Condition category
Ear, Nose and Throat
Date applied
13/02/2017
Date assigned
02/03/2017
Last edited
08/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Hearing-impairment affects 10 million people in the UK, 70% over the age of 70. It can lead to loneliness, isolation, social withdrawal and reduced quality-of-life. The usual treatment is to fit hearing-aids. But approximately 1 in 3 people fitted with hearing-aids find them ineffective and struggle, needing further help to gain the potential improvements reported from hearing-aid use. Although reasons for unsuccessful hearing-aid use are well documented, one solution, extra communication help, is rarely provided by NHS hearing services. Communication difficulties experienced by hearing-impaired people often lead to unsuccessful hearing-aid use if they perceive the device to be of little benefit. In two small studies the Active Communication Education programme (ACE) has been shown to improve hearing-impaired adults’ communication. The programme teaches patients and family members solutions to everyday situations where communication is difficult, such as conversing in background noise. The aim of this study is to find out whether a large study looking at the effectiveness of ACE plus a hearing aid, versus a hearing aid alone would be possible, by looking at whether people are willing and able to take part.

Who can participate?
Adults with hearing impairment who use their hearing aid for less than three hours per day.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive treatment as usual, which involves attending routine hearing-aid follow-up appointments at audiology departments. Those in the second group continue with usual treatment as well as taking part in the ACE programme with a family member. This involves attending five, two hour, weekly group sessions delivered in each department by a study audiologist. The programme teaches participants solutions to everyday situations where communication is difficult, such as conversing in background noise; communication with difficult speakers. All participants, including family members (significant others) who participate, are asked to complete a questionnaire, once at the beginning of the study and then again six months after being issued with their hearing aid(s). Those who attend the ACE are also asked to complete an additional questionnaire asking about their experience in completing the ACE programme. A smaller number of participants from both groups are interviewed to find out about their experience of taking part in the study.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. BTHFT Audiology Department, Bradford Royal Infirmary (UK)
2. YTHFT Audiology Department, York Hospital (UK)

When is the study starting and how long is it expected to run for?
February 2017 to January 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Nicholas Thyer
n.j.thyer@leeds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas Thyer

ORCID ID

http://orcid.org/0000-0002-0025-783X

Contact details

Leeds Institute of Cardiovascular and Metabolic Medicine
School of Medicine
Room 8.49
Level 8 Worsley Building
University of Leeds
Leeds
LS2 9JT
Leeds
LS2 9JT
United Kingdom
+44 1133 439713
n.j.thyer@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32595

Study information

Scientific title

Feasibility of a randomised controlled trial of the Active Communication Education (ACE) programme plus hearing-aid provision versus hearing-aid provision alone

Acronym

Study hypothesis

The aim of this study is to determine the feasibility of a future large randomised control trial investigating the effectiveness of the Active Communication Education (ACE) programme plus a hearing aid, versus a hearing aid alone in increasing hearing aid use.

Ethics approval

South East Coast - Surrey Research Ethics Committee, 16/01/2017, ref: 16/LO/2012

Study design

Randomised; Both; Design type: Treatment, Rehabilitation, Validation of investigation /therapeutic procedures

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Ear, nose and throat, Primary sub-specialty: Ear, nose and throat; UKCRC code/ Disease: Ear/ Other disorders of ear

Intervention

A remote, centralised randomisation service provided by the York Trials Unit (YTU) will allocate participants to one of two groups. Eligible, consenting patients from the same study site who have completed their baseline assessments (at the usual three months post hearing aid fitting follow up appointment), will be randomised in batches of 10-14 (intervention: control ratio of 1:1) using block randomisation in a single large block per batch. Following randomisation, a letter outlining the next steps will be sent to participants and their Significant Others (SO) where relevant).

Control group: Participants continue to receive treatment as usual (TAU). This involves three audiology department appointments:
1. Information provision and impression taken for an ear-mould
2. Hearing-aid prescription and fitting
3. Follow up

Intervention group: Participants receive the Active Communication Education (ACE) programme, which is delivered by a trained audiologist (trained using standardized ACE training manual and DVD). Over five modules, patients and their significant-others are taught and develop solutions to everyday situations where communication is difficult. These include: establishing their communication needs; listening in background noise; conversation in the home and with difficult speakers; listening to environmental sounds and; building communication confidence. Using WHO’s ICF as an underpinning framework, the programme adopts a problem solving interactive approach aimed at reducing everyday communication difficulties experienced by people with hearing-impairment and their significant-others, thereby improving quality-of-life and psychosocial well-being. The programme runs for two hours each week for five weeks, with five to seven patients (plus significant-others) per group. Participants also receive treatment as usual.

