Dual Sensory Impairment Low Vision Rehabilitation (LVR) Initiative (LVR)
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|ClinicalTrials.gov Identifier: NCT03664349|
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : April 19, 2019
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
|Condition or disease||Intervention/treatment|
|Dual Sensory Impairment of Vision and Hearing||Device: SuperEar9000|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Improving Communication With Formal/Informal Caregivers Among Older Adults With Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic Pilot|
|Actual Study Start Date :||November 26, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
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.
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.
Identified persons who assist willing and eligible older adult pilot participants with two or more ADLs/IADLs.
- Prevalence of Dual Sensory Impairment [ Time Frame: 1 day ]
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.
- 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) [ Time Frame: 1 day ]
Caregivers defined as identified people who assist with two or more ADLs/IADLs). Impact measured by a 12 item Zarit Burden Interview Questionnaire(ZBI-12) to assess burden of care. Total ZBI-12 score: summation of 12 items (0 to 4 points per item, total score range 0 to 48).
- 0-10: no to mild burden
- 10-20: mild to moderate burden
- >20: high burden
- Feasibility of Handheld Amplifier on Communication with Formal/Informal Caregivers as assessed by Semi Structured Interviews [ Time Frame: 4-6 Weeks ]Feasibility will be measured by semi-structured dyad interviews conducted with formal/informal caregiver and older adult participant pairs. Feasibility will then be determined qualitatively based on participants' response to the interview questions.
- Impact of Handheld Amplifier on Caregiver Burden with Formal/Informal Caregivers as assessed by Zarit Burden Interview Questionnaire [ Time Frame: 4-6 Weeks ]
Impact of hearing amplifier on dyad caregiver burden will be measured with ZBI-12. Total ZBI-12 score: summation of 12 items (0 to 4 points per item, total score range 0 to 48).
- 0-10: no to mild burden
- 10-20: mild to moderate burden
- >20: high burden
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664349
|Contact: Nick Reed, AuDfirstname.lastname@example.org|
|United States, Maryland|
|Low Vision Rehabilitation Clinic, Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Nicholas S Reed, Aud. 410-502-4331 email@example.com|
|Principal Investigator:||Nick Reed, AuD||Johns Hopkins Bloomberg School of Medicine|