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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742609
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Noor Afzarini Hasnita Binti Ismail, University of Manchester

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.

Condition or disease Intervention/treatment Phase
Written Information Written Info and Hearing Aid Reminder Written Info and Planning on Hearing Aid Use All Materials Other: ii) the reminder Other: ii) written behavioural plan Other: iv) all materials Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: A Randomised Controlled Trial of a Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit.
Actual Study Start Date : January 29, 2018
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

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.
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)

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.
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).

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
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.




Primary Outcome Measures :
  1. Hearing aid use [ Time Frame: 6-weeks ]
    Self-reported hearing aid use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742609


Locations
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United Kingdom
Audiology Clinic
Manchester, United Kingdom, M20 2LR
Sponsors and Collaborators
University of Manchester
Investigators
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Principal Investigator: Piers Dawes, Dr Manchester Centre for Audiology and Deafness,University of Manchester
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Responsible Party: Noor Afzarini Hasnita Binti Ismail, Principle Investigator, University of Manchester
ClinicalTrials.gov Identifier: NCT03742609    
Other Study ID Numbers: 234737
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No