An interventional study of Eriksholm Guide to Better Hearing in Hearing Loss, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-11.
Sponsored by University of Nottingham · Not applicable, Interventional, and Supportive care
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.
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
(II) Feasibility/acceptability of approach (Quantitative outcomes)
(III) Users' perspective/opinions of the intervention (Qualitative outcomes)
Participants views concerning what they like and dislike about the program (i.e.
acceptability)
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.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 83 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have either:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The 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.
Other: Eriksholm Guide to Better Hearing
Online rehabilitation program.
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).
Time frame: Change from Baseline following up to 5 weeks of independent use of the online intervention
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.
Time frame: Baseline and following up to 5 weeks of independent use of the online intervention
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.
Time frame: Baseline (Part 1 only) and following up to 5 weeks of independent use of the online intervention (Part 2 only)
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.
Time frame: Baseline and following up to 5 weeks of independent use of the online intervention
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).
Time frame: Baseline and following up to 5 weeks of independent use of the online intervention
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).
Time frame: Baseline and following up to 5 weeks of independent use of the online intervention
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.
Time frame: Baseline and following up to 5 weeks of independent use of the online intervention
Plan to share: No
Ran from Nov 2016 to primary completion in Mar 2018, 16 months.
Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's 16 months is below that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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