mHealth Technologies for Hearing Aid Users

Hearing Loss Clinical Trial

— m2Hear  

Official title:

The Feasibility of mHealth Technologies to Improve Hearing Aid Use and Benefit in First-time Hearing Aid Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136718
• Other study ID #: 16IH003
• Secondary ID: 21334117/EE/0117
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: October 24, 2018

Study information

• Verified date: March 2019
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: October 24, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First-time hearing aid users (or if previous users, but not having worn hearing aids for more than 3 years)

• 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:

• Unable to complete the questionnaires without assistance due to age-related problems (e.g. cognitive decline or dementia), to ensure valid data are collected.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	National Institute for Health Research Nottingham Biomedical Research Centre	Nottingham	Non-US/Non-Canadian

Sponsors (2)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101.

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. — View Citation

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. — View Citation

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.

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.

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.

Michie S, Atkins L, West R. The behaviour change wheel: A guide to designing interventions. 2014;London,UK:Silverback.

Ventry IM, Weinstein BE. The hearing handicap inventory for the elderly: a new tool. Ear Hear. 1982 May-Jun;3(3):128-34. — View Citation

Wechsler, D. Wechsler Adult Intelligence Scale Third Edition. 1997;San Antonio, USA:The Psychological Corporation.

West RL, Smith SL. Development of a hearing aid self-efficacy questionnaire. Int J Audiol. 2007 Dec;46(12):759-71. — View Citation

World Health Organization, International classification of functioning, disability and health (ICF). 2001;WHO Press:Geneva,Switzerland.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects	Adverse effects arising from the intervention	12 weeks
Primary	Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999) - Hearing aid use	Self-reported hearing aid use measured on a five-point scale.	Following 10-12 weeks of independent use of the mRLO intervention
Secondary	Hearing aid datalogging	Hearing aid use in hours internal to the hearing aid	Following 10-12 weeks of independent use of the mRLO intervention
Secondary	Glasgow Hearing Aid Benefit Profile (GHABP)	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.	Baseline (Part I) and following 10-12 weeks of independent use of the mRLO intervention (Part II)
Secondary	Hearing Handicap Inventory for the Elderly (HHIE: Ventry & Weinstein, 1982)	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).	Baseline and following 10-12 weeks of independent use of the mRLO intervention
Secondary	Social Participation Restrictions Questionnaire (SPaRQ: Heffernan et al., 2015)	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.	Baseline and following 10-12 weeks of independent use of the mRLO intervention
Secondary	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).	Baseline and following 10-12 weeks of independent use of the mRLO intervention
Secondary	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.	Baseline and following 10-12 weeks of independent use of the mRLO intervention
Secondary	Clinical Global Impression Scale - Hearing difficulties	A one item questionnaire to be used to identify the minimal important change score specific to each self-reported outcome measure.	Baseline and following 10-12 weeks of independent use of the mRLO intervention
Secondary	Wechsler Adult Intelligence Scale (WAIS) - Digit Span (Wechsler, 1997)	Cognitive measure of memory recall	Baseline and following 10-12 weeks of independent use of the mRLO intervention