Clinical trial NCT03408535: Feasibility of an Online Rehabilitation Program
Official title: Assessing the Feasibility of a Clinical Trial of an Online Audiological Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: eHealth
Online Rehabilitation
Hearing Problems
Adult
Hearing Aids
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Eriksholm Research Centre
First posted: 2018-01-24
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: STUDY PURPOSE

This feasibility study is a precursor of a randomised controlled trial (RCT) that will evaluate the effectiveness of an English-speaking version of the online program originally evaluated by Thorén et al in adult hearing aid users. This study will estimate a number of parameters necessary for the robust design of an RCT. This systematic approach of completing a feasibility study prior to a full-scale evaluation is strongly advocated by the Medical Research Council (MRC) guidelines for developing and evaluating complex interventions, ensuring that any uncertainties are addressed and that the intervention operates as intended.

OBJECTIVES

This study will be used to estimate the following parameters:

(I) Recruitment

1. Willingness of clinicians to recruit participants
2. Willingness of participants to consent
3. Number of eligible patients.

(II) Feasibility/acceptability of approach (Quantitative outcomes)

1. Characteristics of the outcome measures
2. Standard deviation of outcome measures to estimate sample size
3. Follow-up rates, response rates to questionnaires, adherence/compliance rates
4. Time needed to collect and analyse data.

(III) Users' perspective/opinions of the intervention (Qualitative outcomes)

1. Participant's views regarding delivery of the program through different devices
2. How the program is used and how often (i.e. usability)
3. Participants views concerning what they like and dislike about the program (i.e.

   acceptability)
4. How much of the program is completed (adherence).

STUDY CONFIGURATION

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.

Primary endpoint. In accordance with objective (II) feasibility/acceptability of approach, follow-up measures will be recorded upon completion of the last intervention module

Secondary endpoint. In accordance with objective (III) users' perspective/opinions of the intervention, completion of focus groups.

Participant Duration. Participants will take part in an initial assessment, which is estimated to last 1.5 hours. After completing the weekly online modules from home, participants will then take part in a follow-up assessment which will last up to 1.5 hours. A sub-sample of 16 participants will also be invited to take part focus groups lasting 1.5 hours (end of the study).

Recruitment. Existing hearing aid users will be identified from the National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC) Otology and Hearing Group's participant database. Participants in this database have provided consent to be approached about future research studies.

First-time hearing aid users will be recruited from publically funded National Health Service (NHS) Adult Audiology Departments in the East Midlands, UK.

All participants who express an interest in the study will receive a participant information sheet, alongside a pre-paid, addressed envelope in which to return their response if they choose to take part.

STATISTICS

Methods. The study data will be analysed by the research team at the NIHR Nottingham BRC. All data will be analysed on University of Nottingham computers and backed up to the University of Nottingham servers. Data will be analysed using STATA version 14. Continuous data will be summarised using means and standard deviations, whereas categorical data will be summarised using percentages. For each measure, the difference between baseline and follow-up will be examined using a paired samples t-test or Wilcoxon signed rank test. Medians and quartiles will be reported for non-parametric data, and means, standard deviations and 95% confidence intervals for parametric data. Statistical significance will be set at p=.05. As outcome data will be collected after the intervention period, no interim analyses will be performed.

Sample size and justification. The sample size estimate is based on the difference between two dependent means; baseline and follow-up. An a priori sample size calculation (G\*power v.3.0.10) based on a medium effect size (Cohen's d=0.5), a one-sided Type I error rate of 5%, and 80% power, revealed that a sample size of 27 participants will be required for each sample (first-time and existing hearing aid users).

Assessment of efficacy. This is a feasibility study of a clinical study and, as such, will not assess the efficacy of the online rehabilitation program.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. Used hearing aids for at least one year (existing hearing aid users), or
  2. 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hearing Handicap Inventory for the Elderly (HHIE: Ventry & Weinstein, 1982)
timeFrame: Change from Baseline following up to 5 weeks of independent use of the online intervention
Secondary outcomes:
measure: International Outcome Inventory for Hearing Aids (IOI-HA: Cox & Alexander, 2002)
timeFrame: Baseline and following up to 5 weeks of independent use of the online intervention
measure: Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999)
timeFrame: Baseline (Part 1 only) and following up to 5 weeks of independent use of the online intervention (Part 2 only)
measure: Social Participation Restrictions Questionnaire (SPaRQ: Heffernan et al., 2016)
timeFrame: Baseline and following up to 5 weeks of independent use of the online intervention
measure: Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (MARS-HA: West & Smith, 2007)
timeFrame: Baseline and following up to 5 weeks of independent use of the online intervention
measure: Practical Hearing Aid Skills Test (PHAST: Desjardins & Doherty, 2009)
timeFrame: Baseline and following up to 5 weeks of independent use of the online intervention
measure: Hearing Aid and Communication Knowledge (HACK: Ferguson et al, 2015)
timeFrame: Baseline and following up to 5 weeks of independent use of the online intervention
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre
state: Non-US/Non-Canadian
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.1044/2015_AJA-14-0088.
citation: Medical Research Council. Developing and evaluating complex interventions: new guidance. 2006. Retrieved from: https://www.mrc.ac.uk/documents/pdf/complex-interventions-guidance/.