Evaluation of Self-management Education in First Time Hearing Aid Users
NCT ID: NCT03912779
Last Updated: 2019-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
56 participants
INTERVENTIONAL
2016-11-11
2017-07-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
mHealth Technologies for Hearing Aid Users
NCT03136718
Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids
NCT06560918
A Self-Affirmation Intervention to Promote Hearing Aid Use
NCT04382703
A Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit
NCT03742609
Applying the Use of Motivational Tools to Auditory Rehabilitation
NCT01843777
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
C2Hear RLOs
Freely available online RLOs
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.
Printed hearing aid booklet
Departmental printed hearing aid booklet (standard care)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
C2Hear RLOs
Freely available online RLOs
Printed hearing aid booklet
Departmental printed hearing aid booklet (standard care)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aston University
OTHER
Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Melanie Ferguson
Associate Professor, Study Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Melanie Ferguson
Role: PRINCIPAL_INVESTIGATOR
Nottingham University Hospitals NHS Trust
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
168-2016-RGM
Identifier Type: OTHER
Identifier Source: secondary_id
16IH006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.