Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes: a Single Case Experimental Design (N of 1 Trials Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- effectiveness of the Hear2Share program
研究概览
简要总结
In France, 64% of residents in nursing homes have moderate to severe hearing loss and only 12% are treated with hearing aids. Yet the extra-auditory consequences of presbycusis are numerous: general fatigue, isolation, anxiety and depression. France counted 620 000 nursing home beds in 2020 and this number increases each year by an average of 2% (DREES (Department of Research, Studies, Evaluation and Statistics), France, 2019). Only few studies have focused on hearing disorders in this population, given the importance of their communication difficulties (Solheim J et al., 2016, Kimball A et al., 2017 ). The population in nursing homes is for 80% over 80 years old (DREES (Department of Research, Studies, Evaluation and Statistics) survey, France, 2014). This same survey looked at the proportion of people with functional hearing limitations and their severity depending on where they live. The highest rates were found among people living in institutions (regardless of the degree of functional hearing limitations), with 42% of people living in nursing homes and senior residences who have hearing functional limitations against 15.9 % of those living at home The present study is interested in the management of hearing and communication disorders in nursing homes residents by setting up a program for the rehabilitation of these disorders, based on the use of a simple hearing device by the nursing home staff.
详细描述
The main objective of this study is to assess the effectiveness of a rehabilitation program for hearing and communication disorders intended to improve the communication of residents in nursing homes.
This program includes for the resident:
- the alternative use of two hearing rehabilitation devices aimed to improve audibility
- An inaugural training led by a trained professional to promote oral communication The effectiveness of the two devices will be compared.
This program includes for the staff members:
- A one-day training comprising three components (general concepts concerning deafness and its rehabilitation, training in the use of the device to improve audibility, training in facilitating the communication workshop).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •residents in nursing homes with hearing impairment (HHIE-S (Hearing Handicap Inventory for the Elderly Screening and pure tone audiometry)
- •with an MMS (Mini Mental State) score> 15
- •with a GIR Group ≥ à 3 affiliated to a social security scheme
- •French speaking
排除标准
- •wearing any type of hearing aid at the time of inclusion
- •having followed a similar training program
- •Subjects under juridical protections or tutelage measure
- •unable to answer questions and participate in group activities
- •with associated life-threatening pathologies and/or a life expectancy in EHPAD of less than 6 months
研究组 & 干预措施
transmitter with receiver
hearing rehabilitations : a transmitter with several receivers
干预措施: use of hearing rehabilitation device (Other)
listening assistant.
one type of hearing rehabilitations
干预措施: use of hearing rehabilitation device (Other)
No hearing device
no hearing device
结局指标
主要结局
effectiveness of the Hear2Share program
时间窗: every weeks from enrollment until end of participation at 15 weeks
The primary outcome will be the effectiveness of the Hear2Share program evaluated by the Percentage of words correctly identified at 60 dB HL measured every weeks
effectiveness of the Hear2Share program
时间窗: every weeks from enrollment until end of participation at 15 weeks
The primary outcome will be the effectiveness of the Hear2Share program evaluated by the Percentage of words correctly identified at 60 dB HL measured every weeks
次要结局
- wearing time of the device(From enrollment to the end of participation at 15 weeks)
- wearing time of the device(From enrollment to the end of participation at 15 weeks)