Assessing memory in older adults in hearing aid appointments
| ISRCTN | ISRCTN12354959 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12354959 |
| IRAS number | 302975 |
| Secondary identifying numbers | CPMS 52139, IRAS 302975 |
- Submission date
- 09/06/2022
- Registration date
- 06/07/2022
- Last edited
- 14/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Both hearing loss and dementia are common in older people and recent research has shown that hearing impairment may increase the risk of developing dementia. However, it is currently uncommon in NHS hearing aid clinics to assess for memory problems. We know that getting help early for such problems is important in improving and maintaining the quality of life. A short memory assessment with older people attending these clinics could allow us to discover any relevant concerns. Knowing this may help with both hearing aid appointments and for prompting early appropriate help beyond these.
The proposed study will examine whether introducing a brief memory assessment in older adults attending the Royal National ENT and Eastman Dental Hospital’s hearing aid clinics is achievable and acceptable to patients. The assessment will screen for potential memory problems, it is not intended as a full-scale memory assessment. We will observe how it can be organised, how long it takes, what both patient and audiologist experience is, note how the results affect any follow on appointments in the clinic, and, if relevant, monitor what further steps are taken. We are also exploring the views of patients, their carers/family members, and of clinicians involved in the care of patients with hearing loss on the use of memory assessments in audiology appointments.
Who can participate?
Patients aged 65 and over presenting to University College London Hospitals Royal National Ear Nose and Throat Hospitals hearing aid clinics
What does the study involve?
Patients attending their hearing aid clinic appointment will be greeted by both a clinical audiologist and a research audiologist. The research audiologist will take informed consent from the patient to participate in the study, and observe and take notes on how the appointment runs. The clinical audiologist will then proceed with the standard appointment procedures, which include taking a history of the participant's hearing and general health and examining the participant's ears with an otoscope, followed by the additional short memory assessment. The memory assessment will be done through a visual presentation on an iPad, guided by the clinical audiologist. The participant or their accompanying person will then be asked to complete a questionnaire about the participant's memory. The clinical audiologist will discuss the results of the memory assessment and, with the participant's agreement, inform the GP in the clinic letter. The memory assessment and discussion of results are expected to take 15 minutes. The appointment will then carry on as per usual i.e. the audiologist will test the patient's hearing, discuss the results and make recommendations on hearing care, including the fitting of hearing aids.
The research audiologist will arrange a telephone/video follow-up appointment 3 months later to ask about further steps taken following the memory assessment, e.g. whether the participant has contacted their GP and what was decided by the GP. The participant will also be asked if they would like to take part in a separate interview to discuss their experience of the study. This is optional and will not affect participation in the main study.
What are the possible benefits and risks of participating?
By taking part in this study, the patient and their GP will have some initial information about their memory. This may allow the GP to be informed at an earlier time than the standard pathway and the patient and GP can decide together whether to seek specialist assessment. This research may also improve hearing care for older people.
The brief memory assessment may cause worry and distress for the patient. This will be addressed as best as possible by providing clear information of what is to be expected from the study, that this is not a full memory assessment and sometimes the result indicates a potential problem but a full assessment may show their memory is fine, and the opposite may be true as well. The patient will have the opportunity to stop the memory tests at any time or withdraw from the study. The patient will also have the opportunity to speak with the chief investigator should they have any worries or concerns.
Where is the study run from?
University College London Hospitals (UK)
When is the study starting and how long is it expected to run for?
October 2021 to March 2024
Who is funding the study?
1. University College London Hospitals (UK)
2. Sonova Hearing Care Solutions (Switzerland)
Who is the main contact?
