National Institute for Health Research Nottingham Biomedical Research Centre
Nottingham, Non-US/Non-Canadian, NG1 5DU, United Kingdom
NCT Number: NCT03136718
This study will establish the feasibility of a theoretically-driven, personalised educational intervention delivered through mobile technologies in first-time hearing aid users. Namely, the C2Hear (https://www.youtube.com/C2HearOnline) multimedia videos, or Reusable Learning Objects (RLOs) (Ferguson et al., 2015; 2016), will be repurposed into short 'bite-sized' mobile-enabled RLOs (mRLOs).The development of the intervention will be based on a recently developed comprehensive model of health behaviour change (COM-B) (Michie et al., 2014). The intervention will be tailored to individuals' needs, and incorporate greater user interactivity and self-evaluation.
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Notify Me18 year and older
All sexes
Observational
Nottingham, Non-US/Non-Canadian, NG1 5DU, United Kingdom
Research question: Is it feasible for first-time hearing aid users to use a personalised educational intervention delivered through mobile technologies in their everyday life?
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Following 10-12 weeks of independent use of the mRLO intervention
Self-reported hearing aid use measured on a five-point scale.
Time frame: Following 10-12 weeks of independent use of the mRLO intervention
Hearing aid use in hours internal to the hearing aid
Time frame: Baseline (Part I) and following 10-12 weeks of independent use of the mRLO intervention (Part II)
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 and following 10-12 weeks of independent use of the mRLO intervention
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: Baseline and following 10-12 weeks of independent use of the mRLO intervention
A 19-item inventory that assesses social behaviors (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 10-12 weeks of independent use of the mRLO intervention
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 10-12 weeks of independent use of the mRLO intervention
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 10-12 weeks of independent use of the mRLO intervention
A one item questionnaire to be used to identify the minimal important change score specific to each self-reported outcome measure.
Time frame: Baseline and following 10-12 weeks of independent use of the mRLO intervention
Cognitive measure of memory recall
Time frame: 12 weeks
Adverse effects arising from the intervention
Nottingham University Hospitals NHS Trust
Other
The Feasibility of mHealth Technologies to Improve Hearing Aid Use and Benefit in First-time Hearing Aid Users
Acronym: m2Hear
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