Dual Sensory Impairment Low Vision Rehabilitation (LVR) Initiative

NCT ID: NCT03664349

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 168 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2019-09-20

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

Detailed Description

The pilot is a prospective cohort study. Approximately 100 participants and their identified people who assist with two or more ADLs/IADLs will be assessed for DSI prevalence and DSI impact on communication. A sub-cohort of 10 participants with DSI will be provided a hearing intervention and followed for 4-6 weeks to assess the over-the-counter hearing intervention program's impact on communication among a DSI population and its identified people who assist with two or more ADLs/IADLs.

Recruitment will be based at the Wilmer Eye Institute (East Baltimore location) LVR clinic. Recruitment efforts will focus on older adults (≥60 years) with English proficiency attending the LVR clinic. Caregivers will be identified based on self-report assistance with at least two ADLs and/or IADLs.

The hearing intervention, for the sub-cohort of 10 individuals with DSI and their identified people who assist with two or more ADLs/IADLs, consists of instruction and best-practices provided by an occupational therapist on the utilization of a handheld amplifier (SuperEar SE9000). Prior to the LVR session with the handheld amplifier, individuals with DSI will complete a daily functioning (ADLs/IADLs) questionnaire (a measure of LVR success). The occupational therapist will give participant a handheld amplifier (SuperEar SE9000) and provide instruction on device use and best-practices (i.e. reducing background noise) to improve communication for the patient-caregiver pairs.

Participant-caregiver pairs will utilize the device and communication strategies over a 4-6-week period between LVR visits. Upon return, pairs will complete semi-structured interviews to elicit information about utilization (successes, barriers), impact on communication, and open qualitative feedback. Participants and caregivers will complete post-intervention functioning questionnaire and Zarit Burden Interview, respectively.

Conditions

Dual Sensory Impairment of Vision and Hearing

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

SuperEar9000

Intervention Type: DEVICE

Handheld hearing amplifier, not FDA regulated.

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.

No interventions assigned to this group

Formal/Informal Caregivers

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

No interventions assigned to this group

Interventions

SuperEar9000

Handheld hearing amplifier, not FDA regulated.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Reed, AuD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Medicine

Locations

Low Vision Rehabilitation Clinic, Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

LVR-F-1

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00183648

Identifier Type: -

Identifier Source: org_study_id