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

All Materials Clinical Trial

Official title:

A Randomised Controlled Trial of a Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742609
• Other study ID #: 234737
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: July 2019
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• 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)
• 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).
• 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.

Locations

Country	Name	City	State
United Kingdom	Audiology Clinic	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing aid use	Self-reported hearing aid use	6-weeks