Controlled Trial of the I-PLAN Intervention

Sponsor

University of Manchester (Other)

Overall Status

Completed

CT.gov ID

NCT04017416

Collaborator

(none)

160

Enrollment

Location

11.9

Actual Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Aid	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

160 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 2, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Objective hearing aid use [6 weeks]
Hearing aid use were measured from data-logging downloaded from hearing aid(s)
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-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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Audiology Clinic	Manchester		United Kingdom	M20 2LR

Sponsors and Collaborators

University of Manchester

Investigators

Principal Investigator: Piers Dawes, PhD, Manchester Centre for Audiology and Deafness

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noor Afzarini Hasnita Binti Ismail, Principle Investigator, University of Manchester

ClinicalTrials.gov Identifier:

NCT04017416

Other Study ID Numbers:

17/NW/0406

First Posted:

Jul 12, 2019

Last Update Posted:

Jul 12, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 12, 2019