign language interpretation is largely unavailable. In a scoping review, the researchers identified a knowledge gap regarding the quality of interpretation and training in sign language interpretation for health care. The researchers also found that this area is under-researched, and the evidence is scant. All available evidence came from high-income countries, which is particularly problematic given that most DHH persons live in low- and middle-income countries. Thus, the available literature shows that VRI may enable deaf users to overcome interpretation barriers and can potentially improve communication outcomes between them and health personnel within health care services. For VRI to be acceptable, sign language users require a VRI system supported by devices with large screens and a reliable internet connection, as well as qualified interpreters trained in medical interpretation. There is no clear data on the availability of VRI or in-person interpretation. Given the cost, VRI may be more available than in person. Available data tend to focus on assessing personal references of Deaf users in regards to interpretation, as well as interpreters' preferences and maximising recourses allocation.
Objective(S):
To assess the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people that will be tested, implemented, and sustained in Bogota, Colombia.
Explanation for choice of comparator
In-person or VRI sign language interpretation is largely unavailable. Thus, there is no clear data on the magnitude of the availability gap of VRI or in-person interpretation. In-person qualified sign language interpretation in the healthcare setting tends to be described as the ideal standard of service provision. Thus, it is largely unavailable even in HIC. The assumption is based upon minimal available evidence on the personal preferences of Deaf persons in the USA. There is no evidence that in-person interpretation is efficient in the context of weaker infrastructure, such as low sign language literacy rates across Deaf persons, lack of standard qualification of interpreters and lack of interpreters and sustainable financing in HIC. To my knowledge, there is no study assessing DPC while using sign language interpretation.
Given the cost, VRI may be more sustainable than in-person. Assessing the efficiency of VRI versus the standard of care would be d of more value, given that there is no other effective intervention to compare.
- Conditions
- Deafness
- Being tested
- Video Remote Interpretation
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Remote InterpretationOther
To assess the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people that will be tested, implemented, and sustained in Bogota Colombia.
| Study group | Role | What they receive |
|---|---|---|
| Experimental VRI sign language interpretation | Experimental | Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication Receives: Other: Video Remote Interpretation |
| Experimental: primo control | No intervention | Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication outcomes
The score of a selected' scale assesses A: creating a good interpersonal relationship, B: exchanging information, and C: Making treatment-related decisions that involve the patients in decision-making.
The results of the scale will be asses using descriptive analytics (Fisher exact test will be applied to compare the 2 groups) Multiple regression analysis will be applied using demographic data and health indicators.
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 posted28 Jul 2023
- Study start24 Aug 2023
- Primary completion14 Jul 2024 (estimated)
- Study completion14 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm Intervention Experimental VRI sign language interpretation Participants will be welcome from their entry point to the hospital, they will attend a general check-up with a GP or other services and be provided with VRI until they leave Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication Experimental: primo control Participants get welcome at the entry point of the hospital, they will attend a general check-up with a GP or other services and they are not provided with by the study with VRI Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication
- Masking
- None (open label)
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad del Rosario, Hospital Universitario Mayor Mederi, Clinica Nuestra Senora de la Paz
- Responsible party
- Principal investigator, Minerva Rivas Velarde, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966623
- Sponsor's protocol ID
- -2021-05-50-M1
- Acronym
- Impact of VRI
- Status last verified
- Nov 2023
- First submitted
- 17 Jul 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rivas Velarde M, Izquierdo Martinez LC, Dalal J, Martinez-R A, Guevara Rojas KL, Parra Valero NA, Cruz Reyes DL, Cuculick J, Vallejo-Silva A, Irreno-Sotomonte J, Groce N. Video Remote Sign Language Interpreting and Health Communication for Deaf Patients: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2557189. doi: 10.1001/jamanetworkopen.2025.57189.
PubMed 41637069Rivas Velarde M, Izquierdo Martinez LC, Dalal J, Martinez-R A, Cruz Reyes DL, Cuculick J, Vallejo-Silva A, Irreno-Sotomonte J, Groce N. Video Remote Sign Language Interpreting in Health Communication for Deaf People: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 2;13:e64590. doi: 10.2196/64590.
PubMed 39622021
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare: Linking Disability Studies With Empirical Challenges of Public Health Research
- ClinicalTrials.gov ID
- NCT05966623
- Acronym / sponsor ID
- Impact of VRI / -2021-05-50-M1
- Conditions
- Deafness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- Universidad del Rosario, Hospital Universitario Mayor Mederi, Clinica Nuestra Senora de la Paz
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 14 Jul 2024 (estimated)
- Study completion
- 14 Jul 2024 (estimated)
- First posted
- 28 Jul 2023 (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.
This is a randomise study that looks at what is the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors versus the 'available standard of care of the usual communication tools, including informal interpretation, lip or note reading, using their mobile phones to contact a formal or informal interpreter, for Deaf patients aged 18 and older in Bogota Colombia
Detailed description
Background and Rationale:
In-person or VRI sign language interpretation is largely unavailable. In a scoping review, the researchers identified a knowledge gap regarding the quality of interpretation and training in sign language interpretation for health care. The researchers also found that this area is under-researched, and the evidence is scant. All available evidence came from high-income countries, which is particularly problematic given that most DHH persons live in low- and middle-income countries. Thus, the available literature shows that VRI may enable deaf users to overcome interpretation barriers and can potentially improve communication outcomes between them and health personnel within health care services. For VRI to be acceptable, sign language users require a VRI system supported by devices with large screens and a reliable internet connection, as well as qualified interpreters trained in medical interpretation. There is no clear data on the availability of VRI or in-person interpretation. Given the cost, VRI may be more available than in person. Available data tend to focus on assessing personal references of Deaf users in regards to interpretation, as well as interpreters' preferences and maximising recourses allocation.
Objective(S):
To assess the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people that will be tested, implemented, and sustained in Bogota, Colombia.
Explanation for choice of comparator
In-person or VRI sign language interpretation is largely unavailable. Thus, there is no clear data on the magnitude of the availability gap of VRI or in-person interpretation. In-person qualified sign language interpretation in the healthcare setting tends to be described as the ideal standard of service provision. Thus, it is largely unavailable even in HIC. The assumption is based upon minimal available evidence on the personal preferences of Deaf persons in the USA. There is no evidence that in-person interpretation is efficient in the context of weaker infrastructure, such as low sign language literacy rates across Deaf persons, lack of standard qualification of interpreters and lack of interpreters and sustainable financing in HIC. To my knowledge, there is no study assessing DPC while using sign language interpretation.
Given the cost, VRI may be more sustainable than in-person. Assessing the efficiency of VRI versus the standard of care would be d of more value, given that there is no other effective intervention to compare.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm Intervention Experimental VRI sign language interpretation Participants will be welcome from their entry point to the hospital, they will attend a general check-up with a GP or other services and be provided with VRI until they leave Participants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication Experimental: primo control Participants get welcome at the entry point of the hospital, they will attend a general check-up with a GP or other services and they are not provided with by the study with VRI Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication
| Arm | Type | Receives |
|---|---|---|
| Experimental VRI sign language interpretation | Experimental | Other: Video Remote InterpretationParticipants will be provided with a Tablet of 14' inches with interrupted VRI in Colombian Sign Language. Professionally accredited Sign language interpreter. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-Communication |
| Experimental: primo control | No intervention | –Participants get welcome at the entry point of the hospital, they are not provided with VRI. At the end of the hospital visit, they will complete a scale measuring Doctor-Patient-communication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Uses Colombian Sign Language as the preferred language.
- Enough sensorimotor, cognitive and communication skills to communicate independently with health personnel
Key exclusion criteria (4 listed)
- Does not communicate using sign language.
- Additional impairments which affect language development or the use of sign language.
- Refusal of the participant's representative(s) to participate in the study,
- Refusal of the participant's representative(s) to participate in a modality of the study,
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 |
|---|---|---|
| Video Remote InterpretationTo assess the effectiveness of the VRI system in improving communication outcomes between Deaf patients and doctors Produce a VRI model addressing the challenges faced by Deaf people that will be tested, implemented, and sustained in Bogota Colombia. | Other | Experimental VRI sign language interpretation |
Primary outcome
Communication outcomes
Time frame: 12 months
The score of a selected' scale assesses A: creating a good interpersonal relationship, B: exchanging information, and C: Making treatment-related decisions that involve the patients in decision-making. The results of the scale will be asses using descriptive analytics (Fisher exact test will be applied to compare the 2 groups) Multiple regression analysis will be applied using demographic data and health indicators.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 41637069Rivas Velarde M, Izquierdo Martinez LC, Dalal J, Martinez-R A, Guevara Rojas KL, Parra Valero NA, Cruz Reyes DL, Cuculick J, Vallejo-Silva A, Irreno-Sotomonte J, Groce N. Video Remote Sign Language Interpreting and Health Communication for Deaf Patients: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2557189. doi: 10.1001/jamanetworkopen.2025.57189.
- Derived from this study: PubMed 39622021Rivas Velarde M, Izquierdo Martinez LC, Dalal J, Martinez-R A, Cruz Reyes DL, Cuculick J, Vallejo-Silva A, Irreno-Sotomonte J, Groce N. Video Remote Sign Language Interpreting in Health Communication for Deaf People: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 2;13:e64590. doi: 10.2196/64590.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Remote Interpretation in people with Deafness, run by University of Geneva, Switzerland at 2 sites in Colombia.
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 2 inclusion and 4 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication outcomes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966623, which also lists 2 linked publications.
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 29 Nov 2023.