Controlled Trial of the I-PLAN Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hearing Aid

Intervention / Treatment
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* Behavioral: I-PLAN


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Care<br>Audiologists in the standard care group were instructed to manage the patients in the same way as they would do in their routine clinics which were in accordance with national practice guidelines and were typical of National Healthcare Services (NHS) audiology departments across the UK. | |
| I-PLAN<br>Audiologists were instructed to deliver the I-PLAN in addition to standard care at the hearing aid fitting consultation. | Behavioral: I-PLAN<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective hearing aid use based on Glasgow Hearing Aid Benefit Profile questionnaire | Self-reported hearing aid use with 5 response options (1-never/not all to 5 - all the time). Total score 5. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective hearing aid use | Hearing aid use were measured from data-logging downloaded from hearing aid(s) | 6 weeks | 
| International Outcome Inventory for Hearing Aids | Self-reported hearing aid benefit with five response options (from 1 to 5). Higher score indicate better outcomes | 6 weeks | 
| Self-reported Hearing Handicap Inventory for the Elderly and for Adults - Screening version | 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 | 6 weeks | 
| Self-regulation in relation to hearing aid use | Self-reported self-regulation with a seven point Likert scale (1 strongly disagree to 7 strongly agree). Higher scores indicate greater self-regulation | 6 weeks | 
| Habit formation | Self-reported habit formation with seven point Likert scale (1 strongly disagree to 7 strongly agree). Higher the scores indicate stronger habit | 6 weeks |