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Hearing LossNCT03408535

Feasibility of an Online Rehabilitation Program

A study testing Eriksholm Guide to Better Hearing in people with Hearing Loss, run by University of Nottingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will assess the feasibility of conducting a full-scale clinical trial of the effectiveness of an online rehabilitation program for adults living with hearing loss. The program aims to help people use their hearing aid(s) and interact in social settings more effectively. 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?
Eriksholm Guide to Better Hearing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteUnited Kingdom
Study dates
1 Nov 2016to 30 Apr 2018
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

  • Ability to give informed consent
  • English as first spoken language or good understanding of English.
  • Adults aged ≥18 years (no upper age limit)
  • Mild-to-moderate hearing loss (average hearing threshold across octave frequencies 0.25-4kHz ≥20 and ≤70dB HL)
  • Have either:
  • Used hearing aids for at least one year (existing hearing aid users), or
  • Have not used hearing aids or an alternative form of amplification (e.g. personal sound amplification products) within the past two years (first-time hearing aid users)
  • Access the Internet and compatible device (e.g. computer or tablet device).

Who cannot join

  • Report having severe tinnitus
  • Diagnosis of Ménière's disease
  • Patients who are unable to complete the questionnaires without assistance due to age- related problems such as cognitive decline and dementia.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre

    Nottingham, Non-US/Non-Canadian, NG1 5DU

Other trials in United Kingdom

About this study

Official title: Assessing the Feasibility of a Clinical Trial of an Online Audiological Rehabilitation Program

The study will assess the feasibility of conducting a full-scale clinical trial of the effectiveness of an online rehabilitation program for adults living with hearing loss. The program aims to help people use their hearing aid(s) and interact in social settings more effectively. The program is made up of 5 modules that cover different topics, such as hearing aids, communication strategies, and relaxation techniques.

Read the detailed description

STUDY PURPOSE

This feasibility study is a precursor of a randomised controlled trial (RCT) that will evaluate the effectiveness of an English-speaking version of the online program originally evaluated by Thorén et al in adult hearing aid users. This study will estimate a number of parameters necessary for the robust design of an RCT. This systematic approach of completing a feasibility study prior to a full-scale evaluation is strongly advocated by the Medical Research Council (MRC) guidelines for developing and evaluating complex interventions, ensuring that any uncertainties are addressed and that the intervention operates as intended.

OBJECTIVES

This study will be used to estimate the following parameters:

(I) Recruitment

  1. Willingness of clinicians to recruit participants
  2. Willingness of participants to consent
  3. Number of eligible patients. (II) Feasibility/acceptability of approach (Quantitative outcomes)
  4. Characteristics of the outcome measures
  5. Standard deviation of outcome measures to estimate sample size
  6. Follow-up rates, response rates to questionnaires, adherence/compliance rates
  7. Time needed to collect and analyse data. (III) Users' perspective/opinions of the intervention (Qualitative outcomes)
  8. Participant's views regarding delivery of the program through different devices
  9. How the program is used and how often (i.e. usability)
  10. Participants views concerning what they like and dislike about the program (i.e. acceptability)
  11. How much of the program is completed (adherence).

STUDY CONFIGURATION

A single-centre feasibility study of a clinical study with one arm (intervention-only). A before and after intervention design will be used. A sub-group of participants will take part in a qualitative follow-up session.

Primary endpoint. In accordance with objective (II) feasibility/acceptability of approach, follow-up measures will be recorded upon completion of the last intervention module

Secondary endpoint. In accordance with objective (III) users' perspective/opinions of the intervention, completion of focus groups.

Participant Duration. Participants will take part in an initial assessment, which is estimated to last 1.5 hours. After completing the weekly online modules from home, participants will then take part in a follow-up assessment which will last up to 1.5 hours. A sub-sample of 16 participants will also be invited to take part focus groups lasting 1.5 hours (end of the study).

Recruitment. Existing hearing aid users will be identified from the National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC) Otology and Hearing Group's participant database. Participants in this database have provided consent to be approached about future research studies.

