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Evaluation of Self-management Education in First Time Hearing Aid Users

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ClinicalTrials.gov Identifier: NCT03912779
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Aston University
Information provided by (Responsible Party):
Melanie Ferguson, Nottingham University Hospitals NHS Trust

Brief Summary:

The study will assess the impact of a hearing aid self-management intervention in first time hearing aid users compared to standard hearing aid self-management. Namely, the C2Hear multimedia videos, or Reusable Learning Objects (RLOs) will be used as the self-management intervention. A departmental hearing aid booklet (standard clinical care) will be used as the control intervention.

The study will determine the role of these RLOs in self-efficacy for hearing aid(s), hearing aid knowledge and readiness for action compared with standard hearing aid self-management education (hearing aid booklet) in groups of first time hearing aid users. Both groups will receive the education at the earliest audiology appointment (hearing assessment), helping to distinguish any impact of earlier education delivery.


Condition or disease Intervention/treatment Phase
Hearing Loss Behavioral: C2Hear RLOs Behavioral: Printed hearing aid booklet Not Applicable

Detailed Description:

Research question: To assess the role of interactive hearing aid self-management education on self-efficacy for hearing aid(s), readiness for action and hearing aid knowledge in first time hearing aid users.

Objectives:

Primary research question:

- Does the early delivery of interactive hearing aid self-management education improve self-efficacy for hearing aid(s) compared with standard care in first-time hearing aid users?

Secondary research questions:

i. Does the early delivery of interactive hearing aid self-management education improve readiness for hearing aids (their chosen intervention) compared with standard care in first-time hearing aid users?

ii. Does the early delivery of interactive hearing aid education improve hearing aid knowledge compared with standard care in first-time hearing aid users?

Study design:

A single centre, prospective study with two randomised arms; intervention group (access to RLOs in DVD/ or online format, patients' preference) and control (standard hearing aid education booklet).

Prospective first-time hearing aid users will be invited to take part in the study at hearing assessment, where they will be randomised to either the control or intervention group. Following 6-8 weeks of independent use prior to receiving hearing aids, study investigators will assess the impact of each education type on individuals self-efficacy for hearing aids, readiness for action and hearing aid knowledge.

Comparisons will be made to previous evaluation of the RLOs to allow exploration of the impact of earlier hearing aid self-management education on self-report measures.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Role of Interactive Hearing Aid Self-management Education on Self-efficacy for Hearing Aid(s), Readiness for Action and Hearing Aid Knowledge in First Time Hearing Aid Users
Actual Study Start Date : November 11, 2016
Actual Primary Completion Date : February 27, 2017
Actual Study Completion Date : July 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
Experimental: C2Hear RLOs
C2Hear RLOs (https://www.youtube.com/C2HearOnline): nine (custom earmould) or eight (open fit hearing aid) multi-media learning clips covering practical and psychosocial components of owning a hearing aid, alongside user testimonials (n= 7). Participants asked to watch all relevant to their prospective hearing aid coupling (custom earmould or open fit), with no limit on number of views. A paper diary documented usage during the study duration.
Behavioral: C2Hear RLOs
Freely available online RLOs

Placebo Comparator: Printed hearing aid booklet
A 32-page printed A5 colour booklet, designed and written by local Audiology staff, supplied to all prospective hearing aid owners at the study centre as standard care. Same booklet supplied irrespective of hearing aid style (custom/open fit). All content conveyed via text and supporting pictures only. Participants assigned to the placebo comparator were asked to read the booklet once. A paper diary documented usage during the study duration.
Behavioral: Printed hearing aid booklet
Departmental printed hearing aid booklet (standard care)




Primary Outcome Measures :
  1. Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids score (West and Smith, 2007) [ Time Frame: Change from Baseline self-efficacy for hearing aids up to 8 weeks ]
    Self-reported self-efficacy for hearing aid(s) measured across four-subscales (Basic/advanced handling, adjustment to hearing aids and aided listening). Participants rank confidence in the tasks/behaviours described using an 11-point scale (0%=cannot do this, to 100%=certain I can do this).


Secondary Outcome Measures :
  1. Hearing aid self-efficacy using Ida Motivational Line Tools (Ida Institute, 2013) [ Time Frame: Change from Baseline self-efficacy for hearing aids up to 8 weeks ]
    Self-report hearing aid self-efficacy (Ida Line Tool Question 2) determines participants perceived confidence in their ability to use hearing aid(s) using an 11-point visual analogue scale (0 = not at all confident, to 10= very much confident).

  2. Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015) [ Time Frame: Up to 8 weeks ]
    A 20-item open-ended questionnaire that measures free recall of hearing aid knowledge relevant to practical (n = 12) and psychosocial (n = 8) issues on hearing aids and communication. One point is allocated to each correct response, resulting in a percentage correct for each score. Maximum correct scores are 54; 32 points for practical subscale and 22 points for psychosocial subscale. Higher percentage values represent better knowledge.

  3. Readiness for hearing rehabilitation (action); Ida Motivational Line Tools Question 1 (Ida Institute, 2013) [ Time Frame: Change from Baseline readiness up to 8 weeks ]
    Self-report readiness for hearing rehabilitation (action) (Ida Line Tool Question 1) determines participants readiness to use hearing aid(s) using an 11-point visual analogue (0 = not at all important, to 10= very much important).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged > 18 years
  • Prospective first-time hearing aid users (defined as no hearing aid use in the last 2 years)
  • English as their spoken language or good understanding of English

Exclusion Criteria:

  • Those unable to complete study questionnaires due to age-related problems (e.g. cognitive decline)

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): NCT03912779


Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Aston University
Investigators
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Principal Investigator: Melanie Ferguson Nottingham University Hospitals NHS Trust

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Responsible Party: Melanie Ferguson, Associate Professor, Study Principal Investigator, Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03912779     History of Changes
Other Study ID Numbers: 16IH006
168-2016-RGM ( Other Identifier: Aston University )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melanie Ferguson, Nottingham University Hospitals NHS Trust:
First time hearing aid user
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms