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临床试验/NCT04673565
NCT04673565Enrolling By Invitation不适用

A Randomized Controlled Trial Evaluating the Effects of Motivational Interviewing in New Hearing Aid Users

University of British Columbia1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
180
试验地点
1
主要终点
Hearing aid use hours

研究概览

简要总结

Hearing loss is one of the most common chronic disabilities in the older adult population and affects their quality of life. Hearing aid use can improve one's quality of life by increasing a person's ability to detect, differentiate and locate sound, and improve speech recognition. Several factors seem to reduce motivation to use a hearing aid. Fears of exclusion and shame due to hearing loss are major deterrents to hearing aid use. Motivational interviewing (MI) is a counselling style aimed at creating desire in patients to change their behavior.

There have been pilot studies that suggest one-on-one MI can increase hearing aid use, but other pilot studies found the reverse hence the evidence is inconclusive. The effectiveness of group MI therapy is also being investigated in MI research. While results in group MI research are promising, studies investigating group MI have been limited to substance abuse.

详细描述

Hearing loss is one of the most common chronic disabilities in the older adult population and affects their quality of life. Hearing aid use can improve one's quality of life by increasing a person's ability to detect, differentiate and locate sound, and improve speech recognition. Several factors seem to reduce motivation to use a hearing aid. Fears of exclusion and shame due to hearing loss are major deterrents to hearing aid use. MI is a counselling style aimed at creating desire in the patient to change their behavior.

To our knowledge, there have been no studies that investigated the impact of group MI on hearing aid use.

Hypothesis Standard care with motivational interviewing in a group setting does not alter the hearing aid usage when compared to the standard care alone in the new hearing aid users.

Study Methodology

Trial Objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The study will be a multi-center, prospective, randomized patient-blind controlled trial and employ a between-subject, pretest-posttest design.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years and older
  • New hearing aid user
  • Unilateral or bilateral hearing threshold above 25 dB in the worse ear (based on four-frequency PTA across 0.5, 1, 2 and 4 kHz, high-frequency PTA across 3, 4, 6, and 8 kHz, and low-frequency PTA across 0.5, 1 and 2 kHz)

排除标准

  • History of hearing aid use
  • Do not understand the English language
  • Unable to complete the online questionnaires in English language
  • Have inconsistent pure-tone audiometric readings
  • Have medical constraints that prohibit them from wearing hearing aids

结局指标

主要结局

Hearing aid use hours

时间窗: Study assessments will be performed during the initial visit, and at 1, 3, 6 and 12-month time points.

Differences in hearing aid use hours will be measured at each time point

Patient reported outcomes

时间窗: Study assessments will be performed during the initial visit, and at 1, 3, 6 and 12-month time points.

International Outcome Inventory for Hearing Aids questionnaire (Cox \& Alexander, 2002) at each time point.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Desmond A Nunez

Principal Investigator

University of British Columbia

研究点 (1)

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