NCT01846676已完成不适用
Assessment of the "Active Communication Education" Program for Audiological Rehabilitation in Patients With Hearing Loss Users of Hearing Aids
University of Chile1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2012年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Adherence to the use of hearing aids in elderly population with hearing loss
研究概览
简要总结
- Introduction: Hearing loss is a prevalent condition in elderly population. However, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In 2007 there was designed a rehabilitation program called ACE, which aims to improve rehabilitation directed to hearing aids users. The study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population.
- Objective: To evaluate the utility of a standardized counselling program in patients with hearing loss.
- Material and Methods: A before/after trial will be carried out, approved by the Hospital ethics - committee. Patients with 65 years and older with hearing loss diagnosed by pure tone audiometry will be included. To assess adherence we will use the IOI-HA scale.
详细描述
- Introduction: Hearing loss is a prevalent condition in elderly population. However, the low adherence to hearing aids is a fact, with an estimation of use of 50 per cent. In Chile, hearing aids are provided by the State for elderly population. In 2007 there was designed a rehabilitation program called Active Communication Education (ACE), that is a semistructured rehabilitation program for people with hearing loss, which aims to improve rehabilitation of hearing aids users by a strategy based on problem solution.
- The study hypothesis is that a counseling program will improve adherence to hearing aids in elderly population.
- Objective: To evaluate the utility of a standardized counseling program in patients with hearing loss.
- Material and Methods: A before/after clinical trial will be carried out, approved by the Hospital ethics - committee. Patients with 65 years and older diagnosed by pure tone audiometry who are beneficiaries of the Public GES hearing loss programme and receive a hearing aid will be included. The subjects will be randomized in two branches: Active branch, subject to the rehabilitation program; and passive branch, which was control, with usual management (no intervention). To assess adherence we will use the IOI-HA scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral hearing loss equal or higher than 40 decibels
- •Age 65 years old or more
- •Agree to be included in the study
- •Have a relative to go to the intervention with the subject
排除标准
- •Severe organic brain impairment
- •Physical or mental incapacity to understand the study questionnaires
- •Structural pathology of the ear that produces hearing loss as chronic otitis media, ear canal tumor, or tumor of the cerebellopontine angle
研究组 & 干预措施
Program counseling
Active Comparator
Active branch, subject to the rehabilitation program
干预措施: Active Communication Education Program (Behavioral)
No counseling
Placebo Comparator
Passive branch, which was control, with usual management (no intervention).
干预措施: Control (Other)
结局指标
主要结局
Adherence to the use of hearing aids in elderly population with hearing loss
时间窗: One year
次要结局
未报告次要终点
研究者
Felipe Cardemil
Otolaryngology department, University of Chile
University of Chile
研究点 (1)
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