Improving Communication With Formal/Informal Caregivers Among Older Adults With Dual Sensory Impairment: Feasibility of Hearing Intervention in a Low Vision Rehabilitation Clinic Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Prevalence of Dual Sensory Impairment
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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
- •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 ≥
- •No participants are excluded based on race or sex.
结局指标
主要结局
Prevalence of Dual Sensory Impairment
时间窗: 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.
次要结局
- 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)