mHealth Technologies for Hearing Aid Users

NCT03136718 | Completed

• 3 other identifiers: 16IH00321334117/EE/0117
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss

Keywords

mHealth; Hearing aids; Auditory rehabilitation; Adult; Reusable Learning Object; Education; Personalised; Telehealth; Teleaudiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Hearing aid datalogging

  Following 10-12 weeks of independent use of the mRLO intervention

• Glasgow Hearing Aid Benefit Profile (GHABP)

  Baseline (Part I) and following 10-12 weeks of independent use of the mRLO intervention (Part II)

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

  Baseline and following 10-12 weeks of independent use of the mRLO intervention

• Social Participation Restrictions Questionnaire (SPaRQ: Heffernan et al., 2015)

  Baseline and following 10-12 weeks of independent use of the mRLO intervention

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

  Baseline and following 10-12 weeks of independent use of the mRLO intervention

Other Outcomes (1)

• Adverse effects

  12 weeks

Study Arms (1)

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.

Other: Mobile-enabled RLOs (mRLOs)

Interventions

Mobile-enabled RLOs (mRLOs) OTHER

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.

First-time hearing aid users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

First-time hearing aid users will be recruited from Nottingham Audiology Services, Nottingham University Hospitals NHS Trust, UK (secondary care). Interested patients will be invited to participate within 2 weeks of receiving their hearing aid, ideally as soon as possible. Participants will be recruited using maximum variation sampling.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• University of Nottingham: collaborator

Study Sites (1)

National Institute for Health Research Nottingham Biomedical Research Centre

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

Location

Related Publications (12)

• 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.

  PMID: 26565785 BACKGROUND

• 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.

  PMID: 26649541 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 7095321 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18049965 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 32755885 DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melanie A Ferguson, PhD

  National Institute for Health Research Nottingham Biomedical Research Centre, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: May 2, 2017
• Study Start: April 1, 2017
• Primary Completion: August 9, 2018
• Study Completion: October 24, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)