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

NCT03742609 | Completed DMC

• 1 other identifier: 234737
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hearing aid use

  Self-reported hearing aid use

  6-weeks

Study Arms (4)

Information only

NO INTERVENTION

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.

Physical reminder only

ACTIVE COMPARATOR

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.

Other: ii) the reminder

Behaviour Plan only

ACTIVE COMPARATOR

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.

Other: ii) written behavioural plan

Info, Reminder and Plan

EXPERIMENTAL

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

Other: iv) all materials

Interventions

ii) the reminder 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)

Physical reminder only

ii) written behavioural plan 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).

Behaviour Plan only

iv) all materials 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.

Info, Reminder and Plan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have 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)

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Audiology Clinic

Manchester, M20 2LR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34999593 DERIVED

Study Officials

• Piers Dawes, Dr

  Manchester Centre for Audiology and Deafness,University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: January 29, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

GB (1)