mHealth Technologies for Hearing Aid Users (m2Hear)

March 6, 2019 updated by: Nottingham University Hospitals NHS Trust

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

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 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999) - Hearing aid use
Time Frame: Following 10-12 weeks of independent use of the mRLO intervention
Self-reported hearing aid use measured on a five-point scale.
Following 10-12 weeks of independent use of the mRLO intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hearing aid datalogging
Time Frame: Following 10-12 weeks of independent use of the mRLO intervention
Hearing aid use in hours internal to the hearing aid
Following 10-12 weeks of independent use of the mRLO intervention
Glasgow Hearing Aid Benefit Profile (GHABP)
Time Frame: Baseline (Part I) and following 10-12 weeks of independent use of the mRLO intervention (Part II)
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)
Hearing Handicap Inventory for the Elderly (HHIE: Ventry & Weinstein, 1982)
Time Frame: Baseline and following 10-12 weeks of independent use of the mRLO intervention
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
Social Participation Restrictions Questionnaire (SPaRQ: Heffernan et al., 2015)
Time Frame: Baseline and following 10-12 weeks of independent use of the mRLO intervention
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
Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (MARS-HA: West & Smith, 2007)
Time Frame: Baseline and following 10-12 weeks of independent use of the mRLO 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 10-12 weeks of independent use of the mRLO intervention
Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015)
Time Frame: Baseline and following 10-12 weeks of independent use of the mRLO 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 10-12 weeks of independent use of the mRLO intervention
Clinical Global Impression Scale - Hearing difficulties
Time Frame: Baseline and following 10-12 weeks of independent use of the mRLO intervention
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
Wechsler Adult Intelligence Scale (WAIS) - Digit Span (Wechsler, 1997)
Time Frame: Baseline and following 10-12 weeks of independent use of the mRLO intervention
Cognitive measure of memory recall
Baseline and following 10-12 weeks of independent use of the mRLO intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 12 weeks
Adverse effects arising from the intervention
12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nottingham University Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Nottingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melanie A Ferguson, PhD, National Institute for Health Research Nottingham Biomedical Research Centre, UK

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16IH003
  • 213341 (OTHER: IRAS ID)
  • 17/EE/0117 (OTHER: REC)

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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