Your session is about to expire
← Back to Search
Communication Signage for Hearing Loss (SHIELD Trial)
N/A
Waitlist Available
Led By Nicholas S Reed, Au.D., Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once during hospitalization up to 6 months
Awards & highlights
SHIELD Trial Summary
This trial aims to study how sensory loss, such as hearing and vision loss, affects hospital patients with delirium. The researchers want to understand if sensory loss is related to an increased risk of del
Who is the study for?
This study is for English-speaking patients who can talk and are staying in certain units at Johns Hopkins Bayview. It's not for those who don't speak, can't communicate in English, or are under specific isolation precautions due to infection risks.Check my eligibility
What is being tested?
The study observes if hearing and vision loss relate to delirium risk and severity, affecting patient satisfaction. A trial part compares hospital units with different communication methods to see if this reduces delirium cases.See study design
What are the potential side effects?
Since the interventions involve using communication signage and amplifiers rather than medications, there aren't typical drug side effects. However, participants may experience discomfort or frustration if the devices don’t help as expected.
SHIELD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ once during hospitalization up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once during hospitalization up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium (4AT)
Number of Participants with Delirium as Assessed by 4AT Rapid Clinical Test for Delirium in Proportion to Total Number of Patients Screened
Secondary outcome measures
Satisfaction with Care Assessed Using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS)
Satisfaction with Care Assessed Using the Questionnaire on the Quality of Physician-Patient Interaction (QQPI)
Severity of Delirium Quantified by the 3-Minute Diagnostic Interview for Confusion Assessment Method-Defined Delirium (3D-CAM)
Other outcome measures
Binocular Contrast Sensitivity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
Binocular Distance Visual Acuity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
Binocular Near Visual Acuity Quantified with E-Book from National Health and Aging Trends Study (NHATS)
+1 moreSHIELD Trial Design
4Treatment groups
Active Control
Group I: Delirium & Sensory LossActive Control1 Intervention
The observational portion of the study, during which participants are screened for delirium. Consented individuals also complete bedside hearing and vision screenings, and provide information regarding care on patient satisfaction questionnaires.
Group II: Baseline Delirium PrevalenceActive Control1 Intervention
This arm of the interventional portion of the study will be used as baseline comparison data to determine whether implementation of the intervention impacted delirium outcomes. Baseline data collection will be collected for each of the units prior to implementation of the intervention.
Group III: Communication SignageActive Control1 Intervention
For patients who report a little or moderate trouble hearing following the implementation of the intervention, a pink sign will be posted to prompt use of effective communication strategies by nursing staff.
Group IV: AmplifierActive Control2 Interventions
For patients who report a lot of trouble hearing following the implementation of the intervention, a blue sign will be posted to prompt nursing staff to remind patient to make use of amplifier provided as part of the study.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,835,997 Total Patients Enrolled
12 Trials studying Hearing Loss
3,375 Patients Enrolled for Hearing Loss
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,019,385 Total Patients Enrolled
8 Trials studying Hearing Loss
1,302 Patients Enrolled for Hearing Loss
Nicholas S Reed, Au.D., Ph.D.Principal InvestigatorAssistant Professor, Department of Epidemiology
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there ongoing efforts to actively enroll participants for this research study?
"Indeed, the data available on clinicaltrials.gov confirms that this particular clinical trial is actively seeking eligible patients. The initial posting of the trial occurred on January 11th, 2023, and it was last edited on December 7th, 2023. Recruitment efforts aim to enroll a total of 1500 participants at a single research site"
Answered by AI
What is the current number of individuals being admitted into this research investigation?
"Indeed, the information available on clinicaltrials.gov indicates that this trial is currently seeking eligible participants. The trial was initially posted on January 11th, 2023 and underwent its most recent revision on December 7th, 2023. For successful completion of the study, a total of 1500 individuals are being sought from a single designated site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger