Feasibility of an Online Rehabilitation Program

October 10, 2018 updated by: University of Nottingham

Assessing the Feasibility of a Clinical Trial of an Online Audiological Rehabilitation Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Non-US/Non-Canadian
      • Nottingham, Non-US/Non-Canadian, United Kingdom, NG1 5DU
        • National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Eriksholm Guide to Better Hearing
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
Online rehabilitation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Handicap Inventory for the Elderly (HHIE: Ventry & Weinstein, 1982)
Time Frame: Change from Baseline following up to 5 weeks of independent use of the online intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Outcome Inventory for Hearing Aids (IOI-HA: Cox & Alexander, 2002)
Time Frame: Baseline and following up to 5 weeks of independent use of the online intervention
A seven-item questionnaire (use, benefit, residual activity limitation, satisfaction, residual participation restriction, importance to others, quality of life) and is scored on a five-point scale.
Baseline and following up to 5 weeks of independent use of the online intervention
Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999)
Time Frame: Baseline (Part 1 only) and following up to 5 weeks of independent use of the online intervention (Part 2 only)
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 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)
Time Frame: Baseline and following up to 5 weeks of independent use of the online intervention
A 19-item inventory that assesses social behaviours (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 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)
Time Frame: Baseline and following up to 5 weeks of independent use of the online 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).
Baseline and following up to 5 weeks of independent use of the online intervention
Practical Hearing Aid Skills Test (PHAST: Desjardins & Doherty, 2009)
Time Frame: Baseline and following up to 5 weeks of independent use of the online intervention
Tests eight hearing aid skills (insertion, removal, opening battery door, changing the battery, cleaning the aid, manipulating the voice clarity (VC), telephone use, and use of programs). Each skill was scored on a five-point Likert scale (0=cannot perform, 4=excellent).
Baseline and following up to 5 weeks of independent use of the online intervention
Hearing Aid and Communication Knowledge (HACK: Ferguson et al, 2015)
Time Frame: Baseline and following up to 5 weeks of independent use of the online 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.
Baseline and following up to 5 weeks of independent use of the online intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Eriksholm Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

March 21, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGS 16086
  • IRAS Project id: 214225 (Other Identifier: National Health Service Health Research Authority)
  • 16IH008 (Other Identifier: Nottingham University Hospitals NHS Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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