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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
C2Hear RLOs
Printed hearing aid booklet
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hearing Loss focused on measuring First time hearing aid user

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    C2Hear RLOs

    Printed hearing aid booklet

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids score (West and Smith, 2007)
    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

    Hearing aid self-efficacy using Ida Motivational Line Tools (Ida Institute, 2013)
    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).
    Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015)
    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.
    Readiness for hearing rehabilitation (action); Ida Motivational Line Tools Question 1 (Ida Institute, 2013)
    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).

    Full Information

    First Posted
    February 22, 2019
    Last Updated
    April 9, 2019
    Sponsor
    Nottingham University Hospitals NHS Trust
    Collaborators
    Aston University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03912779
    Brief Title
    Evaluation of Self-management Education in First Time Hearing Aid Users
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 11, 2016 (Actual)
    Primary Completion Date
    February 27, 2017 (Actual)
    Study Completion Date
    July 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nottingham University Hospitals NHS Trust
    Collaborators
    Aston University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss
    Keywords
    First time hearing aid user

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    C2Hear RLOs
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Printed hearing aid booklet
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    C2Hear RLOs
    Intervention Description
    Freely available online RLOs
    Intervention Type
    Behavioral
    Intervention Name(s)
    Printed hearing aid booklet
    Intervention Description
    Departmental printed hearing aid booklet (standard care)
    Primary Outcome Measure Information:
    Title
    Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids score (West and Smith, 2007)
    Description
    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).
    Time Frame
    Change from Baseline self-efficacy for hearing aids up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Hearing aid self-efficacy using Ida Motivational Line Tools (Ida Institute, 2013)
    Description
    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).
    Time Frame
    Change from Baseline self-efficacy for hearing aids up to 8 weeks
    Title
    Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015)
    Description
    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.
    Time Frame
    Up to 8 weeks
    Title
    Readiness for hearing rehabilitation (action); Ida Motivational Line Tools Question 1 (Ida Institute, 2013)
    Description
    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).
    Time Frame
    Change from Baseline readiness up to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melanie Ferguson
    Organizational Affiliation
    Nottingham University Hospitals NHS Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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