A Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit

NCT ID: NCT03742609

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-29

Study Completion Date

2018-12-30

Brief Summary

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The aim of the present study is to test I-PLAN as a self-management tool to promote hearing aid use and benefit (measured by self-reported questionnaires and hearing aid data-logging) among new adult hearing aid patients via a randomised controlled trial compared to treatment as usual. We hypothesized that the I-PLAN will increase hearing aid use and reduce self-reported hearing difficulty via promoting hearing aid use habits and self-regulation with respect to hearing aid use.

Detailed Description

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The aim of the present study is to test I-PLAN, an intervention designed to promote hearing aid use among adult hearing aid patients, for the first time. I-PLAN is the first intervention in audiology that has been developed using the behaviour change wheel. It consists of three components; i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.

Conditions

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Written Information Written Info and Hearing Aid Reminder Written Info and Planning on Hearing Aid Use All Materials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Information only

provision of written information regarding consequences of using a hearing aid and not using a hearing. For example using a hearing aid will improve ability to hear others.

Group Type NO_INTERVENTION

No interventions assigned to this group

Physical reminder only

provision of written information regarding consequences of using a hearing aid and not using a hearing and physical reminder to use a hearing aid. For example, a hearing aid box as a physical reminder to use the hearing aids.

Group Type ACTIVE_COMPARATOR

ii) the reminder

Intervention Type OTHER

Participants assigned to the prompt group were received instruction to use their hearing aid box as a physical prompt to remind participants to use their hearing aid(s)

Behaviour Plan only

provision of written information regarding consequences of using a hearing aid and not using a hearing and creation of behaviour plan to use a hearing aid. For example, when and where to use the hearing aids.

Group Type ACTIVE_COMPARATOR

ii) written behavioural plan

Intervention Type OTHER

Participants assigned to this group were received instruction to create at least one written plan for hearing aid use. Specifically, participants were asked to plan where and when to use their hearing aid(s).

Info, Reminder and Plan

provision of written information regarding consequences of using a hearing aid and not using a hearing, physical reminder and creation of behaviour plan to use a hearing aid

Group Type EXPERIMENTAL

iv) all materials

Intervention Type OTHER

i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.

Interventions

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ii) the reminder

Participants assigned to the prompt group were received instruction to use their hearing aid box as a physical prompt to remind participants to use their hearing aid(s)

Intervention Type OTHER

ii) written behavioural plan

Participants assigned to this group were received instruction to create at least one written plan for hearing aid use. Specifically, participants were asked to plan where and when to use their hearing aid(s).

Intervention Type OTHER

iv) all materials

i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 years old or above
2. Have never used a hearing aid before
3. Have good understanding of English
4. have sufficient mental capacity to provide informal consent based on audiologist's opinion

Exclusion Criteria

1. Have inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
2. presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA, 2007)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Noor Afzarini Hasnita Binti Ismail

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Piers Dawes, Dr

Role: PRINCIPAL_INVESTIGATOR

Manchester Centre for Audiology and Deafness,University of Manchester

Locations

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Audiology Clinic

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Ismail AH, Armitage CJ, Munro KJ, Marsden A, Dawes PD. Evaluation of the I-PLAN Intervention to Promote Hearing Aid Use in New Adult Users: a Randomized Controlled Trial. Ear Hear. 2022 Jul-Aug 01;43(4):1103-1113. doi: 10.1097/AUD.0000000000001195. Epub 2022 Jan 6.

Reference Type DERIVED
PMID: 34999593 (View on PubMed)

Other Identifiers

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234737

Identifier Type: -

Identifier Source: org_study_id

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