Dual Sensory Impairment Low Vision Rehabilitation (LVR) Initiative

NCT03664349 | Completed

• 2 other identifiers: IRB00183648LVR-F-1
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dual Sensory Impairment of Vision and Hearing

Outcome Measures

Primary Outcomes (1)

• Prevalence of Dual Sensory Impairment

  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.

  1 day

Secondary Outcomes (3)

• Impact of Dual Sensory Impairment on Formal/informal Caregivers by 12 Question Zarit Burden Interview Questionnaire (Range 0-48, 0-10 mild burden, 10-20 mild to moderate burden, >20 high burden)

  1 day

• Feasibility of Handheld Amplifier on Communication with Formal/Informal Caregivers as assessed by Semi Structured Interviews

  4-6 Weeks

• Impact of Handheld Amplifier on Caregiver Burden with Formal/Informal Caregivers as assessed by Zarit Burden Interview Questionnaire

  4-6 Weeks

Study Arms (3)

Older Adult Participants and Informal/Formal Caregiver Pairs

A sub-cohort of approximately 10 participant-caregiver pairs will utilize SE9000 and communication strategies over a 4-6-week period between LVR visits.

Device: SuperEar9000

Older Adult Participants

The pilot cohort of approximately 100 adults over age 60, with vision impairment, will complete the Hearing Handicap Inventory for the Elderly (HHIE), an assessment of perceived impact of hearing impairment, and an objective hearing evaluation.

Formal/Informal Caregivers

Identified persons who assist willing and eligible older adult pilot participants with two or more ADLs/IADLs.

Interventions

SuperEar9000 DEVICE

Handheld hearing amplifier, not FDA regulated.

Older Adult Participants and Informal/Formal Caregiver Pairs

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Aim 1 and Aim 2: 100 participants (convenience sample) and their identified people who assist with two or more ADLs/IADLs recruited from Wilmer Eye Institute's LVR clinic Aim 3: sub-cohort of 10 participants with dual sensory impairment and their identified people who assist with two or more ADLs/IADLs

You may qualify if:

• To be eligible for aims 1 \& 2 of the study, older adult participants must meet all of the following criteria:
• Age over 60 years. Individuals aged over 60 years at the time of recruitment are eligible for participation.
• Low Vision Rehab Patient/Attendee
• Fluent English Speaker
• Caregiver who reports aiding in 2 or More ADLs/IADLs.
• Residency. Participants must plan to reside in the local area for the pilot duration
• Willingness to participate and adhere to the protocol. Participants must be willing and able to consent to participate in the study, be willing to adhere to the pilot protocol for the duration of the pilot (1 session for aim 1 and aim 2, 2 sessions 4-6 weeks apart for aim 3).
• To be eligible for aim 3 of the study, older adult participants must meet the following additional criteria:
• Dual Sensory Impairment (only for aims 2 and 3)
• Hearing Impairment. Participant hearing will be measured by pure tone audiometry a four-frequency test in both ears. Hearing impairment score \>=25dB in better ear.
• Caregiver (Identified People who Assist with Two or More ADLs/IADLs) Participants
• To be eligible for aims 2 \& 3 of the study, caregiver participants must meet the following criteria:
• Assist an eligible and willing older adult pilot participant with two or more ADLs/IADLs.

You may not qualify if:

• Potential candidates for enrollment who meet one or more of the following criteria are excluded from participation in the study:
• Medical contraindication to use handheld amplifier. Because hearing amplifier will be the primary device used in the hearing intervention, participants with medical contraindications to hearing amplifier use are excluded. Contraindication will be determined by pilot audiologist. These may include:
• Active ear infection
• Atresia
• Profound hearing loss beyond the limits of the device
• Asymmetrical hearing loss
• Central hearing loss (i.e. neurologic in origin)
• Free from Vision Impairment. Participants will be excluded who have no vision impairment after refraction on acuity, visual field status and contrast sensitivity as assessed by a low vision rehabilitation clinician.
• Depression. Screened with Center for Epidemiological Studies-Depression (CES-D) score ≥16.
• No participants are excluded based on race or sex.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Low Vision Rehabilitation Clinic, Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Study Officials

• Nick Reed, AuD

  Johns Hopkins Bloomberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: November 26, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 20, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)