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Completed

NCT Number: NCT03742609

A Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit

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.

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Key information

Conditions

Written Information All Materials Written Info and Hearing Aid Reminder Written Info and Planning on Hearing Aid Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Audiology Clinic

Manchester, M20 2LR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

ii) the reminder

Other

Participants assigned to the prompt group were received instruction to use their hearing aid box as a physical prompt to remind participants to use their hearing aid(s)

ii) written behavioural plan

Other

Participants assigned to this group were received instruction to create at least one written plan for hearing aid use. Specifically, participants were asked to plan where and when to use their hearing aid(s).

iv) all materials

Other

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.

Primary outcomes

  1. Hearing aid use

    Time frame: 6-weeks

    Self-reported hearing aid use

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2018
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.