Hearing Lossm2HearNCT03136718
mHealth Technologies for Hearing Aid Users
An observational study of Hearing Loss, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Mobile-enabled RLOs (mRLOs)
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2017to 24 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Unable to complete the questionnaires without assistance due to age-related problems (e.g. cognitive decline or dementia), to ensure valid data are collected.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Institute for Health Research Nottingham Biomedical Research Centre
Nottingham, Non-US/Non-Canadian, NG1 5DU
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Mobile-enabled RLOs (mRLOs)
- Keywords
- mHealth, Hearing aids, Auditory rehabilitation, Adult, Reusable Learning Object, Education, Personalised, Telehealth, Teleaudiology
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mobile-enabled RLOs (mRLOs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999) - Hearing aid use
Self-reported hearing aid use measured on a five-point scale.
Measured: Following 10-12 weeks of independent use of the mRLO intervention
Secondary outcomes (8)
Hearing aid datalogging
Hearing aid use in hours internal to the hearing aid
Measured: Following 10-12 weeks of independent use of the mRLO intervention
Glasgow Hearing Aid Benefit Profile (GHABP)
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.
Measured: 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)
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).
Measured: Baseline and following 10-12 weeks of independent use of the mRLO intervention
Social Participation Restrictions Questionnaire (SPaRQ: Heffernan et al., 2015)
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.
Measured: 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)
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).
Measured: Baseline and following 10-12 weeks of independent use of the mRLO intervention
Hearing Aid and Communication Knowledge (HACK: Ferguson et al., 2015)
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.
Measured: Baseline and following 10-12 weeks of independent use of the mRLO intervention
Clinical Global Impression Scale - Hearing difficulties
A one item questionnaire to be used to identify the minimal important change score specific to each self-reported outcome measure.
Measured: Baseline and following 10-12 weeks of independent use of the mRLO intervention
Wechsler Adult Intelligence Scale (WAIS) - Digit Span (Wechsler, 1997)
Cognitive measure of memory recall
Measured: Baseline and following 10-12 weeks of independent use of the mRLO intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Apr 2017
- Primary completion9 Aug 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Melanie A Ferguson, PhD, Principal investigator, National Institute for Health Research Nottingham Biomedical Research Centre, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136718
- Sponsor's protocol ID
- 16IH003
- Other IDs
- 213341, 17/EE/0117
- Acronym
- m2Hear
- Status last verified
- Mar 2019
- First submitted
- 13 Apr 2017
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26565785Ferguson 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.
PubMed 26649541Michie S, Atkins L, West R. The behaviour change wheel: A guide to designing interventions. 2014;London,UK:Silverback.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101.
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.
World Health Organization, International classification of functioning, disability and health (ICF). 2001;WHO Press:Geneva,Switzerland.
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.
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.
PubMed 7095321Heffernan 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.
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.
PubMed 18049965Wechsler, D. Wechsler Adult Intelligence Scale Third Edition. 1997;San Antonio, USA:The Psychological Corporation.
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.
PubMed 32755885
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of mHealth Technologies to Improve Hearing Aid Use and Benefit in First-time Hearing Aid Users
- ClinicalTrials.gov ID
- NCT03136718
- Acronym / sponsor ID
- m2Hear / 16IH003
- Conditions
- Hearing Loss
- Keywords
- mHealth, Hearing aids, Auditory rehabilitation, Adult, Reusable Learning Object, Education, Personalised, Telehealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-time hearing aid users | – | Other: Mobile-enabled RLOs (mRLOs)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Unable to complete the questionnaires without assistance due to age-related problems (e.g. cognitive decline or dementia), to ensure valid data are collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | First-time hearing aid users |
Primary outcome
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.
8 secondary outcomes
Hearing aid datalogging
Time frame: 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)
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
Social Participation Restrictions Questionnaire (SPaRQ: Heffernan et al., 2015)
Time frame: 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
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
Clinical Global Impression Scale - Hearing difficulties
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Background: PubMed 26565785Ferguson 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.
- Background: PubMed 26649541Ferguson 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.
- BackgroundMichie S, Atkins L, West R. The behaviour change wheel: A guide to designing interventions. 2014;London,UK:Silverback.
- BackgroundBraun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101.
- BackgroundGuest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59-82.
- BackgroundWorld Health Organization, International classification of functioning, disability and health (ICF). 2001;WHO Press:Geneva,Switzerland.
- BackgroundGatehouse 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: PubMed 7095321Ventry 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.
- BackgroundHeffernan 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: PubMed 18049965West RL, Smith SL. Development of a hearing aid self-efficacy questionnaire. Int J Audiol. 2007 Dec;46(12):759-71. doi: 10.1080/14992020701545898.
- BackgroundWechsler, D. Wechsler Adult Intelligence Scale Third Edition. 1997;San Antonio, USA:The Psychological Corporation.
- Derived from this study: PubMed 32755885Maidment 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie A Ferguson, PhD principal investigator
National Institute for Health Research Nottingham Biomedical Research Centre, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Hearing Aid Benefit Profile (GHABP: Gatehouse, 1999) - Hearing aid use (time frame: Following 10-12 weeks of independent use of the mRLO intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136718, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.