A Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit
July 26, 2019 updated by: Noor Afzarini Hasnita Binti Ismail, University of Manchester
A Randomised Controlled Trial of a Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manchester, United Kingdom, M20 2LR
- Audiology Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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.
|
|
|
Active Comparator: 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.
|
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)
|
|
Active Comparator: 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.
|
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).
|
|
Experimental: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hearing aid use
Time Frame: 6-weeks
|
Self-reported hearing aid use
|
6-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Piers Dawes, Dr, Manchester Centre for Audiology and Deafness,University of Manchester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2018
Primary Completion (Actual)
December 30, 2018
Study Completion (Actual)
December 30, 2018
Study Registration Dates
First Submitted
November 13, 2018
First Submitted That Met QC Criteria
November 14, 2018
First Posted (Actual)
November 15, 2018
Study Record Updates
Last Update Posted (Actual)
July 30, 2019
Last Update Submitted That Met QC Criteria
July 26, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 234737
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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