NCT05966623

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

August 24, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

July 17, 2023

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

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.

Experimental VRI sign language interpretation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uses Colombian Sign Language as the preferred language.
  • Enough sensorimotor, cognitive and communication skills to communicate independently with health personnel

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinica Nuestra Senora de la Paz

Bogotá, 110831, Colombia

Location

Hospital Universitario Mayor Mederi

Bogotá, 111411, Colombia

Location

Related Publications (2)

  • 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.

  • Rivas 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.

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Single-blinded - The researcher needs to learn before the patient comes to the hospital as VRI needs to be organised. Thus, they will only know if the participants shall be assigned to the intervention or control group after the patient agrees to take part. Double blinding is not feasible as interpreters will not be available 24x7.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group Leader

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 28, 2023

Study Start

August 24, 2023

Primary Completion

July 14, 2024

Study Completion

July 14, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations