Feasibility of an Online Rehabilitation Program

NCT03408535 | Completed

• 3 other identifiers: RGS 16086IRAS Project id: 21422516IH008
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss

Keywords

eHealth; Online Rehabilitation; Hearing Problems; Adult; Hearing Aids

Outcome Measures

Primary Outcomes (1)

• 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).

  Change from Baseline following up to 5 weeks of independent use of the online intervention

Secondary Outcomes (6)

• International Outcome Inventory for Hearing Aids (IOI-HA: Cox & Alexander, 2002)

  Baseline and following up to 5 weeks of independent use of the online intervention

• Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999)

  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)

  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)

  Baseline and following up to 5 weeks of independent use of the online intervention

• Practical Hearing Aid Skills Test (PHAST: Desjardins & Doherty, 2009)

  Baseline and following up to 5 weeks of independent use of the online intervention

Study Arms (1)

Eriksholm Guide to Better Hearing

OTHER

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

Interventions

Eriksholm Guide to Better Hearing OTHER

Online rehabilitation program.

Eriksholm Guide to Better Hearing

Eligibility Criteria

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

You may qualify if:

• Ability to give informed consent
• English as first spoken language or good understanding of English.
• Adults aged ≥18 years (no upper age limit)
• Mild-to-moderate hearing loss (average hearing threshold across octave frequencies 0.25-4kHz ≥20 and ≤70dB HL)
• Have either:
• Used hearing aids for at least one year (existing hearing aid users), or
• Have not used hearing aids or an alternative form of amplification (e.g. personal sound amplification products) within the past two years (first-time hearing aid users)
• Access the Internet and compatible device (e.g. computer or tablet device).

You may not qualify if:

• Report having severe tinnitus
• Diagnosis of Ménière's disease
• Patients who are unable to complete the questionnaires without assistance due to age- related problems such as cognitive decline and dementia.

Sponsors & Collaborators

• University of Nottingham: lead
• Eriksholm Research Centre: collaborator

Study Sites (1)

National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre

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

Location

Related Publications (10)

• Thoren ES, Oberg M, Wanstrom G, Andersson G, Lunner T. A randomized controlled trial evaluating the effects of online rehabilitative intervention for adult hearing-aid users. Int J Audiol. 2014 Jul;53(7):452-61. doi: 10.3109/14992027.2014.892643. Epub 2014 Apr 22.

  PMID: 24749664 BACKGROUND

• Thoren E, Svensson M, Tornqvist A, Andersson G, Carlbring P, Lunner T. Rehabilitative online education versus internet discussion group for hearing aid users: a randomized controlled trial. J Am Acad Audiol. 2011 May;22(5):274-85. doi: 10.3766/jaaa.22.5.4.

  PMID: 21756843 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

• Cox RM, Alexander GC. The International Outcome Inventory for Hearing Aids (IOI-HA): psychometric properties of the English version. Int J Audiol. 2002 Jan;41(1):30-5. doi: 10.3109/14992020209101309.

  PMID: 12467367 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

• 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):30.

  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

• Desjardins JL, Doherty KA. Do experienced hearing aid users know how to use their hearing AIDS correctly? Am J Audiol. 2009 Jun;18(1):69-76. doi: 10.1044/1059-0889(2009/08-0022). Epub 2009 Apr 20.

  PMID: 19380509 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

• Medical Research Council. Developing and evaluating complex interventions: new guidance. 2006. Retrieved from: https://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/.

  BACKGROUND

MeSH Terms

Conditions

Hearing Loss; Hearing Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 24, 2018
• Study Start: November 1, 2016
• Primary Completion: March 21, 2018
• Study Completion: April 30, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)