NCT06362213

Brief Summary

The goal of this observational study is to explore difficulties in information access, mobility, communication and fatigue in people with combined vision and hearing impairments. The main question it aims to answer is: • What influence do varying severities of vision and hearing loss have on information access, mobility, communication and fatigue. Participants will fill out questionnaires and the researchers will measure their vision and hearing functions.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

April 8, 2024

Last Update Submit

April 8, 2024

Conditions

Keywords

information accessmobilitycommunicationfatiguevisual acuitycontrast sensitivityvisual fieldhearing thresholdspeech understanding in noisespeech understanding in silencedirectional hearing

Outcome Measures

Primary Outcomes (4)

  • information access

    Access to information will be measured with the Dutch ICF Activity Inventory (subscales 'Watching TV', 'Using a computer' and 'Using a telephone'). These subscales consist of 11, 13 and 5 items, respectively (29 items in total). All items are scored on a 5-point likert scale.

    1 day

  • mobility

    Mobility will be measured with the Dutch ICF Activity Inventory (subscales 'Mobility outdoors (walking)' and 'Using public transportation'). These subscales consist of 16 and 15 items, respectively (31 items in total). All items are scored on a 5-point likert scale. Secondly, the Spatial Localization Questionnaire20 will be used, consisting of 35 items, describing common scenarios. The following question structure is provided under each of the scenarios: Can you complete this task solely with your current vision? If yes, how difficult is it? (rated on a 5-point likert scale) Can you complete this task solely with your current hearing? If yes, how difficult is it? (rated on a 5-point likert scale) Would you primarily rely on your vision or hearing for this task? Do you use the other sense for this task at all?

    1 day

  • communication

    Communication will be measured with the Speech, Spatial and Qualities of Hearing Scale (speech subscale). This subscale consists of 14 items and is scored on an 11-point visual analog scale.

    1 day

  • fatigue

    Fatigue will be measured with the Dutch ICF Activity Inventory (feeling fit subscale). This subscale consists of 9 items, scored on a 5-point likert scale. Secondly, the Fatigue Assessment Scale will be used, consisting of 10 items, scored on a 5-point likert scale.

    1 day

Study Arms (4)

participants with dual sensory loss

participants with both vision and hearing loss

participants with vision loss

participants with vision loss only

participants with hearing loss

participants with hearing loss only

participants with normal vision and hearing

participants without vision or hearing loss

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with dual sensory loss have impairments in both vision and hearing, which can range from total vision and hearing loss to having limited residual vision and hearing.

You may qualify if:

  • Older than 18 years
  • Good understanding of the Dutch language
  • Clients: visual and/or auditory impairment (congenital or acquired)
  • Other participants: normal vision and hearing

You may not qualify if:

  • Impaired cognitive functioning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

CommunicationFatigue

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ruth MA van Nispen, prof.dr.

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Veenman, MSc

CONTACT

Ruth MA van Nispen, prof.dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.dr. R.M.A. van Nispen

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 12, 2024

Study Start

April 15, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

April 12, 2024

Record last verified: 2024-04

Locations