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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05966623
Other study ID # -2021-05-50-M1
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 24, 2023
Est. completion date July 14, 2024

Study information

Verified date November 2023
Source University of Geneva, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 a formal or informal interpreter, for Deaf patients aged 18 and older in Bogota Colombia


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 183
Est. completion date July 14, 2024
Est. primary completion date July 14, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Video Remote Interpretation
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.

Locations

Country Name City State
Colombia Clinica Nuestra Senora de la Paz Bogota
Colombia Hospital Universitario Mayor Mederi Bogotá

Sponsors (4)

Lead Sponsor Collaborator
University of Geneva, Switzerland Clinica Nuestra Senora de la Paz, Hospital Universitario Mayor Mederi, Universidad del Rosario

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
12 months
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