Evaluation of the Effectiveness of a Rehabilitation Program for Hearing and Communication Disorders in Elderly People in Nursing Homes.

Официальное название

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)

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое use of hearing rehabilitation device
  the use hearing rehabilitation devices aimed to improve audibility

Первичные конечные точки

• effectiveness of the Hear2Share program [Срок оценки: every weeks from enrollment until end of participation at 15 weeks]

Вторичные конечные точки (1)

• wearing time of the device [Срок оценки: From enrollment to the end of participation at 15 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• University Hospital Toulouse — Toulouse

Идентификаторы

NCT: NCT07321691 · RC31/23/0390 · 2025-A01543-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