Low Vision Rehabilitation Clinic, Johns Hopkins
Baltimore, Maryland, 21205, United States
NCT Number: NCT03664349
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
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Notify Me60 year and older
All sexes
Observational
Baltimore, Maryland, 21205, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Older Adult Participants
To be eligible for aims 1 & 2 of the study, older adult participants must meet all of the following criteria:
To be eligible for aim 3 of the study, older adult participants must meet the following additional criteria:
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:
Exclusion criteria
Potential candidates for enrollment who meet one or more of the following criteria are excluded from participation in the study:
Handheld hearing amplifier, not FDA regulated.
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.
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).
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.
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).
Johns Hopkins University
Other
Improving Communication With Formal/Informal Caregivers Among Older Adults With Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic Pilot
Acronym: LVR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.