NCT03912779

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

February 22, 2019

Last Update Submit

April 9, 2019

Conditions

Hearing Loss

Keywords

First time hearing aid user

Outcome Measures

Primary Outcomes (1)

  • 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).

    Change from Baseline self-efficacy for hearing aids up to 8 weeks

Secondary Outcomes (3)

  • Hearing aid self-efficacy using Ida Motivational Line Tools (Ida Institute, 2013)

    Change from Baseline self-efficacy for hearing aids up to 8 weeks

  • Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015)

    Up to 8 weeks

  • Readiness for hearing rehabilitation (action); Ida Motivational Line Tools Question 1 (Ida Institute, 2013)

    Change from Baseline readiness up to 8 weeks

Study Arms (2)

C2Hear RLOs

EXPERIMENTAL

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

Printed hearing aid booklet

PLACEBO COMPARATOR

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

Interventions

C2Hear RLOsBEHAVIORAL

Freely available online RLOs

C2Hear RLOs
Printed hearing aid bookletBEHAVIORAL

Departmental printed hearing aid booklet (standard care)

Printed hearing aid booklet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Melanie Ferguson

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Study Principal Investigator

Study Record Dates

First Submitted

February 22, 2019

First Posted

April 11, 2019

Study Start

November 11, 2016

Primary Completion

February 27, 2017

Study Completion

July 28, 2017

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share