Dr Rohani Omar
uclh.study302975@nhs.net
Contact information
Public, Scientific, Principal Investigator
Royal National ENT and Eastman Dental Division
University College London Hospitals
3rd Floor 179a Tottenham Court Road
London
W1T 7PA
United Kingdom
 ORCID ID |
0000-0002-5711-6843 |
|---|---|
| Phone | +44(0)20 3446 7890 |
| uclh.study302975@nhs.net |
Study information
| Study design | Single-centre pilot feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Pilot feasibility study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Pilot study on feasibility of cognitive assessment in Royal National ENT and Eastman Dental Hospital UCLH Trust (RNENTH) hearing aid clinics |
| Study objectives | This study aims to examine the feasibility and impact of cognitive assessments in RNENTH hearing aid clinics. If the study shows that cognitive assessment is acceptable to patients, their accompanying person(s) and hearing clinicians, feasible within the setting of these clinics and adds value to patient care, it may allow wider implementation across NHS/private hearing aid clinics. |
| Ethics approval(s) | Approved 03/05/2022, London - Riverside Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 (0)207 104 8184; riverside.rec@hra.nhs.uk), ref 22/LO/0180 |
| Health condition(s) or problem(s) studied | Hearing loss |
| Intervention | 20 participants aged 65 and over will be recruited through the Hearing Aid Clinics at the Royal National ENT Hospital, Finchley Memorial Hospital and/or Edgware Community Hospital. Prior to starting cognitive assessments, the Clinical Audiologists will undergo required training on performing the assessments, discussion and notification of their GP of results. Candidates will be sent a letter and patient information sheet explaining more about the study. These invites will be sent three weeks prior to attending their hearing aid clinic appointment so that they have time to consider participation. After check-in by the RNENTH administrative team, the research audiologist will take the patient and accompanying person (if present) to a separate room, verify if they have received and read the information, explore their interest in the study and check inclusion and exclusion criteria. To those patients interested in taking part, they will explain the study and procedures, answer questions and take informed consent. To those consenting, the clinical audiologist will conduct a short cognitive screening test adapted for hearing-impaired patients and a dementia screening questionnaire. If scores are low and/or patients express concern about results, the audiologist will advise that they contact their GP and ask permission from the patient to send the results to their GP, who can decide if further assessment is needed such as referral to a memory service. The cognitive assessment and discussion of results should take around 15 minutes. Practicalities and timings of cognitive assessment including discussion of results will be observed by the research audiologist and recorded on a Case Report Form (CRF), along with completion of the assessment and the results. Three months after the clinic visit the patient and/or accompanying person will be contacted by telephone/video call by a study team member to establish impact of testing i.e. whether they contacted their GP, whether referral to memory service was made, and the outcome of this referral. Patients, accompanying persons and clinicians (two of each) will also be invited to take part in a qualitative study, sharing their experiences of participating in or running the study through a semi-structured interview. This qualitative study will also include interviews with the referring clinicians of the participants including ENT surgeons, Audiovestibular physicians and GPs (two of each). They will be recruited from the pool of professionals already involved in the care of the patient participants. These professionals will only be approached after the patient has consented to the study. Informed consent will be obtained from these individuals to have their answers transcribed for the study. |
| Intervention type | Other |
| Primary outcome measure | Proportion of cognitive assessments completed measured as the percentage of patients completing the cognitive assessment out of the total number approached for the study at their initial Royal National Ear Nose and Throat Hospital hearing aid clinic appointment (baseline) |
| Secondary outcome measures | 1. Impact, defined as follow-on actions regarding onward care of cognitive impairment, assessed at a 3-month remote follow-up appointment 2. Practicality, defined as the amount of training required for staff to perform cognitive assessments (assessed by the research team at the training session for clinical audiologists, prior to baseline visit), and staff and space allocation and duration of cognitive assessments (assessed by the research team at the initial Royal National Ear Nose and Throat Hospital hearing aid clinic appointment; baseline visit) 3. Acceptability, defined as the experience of the patient, accompanying person, and hearing clinician, including reasons for agreeing to the assessment, views on the assessment process, outcome and follow-on actions, and impact on the operation of hearing aid clinics, explored through semi-structured qualitative interviews, after completion of the 3-month remote follow-ups |
| Overall study start date | 13/10/2021 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Patients aged 65 years and older 2. Patients attending Royal National Ear Nose and Throat Hospital hearing aid clinics |
| Key exclusion criteria | Patients who lack the capacity to consent |
| Date of first enrolment | 30/06/2022 |
| Date of final enrolment | 31/01/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
WC1E 6DG
United Kingdom
Sponsor information
Hospital/treatment centre
UCLH/UCL Joint Research Office, part of Research Directorate
4th Floor West
250 Euston Road
London
NW12PG
England
United Kingdom
| Phone | +44 (0)20 3447 9928 |
|---|---|
| uclh.randd@nhs.net | |
| Website | https://www.ucl.ac.uk/jro |
"ROR" |
https://ror.org/042fqyp44 |
Funders
Funder type
Industry
No information available
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University College London Hospitals, UCLH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | We will present the findings of our project at local and inter(national) stakeholders conferences and publish in the scientific literature for the attention of professional and scientific audiences. A lay summary report will also be published for patients and members of the public who will be reached via our PPI representatives, stakeholder organisations’ websites, social media channels and email updates. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/02/2024: The study's public and scientific contacts were changed.
05/07/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2023 to 31/01/2024.
2. The overall trial end date was changed from 30/06/2023 to 31/03/2024.
04/01/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2023 to 31/03/2023.
2. The overall trial end date was changed from 31/05/2023 to 30/06/2023.
3. The intention to publish date was changed from 31/01/2024 to 31/03/2024.
15/06/2022: Trial's existence confirmed by HRA.
