Controlled Trial of the I-PLAN Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Aid
• Intervention / Treatment: Behavioral: I-PLAN

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 Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M20 2LR
    • Audiology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study recruited adult patients who were first-time hearing aid users.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Care; 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; Audiologists were instructed to deliver the I-PLAN in addition to standard care at the hearing aid fitting consultation.	Behavioral: I-PLAN; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Manchester
• Investigators: Principal Investigator: Piers Dawes, PhD, Manchester Centre for Audiology and Deafness

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2018
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 17/NW/0406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No