Hearing LossNCT03912779
Evaluation of Self-management Education in First Time Hearing Aid Users
A study testing C2Hear RLOs and Printed hearing aid booklet in people with Hearing Loss, run by Nottingham University Hospitals NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- C2Hear RLOs and Printed hearing aid booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2016to 28 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those unable to complete study questionnaires due to age-related problems (e.g. cognitive decline)
About this study
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
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.
Read the 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:
- 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
- Hearing Loss
- Being tested
- C2Hear RLOs, Printed hearing aid booklet
- Keywords
- First time hearing aid user
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2Hear RLOsBehavioural
Freely available online RLOs
Printed hearing aid bookletBehavioural
Departmental printed hearing aid booklet (standard care)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Printed hearing aid booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: Change from Baseline self-efficacy for hearing aids up to 8 weeks
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.
Measured: Up to 8 weeks
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).
Measured: Change from Baseline readiness up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start11 Nov 2016
- Primary completion27 Feb 2017
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Aston University
- Responsible party
- Principal investigator, Melanie Ferguson, Nottingham University Hospitals NHS Trust
- Investigators
- Melanie Ferguson, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912779
- Sponsor's protocol ID
- 16IH006
- Other IDs
- 168-2016-RGM
- Status last verified
- Apr 2019
- First submitted
- 22 Feb 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03912779
- Acronym / sponsor ID
- 16IH006
- Conditions
- Hearing Loss
- Keywords
- First time hearing aid user
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Aston University
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C2Hear RLOs | Experimental | Behavioral: C2Hear RLOsC2Hear 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. |
| Printed hearing aid booklet | Placebo comparator | Behavioral: Printed hearing aid bookletA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Those unable to complete study questionnaires due to age-related problems (e.g. cognitive decline)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C2Hear RLOsFreely available online RLOs | Behavioural | C2Hear RLOs |
| Printed hearing aid bookletDepartmental printed hearing aid booklet (standard care) | Behavioural | Printed hearing aid booklet |
Primary outcome
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).
3 secondary outcomes
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
Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Ferguson principal investigator
Nottingham University Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing C2Hear RLOs and Printed hearing aid booklet in people with Hearing Loss, run by Nottingham University Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.