Follow-up data (self reported outcome measures) will be collected at three months and at six months post hearing-aid fitting. Follow up data regarding study feasibility and, processes will be collected during delivery of the intervention delivery and throughout the project.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Feasibility outcomes:
ACE Delivery outcomes:
1. Attendance and attrition: Attendance rates of participants and significant others at ACE sessions will be measured and who attends ACE session with the participant will be recorded
2. Fit of ACE with existing service delivery models: Attendance and attrition rates for ACE delivered at different study sites and their satellite clinics and the effect of using single and block-booking for follow-up appointments will be recorded
3. Whether ACE be delivered as intended in the ACE protocol will be assessed by recording time taken to train audiologists successfully; the number of ACE goals achieved by participants; and audiologist’s adherence to the ACE protocol (fidelity)
4. Acceptability is measured using a bespoke acceptability questionnaire/interview regarding study processes administered to participants, significant others and audiologists at final ACE session and at a comparable time for the questions for the control arm

RCT Delivery Outcomes:
1. Recruitment (during 12 month recruitment following 3 month post-hearing-aid fitting follow up appointment): Number of direct referrals; number of direct referrals struggling with their hearing-aid; number of and reasons for exclusions; number of patients who decline to participate and reason for declining; number who miss ACE intervention window (i.e. unable to attend an ACE group within 1-3 weeks after randomisation); number given an appointment for an ACE group session; and number of consented patients who fail to attend ACE
2. Allocation: Time ACE started after randomisation (ACE intervention window); time taken to recruit and logistics of recruiting an optimally sized and located ACE group
3. Outcome Measure Data: Completion and return rates of outcome measures at each time-point will be recorded as well as extent of missing data within each outcome measure (all self-reported by participants). The feasibility of collecting postal questionnaire data from these outcome measures, at each time point will be evaluated. Similarly the feasibility of collecting postal data from acceptability and resource use questionnaires at each time point will be evaluated for bespoke acceptability questionnaire regarding study processes and bespoke health care resource use questionnaire.

Secondary outcome measures

1. Hearing aid benefit is measured in control and intervention arms at 3 and 6 months post hearing aid fitting using the International Outcomes Inventory for Hearing Aids (IOI-HA)
2. ACE benefit is measured in the intervention arm only, at the end of the ACE intervention and 6 months post hearing aid fitting using the International Outcomes Inventory for Alternative Interventions (IOI-AI)
3. Communication benefit is measured in control and intervention arms at 3 and 6 months post hearing aid fitting using Self-Assessment of Communication (SAC)
4. Quality of Life is measured in control and intervention arms using the EQ-5D-5 and Short-Form 36 (SF-36) at 3 and 6 months post hearing aid fitting
5. Significant Others’ benefit from the ACE intervention is measured in the intervention arm only, using the International Outcome Inventory for Alternative Interventions: version for Significant Others (IOI-AI-SO) at the end of the ACE intervention and 6 months post hearing aid fitting
6. Hearing disability associated with significant others is measured in control and intervention arms at 3 and 6 months post hearing aid fitting using the Significant Other Scale for Hearing Disability (SOS-HEAR)

Overall trial start date

01/02/2017

Overall trial end date

31/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult Direct Access GP referral
2. Self-reported hearing-aid use less than three hours a day (supported by amount of use recorded by the hearing aid log if available; less than moderate benefit, defined by IOI-HA49 questions 1 and 2
3. Aged 18 years or over, receiving treatment-as-usual delivered in one of the two participating centres.
4. Hearing impairment: pure-tone average better ear thresholds at 500, 1000, 2000, and 4000 Hz of more than 25 dB HTL.
5. No significant self-reported history of neurological impairment
6. Willing and able to provide written informed consent
7. Able to take part in the intervention by understanding and using spoken English
8. Able to self-complete the English language outcome measure tools.

The following inclusion criteria for SOs will be assessed:
Should be a spouse or other family member who lives with or is a carer for a patient recruited to the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 112; UK Sample Size: 112

Participant exclusion criteria

1. Severe or profound bilateral hearing impairment. Pure-tone better ear average thresholds measured at 500, 1000, 2000, and 4000 Hz of more than 85 dB HTL
2. Significant on-going ear related health or mental health issues that, in the audiologist’s or associate audiologist’s professional opinion would preclude hearing-aid fitting or attendance at ACE sessions
3. Unable or unwilling to give written informed consent

Recruitment start date

01/03/2017

Recruitment end date

28/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

BTHFT Audiology Department, Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

YTHFT Audiology Department, York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom

Sponsor information

Organisation

Bradford Teaching Hospitals NHS Foundation Trust

Sponsor details

The Research Management & Support Office
Bradford Institute for Health Research
Bradford Royal Infirmary
Duckworth Lane
Bradford BD9 6RJ
Bradford
BD9 6RJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal with an intent to publish date of December 2019.

IPD Sharing plan:
The datasets generated and/or analysed during the during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes