- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05966623
Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare (Impact of VRI)
Assessing the Impact of Vidéo Remote Sign Language Interpreting in Healthcare: Linking Disability Studies With Empirical Challenges of Public Health Research
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bogota, Colombia, 110831
- Clínica Nuestra Señora de la Paz
-
Bogotá, Colombia, 111411
- Hospital Universitario Mayor Méderi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Uses Colombian Sign Language as the preferred language.
- Enough sensorimotor, cognitive and communication skills to communicate independently with health personnel
Exclusion Criteria:
- 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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental VRI sign language interpretation
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
|
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.
|
|
No Intervention: Experimental: primo control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- -2021-05-50-M1
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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