Controlled Trial of the I-PLAN Intervention

Completed

• Conditions: Hearing Aid
• Interventions: Behavioral: I-PLAN

• Registration Number: NCT04017416
• Lead Sponsor: University of Manchester

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-07
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-11
• Last Update Submitted: 2019-07-11
• Study First Posted: 2019-07-12
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
I-PLAN	I-PLAN	Audiologists were instructed to deliver the I-PLAN in addition to standard care at the hearing aid fitting consultation.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Audiology Clinic; 🇬🇧 Manchester, United Kingdom