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

April 9, 2019 updated by: Melanie Ferguson, Nottingham University Hospitals NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

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:

  • 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)

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline self-efficacy for hearing aids up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline self-efficacy for hearing aids up to 8 weeks
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.
Up to 8 weeks
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).
Change from Baseline readiness up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

Aston University

Investigators

  • Principal Investigator: Melanie Ferguson, Nottingham University Hospitals Nhs Trust

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)

November 11, 2016

Primary Completion (Actual)

February 27, 2017

Study Completion (Actual)

July 28, 2017

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 11, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16IH006
  • 168-2016-RGM (Other Identifier: Aston University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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