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Completed

NCT Number: NCT04017416

Controlled Trial of the I-PLAN Intervention

That is a need for intervention to promote hearing aid use among adult patients with hearing aids. The aim of the present study was, for the first time, to evaluate the efficacy of the I-PLAN intervention to promote hearing aid use.

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Key information

Conditions

Hearing Aid

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Audiology Clinic

Manchester, M20 2LR, United Kingdom

About this study

The I-PLAN is a behaviour change theory-based intervention to promote hearing aid use. It consists of; 1. information on consequences of using and not using a hearing aid, 2. a physical prompt as a reminder to hearing aid use and 3. a behavioural plan to use a hearing aid. The aim of this study was to test efficacy of the I-PLAN intervention, delivered face-to-face by study audiologists. 160 first-time hearing aid users were recruited at the hearing aid fitting appointment. Adult patients were allocated either to the I-PLAN group or Standard Care group. Adult patients were allocated to the groups based on the clinic schedules of study audiologists.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • had no previous personal experience of using a hearing aid
  • were aged 18 years old or above
  • attended initial hearing aid fitting appointment with study audiologists
  • were native English speakers or had good understanding of English
  • had sufficient mental capacity to provide informed consent based on audiologist's opinion were eligible to take part in this study

Exclusion criteria

  • 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

I-PLAN

Behavioral

The I-PLAN is a behaviour change intervention that consists of; information on consequences of hearing aid use/non-use, reminder prompt and behavioural plan to promote hearing aid use.

Primary outcomes

  1. Subjective hearing aid use based on Glasgow Hearing Aid Benefit Profile questionnaire

    Time frame: 6 weeks

    Self-reported hearing aid use with 5 response options (1-never/not all to 5 - all the time). Total score 5.

Secondary outcomes

  1. Objective hearing aid use

    Time frame: 6 weeks

    Hearing aid use were measured from data-logging downloaded from hearing aid(s)

  2. International Outcome Inventory for Hearing Aids

    Time frame: 6 weeks

    Self-reported hearing aid benefit with five response options (from 1 to 5). Higher score indicate better outcomes

  3. Self-reported Hearing Handicap Inventory for the Elderly and for Adults - Screening version

    Time frame: 6 weeks

    Self-reported hearing aid benefit with three response options (yes- 4 points, sometimes- 2 points and no - 0 points). Higher scores indicate greater perceived hearing handicap

  4. Self-regulation in relation to hearing aid use

    Time frame: 6 weeks

    Self-reported self-regulation with a seven point Likert scale (1 strongly disagree to 7 strongly agree). Higher scores indicate greater self-regulation

  5. Habit formation

    Time frame: 6 weeks

    Self-reported habit formation with seven point Likert scale (1 strongly disagree to 7 strongly agree). Higher the scores indicate stronger habit

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

Controlled Trial of the I-PLAN Intervention to Promote Hearing Aid Use Among First Time Adult Hearing Aid Users

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2019
Registry last updated
Jul 12, 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.

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