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
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COMPLETED
94 participants
OBSERVATIONAL
2017-04-01
2018-10-24
Brief Summary
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Detailed Description
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Objectives: To establish the feasibility of the intervention by evaluating delivery, accessibility, usability, acceptability, and adherence in first-time hearing aid users. To establish suitable outcome measures to evaluate the effectiveness of the intervention in a future randomised controlled trial.
Study Design: Single centre, feasibility.
Naïve first-time hearing aid users will try out the intervention away from the laboratory. Following 10-12 weeks of independent use, the investigators will assess how the participants used the intervention using a mixed-methods approach across two parallel stages:
Stage 1. The investigators will assess the feasibility of the intervention in first-time hearing aid users, who will be invited to take part in semi-structured interviews. Using the COM-B model (Michie et al., 2014) as the framework underpinning the interviews, delivery, accessibility, usability, acceptability, and adherence of the intervention will be evaluated. Transcribed audio-recordings will be analysed using thematic analysis (Braun \& Clarke, 2006). A total of 15 participants is typically sufficient to achieve data saturation (the point in data collection when no new information emerges) using this qualitative methodology (Guest et al., 2006). To allow for 18% attrition (Ferguson et al., 2016), 18 patients will be. To prevent potential confounding of the interviews, participants will not be required to complete quantitative outcome measures used in stage 2.
Stage 2. The investigators will assess which outcome measures are suitable to assess the intervention in terms how well it supported users to make changes to their behaviour. First-time hearing aid users will complete outcome measures by interview. Outcomes were selected based on the World Health Organisation's International Classification of Functioning, Disability and Health (ICF) (WHO, 2001), which provides a theoretical framework upon which to measure the success of amplification using hearing aids. At least 50 participants are required to allow for sufficient between- and within-subject variability in order to calculate important change scores for each outcome measure. To allow for 18% attrition 59 patients will be recruited.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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First-time hearing aid users
Individuals using hearing aids for the first-time (or if previous users, have not having worn hearing aids for more than 3 years) will have access to the mobile-enabled RLOs (mRLOs) intervention, which will be given to the participants shortly after their hearing aid is fitted.
Mobile-enabled RLOs (mRLOs)
A theoretically-driven, personalised educational intervention delivered through mobile technologies based on the C2Hear (https://www.youtube.com/C2HearOnline) RLOs. The mRLO intervention will include shorter 'bite-sized' RLOs suitable for mobile technologies. This will allow a unique dynamic tailoring approach, whereby relevant mRLOs will be provided based on the user's responses to a self-evaluation filter aid, which will enable individualised, tailored learning.
Interventions
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Mobile-enabled RLOs (mRLOs)
A theoretically-driven, personalised educational intervention delivered through mobile technologies based on the C2Hear (https://www.youtube.com/C2HearOnline) RLOs. The mRLO intervention will include shorter 'bite-sized' RLOs suitable for mobile technologies. This will allow a unique dynamic tailoring approach, whereby relevant mRLOs will be provided based on the user's responses to a self-evaluation filter aid, which will enable individualised, tailored learning.
Eligibility Criteria
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Inclusion Criteria
* Familiar with mobile technologies (e.g. owns a smartphone or tablet device, or uses one regularly)
* English as a first spoken language or a good understanding of English. It is important that participants can understand the content of the resources and work with the interactive elements, as well as be able to answer outcome questionnaires, to ensure valid data are collected.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Melanie A Ferguson, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute for Health Research Nottingham Biomedical Research Centre, UK
Locations
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National Institute for Health Research Nottingham Biomedical Research Centre
Nottingham, Non-US/Non-Canadian, United Kingdom
Countries
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References
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Ferguson M, Brandreth M, Brassington W, Leighton P, Wharrad H. A Randomized Controlled Trial to Evaluate the Benefits of a Multimedia Educational Program for First-Time Hearing Aid Users. Ear Hear. 2016 Mar-Apr;37(2):123-36. doi: 10.1097/AUD.0000000000000237.
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.
Michie S, Atkins L, West R. The behaviour change wheel: A guide to designing interventions. 2014;London,UK:Silverback.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101.
Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59-82.
World Health Organization, International classification of functioning, disability and health (ICF). 2001;WHO Press:Geneva,Switzerland.
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.
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.
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):P30.
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.
Wechsler, D. Wechsler Adult Intelligence Scale Third Edition. 1997;San Antonio, USA:The Psychological Corporation.
Maidment DW, Heyes R, Gomez R, Coulson NS, Wharrad H, Ferguson MA. Evaluating a Theoretically Informed and Cocreated Mobile Health Educational Intervention for First-Time Hearing Aid Users: Qualitative Interview Study. JMIR Mhealth Uhealth. 2020 Aug 5;8(8):e17193. doi: 10.2196/17193.
Other Identifiers
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213341
Identifier Type: OTHER
Identifier Source: secondary_id
17/EE/0117
Identifier Type: OTHER
Identifier Source: secondary_id
16IH003
Identifier Type: -
Identifier Source: org_study_id
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