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NCT03664349 · ClinicalTrials.gov registry record
Dual Sensory Impairment Low Vision Rehabilitation (LVR) Initiative
A clinical trial of Dual Sensory Impairment of Vision and Hearing, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 168
- Enrollment target
- 1
- Study location
NCT03664349: Completed study of Dual Sensory Impairment of Vision and Hearing, sponsored by Johns Hopkins University.
NCT03664349 is a study of Dual Sensory Impairment of Vision and Hearing that has completed, run by Johns Hopkins University. The registered enrollment target is 168 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03664349, a study of Dual Sensory Impairment of Vision and Hearing, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 168 participants
- Enrollment target
- 1
- Study location
Study Summary
The aims of the Improving Communication with Formal/Informal Caregivers among Older Adults with Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic (LVR) are: Primary aims Aim 1 To characterize prevalence of objective hearing impairment (i.e. DSI) among a clinical LVR population) in older adults (≥60 years) with English proficiency free from moderate to severe depression or cognitive decline using the Hearing Handicap Inventory for the Elderly (HHIE) assessment and an objective hearing evaluation. Aim 2 To describe the perceived burden of care on primary caregiver (identified people who assist with two or more activities of daily living. instrumental activities of daily living (ADLs/Instrumental activities of daily living (IADLs))of individuals with dual sensory impairment (DSI) among a clinical LVR population in older adults (≥60 years) with English proficiency free from moderate to severe depression or cognitive decline using the Zarit Burden Interview questionnaire and qualitative interview data analyses. Aim 3 To determine feasibility and benefit of a pilot manualized over-the-counter hearing intervention program on LVR patients to address communication among a DSI population using the Zarit Burden Interview questionnaire. 3A: Describe feasibility based on completion of pilot, drop-out rate, and semi-structured interviews 3B: Describe perceived communication improvements based on semi-structured interviews
Primary Outcome
Measured by the Hearing Handicap Inventory for the Elderly (HHIE), an assessment of perceived impact of hearing impairment, and an objective hearing evaluation (by pure tone audiometry a four-frequency test in both ears. Hearing impairment score \>25dB in better ear). Total HHIE score: summation of 10 items (0, 2 or 4 points per item, total score range 0 to 40). 0-8 = no handicap; 10-24 = mild to moderate handicap; 26-40 = severe handicap.
Conditions Studied
Interventions
- DEVICE SuperEar9000
Study Locations (1)
Maryland
- Low Vision Rehabilitation Clinic, Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2019-09-20 |
What the finished NCT03664349 record still lists
NCT03664349 is an observational study that tracks outcomes without assigning an intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Dual Sensory Impairment of Vision and Hearing appearing as the primary indexed condition, and to 1 intervention - of which SuperEar9000 is the first listed.
NCT03664349 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03664349 about?
NCT03664349 is a clinical study titled "Dual Sensory Impairment Low Vision Rehabilitation (LVR) Initiative". The aims of the Improving Communication with Formal/Informal Caregivers among Older Adults with Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic (LVR) are: Primary aims Aim 1 To characterize prevalence of objective hearing impairment (i.e. DSI) amon...
What is the current status of trial NCT03664349?
This trial is currently completed. The enrollment target is 168 participants. The study started on 2018-11-26. Estimated completion is 2019-09-20.
What conditions does trial NCT03664349 study?
This clinical trial studies the following conditions: Dual Sensory Impairment of Vision and Hearing.
What interventions are being tested in trial NCT03664349?
The interventions under investigation include: SuperEar9000 (DEVICE).
Who is sponsoring clinical trial NCT03664349?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03664349 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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