First-time hearing aid users will be recruited from publically funded National Health Service (NHS) Adult Audiology Departments in the East Midlands, UK.

All participants who express an interest in the study will receive a participant information sheet, alongside a pre-paid, addressed envelope in which to return their response if they choose to take part.

STATISTICS

Methods. The study data will be analysed by the research team at the NIHR Nottingham BRC. All data will be analysed on University of Nottingham computers and backed up to the University of Nottingham servers. Data will be analysed using STATA version 14. Continuous data will be summarised using means and standard deviations, whereas categorical data will be summarised using percentages. For each measure, the difference between baseline and follow-up will be examined using a paired samples t-test or Wilcoxon signed rank test. Medians and quartiles will be reported for non-parametric data, and means, standard deviations and 95% confidence intervals for parametric data. Statistical significance will be set at p=.05. As outcome data will be collected after the intervention period, no interim analyses will be performed.

Sample size and justification. The sample size estimate is based on the difference between two dependent means; baseline and follow-up. An a priori sample size calculation (G*power v.3.0.10) based on a medium effect size (Cohen's d=0.5), a one-sided Type I error rate of 5%, and 80% power, revealed that a sample size of 27 participants will be required for each sample (first-time and existing hearing aid users).

Assessment of efficacy. This is a feasibility study of a clinical study and, as such, will not assess the efficacy of the online rehabilitation program.

Conditions
Hearing Loss
Being tested
Eriksholm Guide to Better Hearing
Keywords
eHealth, Online Rehabilitation, Hearing Problems, Adult, Hearing Aids
Medical subject headings
Hearing Loss, Hearing Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eriksholm Guide to Better HearingOther

    Online rehabilitation program.

Study groups in NCT03408535
Study groupRoleWhat they receive
Eriksholm Guide to Better HearingOtherThe Eriksholm Guide to Better Hearing is an online rehabilitation program. The program is made up of 5-weekly modules that cover different topics. Each module includes self-studies, training, and professional video coaching in hearing loss, hearing aids, and communication strategies.
Receives: Other: Eriksholm Guide to Better Hearing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hearing Handicap Inventory for the Elderly (HHIE: Ventry & Weinstein, 1982)

    A 25-item questionnaire designed to assess the effects of hearing loss on the emotional (n = 13), and social/situational adjustment (n = 12) of older people, scored using a three-point scale (4 = yes; 2 = sometimes; 0 = no).

    Measured: Change from Baseline following up to 5 weeks of independent use of the online intervention

Secondary outcomes (6)

  1. International Outcome Inventory for Hearing Aids (IOI-HA: Cox & Alexander, 2002)

    A seven-item questionnaire (use, benefit, residual activity limitation, satisfaction, residual participation restriction, importance to others, quality of life) and is scored on a five-point scale.

    Measured: Baseline and following up to 5 weeks of independent use of the online intervention

  2. Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999)

    Assesses hearing disability (or activity limitations) and handicap (or participation restrictions; part 1), and hearing aid use, benefit, residual disability and satisfaction (part 2). Each domain is measured on a five-point scale.

    Measured: Baseline (Part 1 only) and following up to 5 weeks of independent use of the online intervention (Part 2 only)

  3. Social Participation Restrictions Questionnaire (SPaRQ: Heffernan et al., 2016)

    A 19-item inventory that assesses social behaviours (9-items) and perceptions (10-items) in adults with mild-to-moderate hearing loss. Each item is measured on an 11-point response scale ranging from 'Completely Disagree' at point zero to 'Completely Agree' at point ten.

    Measured: Baseline and following up to 5 weeks of independent use of the online intervention

  4. Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (MARS-HA: West & Smith, 2007)

    Includes four subscales: basic handling, advanced handling, adjustment to hearing aids, and aided listening skills. Respondents indicate how confident they are that they could do the things described on an 11-point scale (0%=cannot do this, to 100%=certain I can do this).

    Measured: Baseline and following up to 5 weeks of independent use of the online intervention

  5. Practical Hearing Aid Skills Test (PHAST: Desjardins & Doherty, 2009)

    Tests eight hearing aid skills (insertion, removal, opening battery door, changing the battery, cleaning the aid, manipulating the voice clarity (VC), telephone use, and use of programs). Each skill was scored on a five-point Likert scale (0=cannot perform, 4=excellent).

    Measured: Baseline and following up to 5 weeks of independent use of the online intervention

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

    A 20-item open-ended questionnaire that measures free recall of knowledge relevant to practical (n = 12) and psychosocial (n = 8) issues on hearing aids and communication.

    Measured: Baseline and following up to 5 weeks of independent use of the online intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2018
  2. Study start1 Nov 2016
  3. Primary completion21 Mar 2018
  4. Study completion30 Apr 2018

Resources

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
Not applicable
Intervention model
Single group
Model description
A single-centre feasibility study of a clinical study with one arm (intervention-only). A before and after intervention design will be used. A sub-group of participants will take part in a qualitative follow-up session.
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03408535
Sponsor's protocol ID
RGS 16086
Other IDs
IRAS Project id: 214225, 16IH008
Status last verified
Jan 2018
First submitted
16 Jan 2018
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thoren ES, Oberg M, Wanstrom G, Andersson G, Lunner T. A randomized controlled trial evaluating the effects of online rehabilitative intervention for adult hearing-aid users. Int J Audiol. 2014 Jul;53(7):452-61. doi: 10.3109/14992027.2014.892643. Epub 2014 Apr 22.

    PubMed 24749664

  • Thoren E, Svensson M, Tornqvist A, Andersson G, Carlbring P, Lunner T. Rehabilitative online education versus internet discussion group for hearing aid users: a randomized controlled trial. J Am Acad Audiol. 2011 May;22(5):274-85. doi: 10.3766/jaaa.22.5.4.

    PubMed 21756843

  • Ventry IM, Weinstein BE. The hearing handicap inventory for the elderly: a new tool. Ear Hear. 1982 May-Jun;3(3):128-34. doi: 10.1097/00003446-198205000-00006.

    PubMed 7095321

  • Cox RM, Alexander GC. The International Outcome Inventory for Hearing Aids (IOI-HA): psychometric properties of the English version. Int J Audiol. 2002 Jan;41(1):30-5. doi: 10.3109/14992020209101309.

    PubMed 12467367

  • Gatehouse S. Glasgow Hearing Aid Benefit Profile: Derivation and validation of client-centred outcome measures for hearing aid services. J Am Acad Audiol. 1999;10(2):80-103.

  • Heffernan E, Coulson N, Henshaw H, Barry J, Ferguson MA. The development of a measure of participation in adults with hearing loss: a qualitative study of expert views. Trials. 2015;16(Suppl 1):30.

  • West RL, Smith SL. Development of a hearing aid self-efficacy questionnaire. Int J Audiol. 2007 Dec;46(12):759-71. doi: 10.1080/14992020701545898.

    PubMed 18049965

  • Desjardins JL, Doherty KA. Do experienced hearing aid users know how to use their hearing AIDS correctly? Am J Audiol. 2009 Jun;18(1):69-76. doi: 10.1044/1059-0889(2009/08-0022). Epub 2009 Apr 20.

    PubMed 19380509

  • Ferguson M, Brandreth M, Brassington W, Wharrad H. Information Retention and Overload in First-Time Hearing Aid Users: An Interactive Multimedia Educational Solution. Am J Audiol. 2015 Sep;24(3):329-32. doi: 10.1044/2015_AJA-14-0088.

    PubMed 26649541

  • Medical Research Council. Developing and evaluating complex interventions: new guidance. 2006. Retrieved from: https://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/.

Questions about this trial

What is this clinical trial studying?

A study testing Eriksholm Guide to Better Hearing in people with Hearing Loss, run by University of Nottingham at 1 site in United Kingdom.

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 8 inclusion and 3 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 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Hearing Handicap Inventory for the Elderly (HHIE: Ventry & Weinstein, 1982) (time frame: Change from Baseline following up to 5 weeks of independent use of the online intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03408535, which also lists 10 linked publications.

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 Oct 2018.

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