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临床试验/NCT03742609
NCT03742609已完成不适用

A Randomised Controlled Trial of a Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit.

University of Manchester2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年1月29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
入组人数
240
试验地点
2
主要终点
Hearing aid use

研究概览

简要总结

The aim of the present study is to test I-PLAN as a self-management tool to promote hearing aid use and benefit (measured by self-reported questionnaires and hearing aid data-logging) among new adult hearing aid patients via a randomised controlled trial compared to treatment as usual. We hypothesized that the I-PLAN will increase hearing aid use and reduce self-reported hearing difficulty via promoting hearing aid use habits and self-regulation with respect to hearing aid use.

详细描述

The aim of the present study is to test I-PLAN, an intervention designed to promote hearing aid use among adult hearing aid patients, for the first time. I-PLAN is the first intervention in audiology that has been developed using the behaviour change wheel. It consists of three components; i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Care Provider)

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

  • Aged 18 years old or above
  • Have never used a hearing aid before
  • Have good understanding of English
  • have sufficient mental capacity to provide informal consent based on audiologist's opinion

排除标准

  • Have inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
  • presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA, 2007)

研究组 & 干预措施

Information only

No Intervention

provision of written information regarding consequences of using a hearing aid and not using a hearing. For example using a hearing aid will improve ability to hear others.

Physical reminder only

Active Comparator

provision of written information regarding consequences of using a hearing aid and not using a hearing and physical reminder to use a hearing aid. For example, a hearing aid box as a physical reminder to use the hearing aids.

干预措施: ii) the reminder (Other)

Behaviour Plan only

Active Comparator

provision of written information regarding consequences of using a hearing aid and not using a hearing and creation of behaviour plan to use a hearing aid. For example, when and where to use the hearing aids.

干预措施: ii) written behavioural plan (Other)

Info, Reminder and Plan

Experimental

provision of written information regarding consequences of using a hearing aid and not using a hearing, physical reminder and creation of behaviour plan to use a hearing aid

干预措施: iv) all materials (Other)

结局指标

主要结局

Hearing aid use

时间窗: 6-weeks

Self-reported hearing aid use

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

Noor Afzarini Hasnita Binti Ismail

Principle Investigator

University of Manchester

研究点 (2)

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