Condition category
Nervous System Diseases
Date applied
17/02/2020
Date assigned
20/02/2020
Last edited
19/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
It is a new finding that hearing loss is major risk factor for subsequent dementia. Hearing loss increases dementia risk more than lacking education, being diabetic or depressed or having a poor diet. Therefore, untreated hearing loss may be a missed opportunity to delay and prevent dementia in a substantial number of people. The researchers want to find out if a hearing aid intervention can prevent or delay the onset of dementia in older adults who are at greater risk of developing dementia (i.e. those with mild cognitive impairment). Before the researchers can do a full trial to answer this question, the researchers need to run a pilot trial to see if the researchers can recruit participants and assess the acceptability of the proposed interventions.

The researchers plan to compare two interventions in this pilot trial. The hearing intervention will involve hearing aid provision and support over four sessions, while the healthy ageing intervention will involve standard audiological care (i.e. the participant will be informed of their hearing loss and advised to see their GP) and four one-to-one sessions with a researcher on behavioural changes that can promote healthy ageing and may reduce risk of progression from mild cognitive impairment to dementia.

Who can participate?
Persons living in the community, 55 years of age or older with mild cognitive impairment and hearing loss.

What does the study involve?
Participants will be randomly allocated to receive either a hearing aid plus support or home based sessions on behavioural changes. Each eligible participant will receive seven visits over six months, including the four intervention sessions. At two of the visits (baseline and follow up) they will be asked to complete some cognitive and mood assessments.

What are the possible benefits and risks of participating?
Benefits: Participants could potentially benefit from a hearing test and appropriate treatment. Also, the information the researchers get might lead to a larger trial which might help to improve things for people with mild cognitive impairment in the future.
Risks: The researchers do not feel there are any risks associated with this trial. There is a small chance that participants who are asked to wear a hearing aid might experience dizziness, nervousness or headaches or local discomfort. The researchers ask participants about any problems they are experiencing with the hearing aid and the research audiologist will try to correct these. Some of the questionnaires ask sensitive questions. If participants become upset or distressed by any of these questions, they do not have to answer them and ask to move on.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
October 2018 to February 2021

Who is funding the study?
Alzheimer’s Research UK

Who is the main contact?
Dr Sergi Costafreda Gonzalez (scientific)
s.costafreda@ucl.ac.uk
Kingsley Powell (public)
kingsley.powell@ucl.ac.uk

Trial website

http://www.ucl.ac.uk/psychiatry/tact-trial

Contact information

Type

Scientific

Primary contact

Dr Sergi Costafreda Gonzalez

ORCID ID

http://orcid.org/0000-0002-8910-3430

Contact details

Mental Health of Older Adults
Division of Psychiatry
UCL
6th Floor
Wing A
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 (0)2076799059
s.costafreda@ucl.ac.uk

Type

Public

Additional contact

Miss Kingsley Powell

ORCID ID

Contact details

Division of Psychiatry
UCL
6th Floor
Wing A
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 (0)2031086274
kingsley.powell@ucl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

18/0079, IRAS 246188

Study information

Scientific title

Treating Auditory impairment and CogniTion: a randomised, parallel, pilot trial in older adults with mild cognitive impairment and hearing loss of an intervention to provide and support hearing aid use vs a health education intervention for dementia risk.

Acronym

TACT

Study hypothesis

The aim of the study is to establish feasibility of recruitment, randomisation, retention, acceptability of the study interventions (Hearing Intervention and Healthy Ageing Intervention).

Ethics approval

Approved 24/08/2018, London - Surrey Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)207 104 8222; NRESCommittee.SECoast-Surrey@nhs.net), ref: 18/LO/1196

Study design

Single-centre randomized unblinded parallel pilot trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Mild cognitive impairment and hearing loss

Intervention

Hearing intervention: Home based hearing aid fitting and one-to-one adherence support over 12 weeks.

Healthy Ageing Intervention: Home-based, one-to-one sessions with a researcher (matching the intensity of social contact of the Hearing Intervention) on behavioural changes that can promote healthy ageing and may reduce risk of progression from MCI to dementia (blood pressure, diet, physical activity, healthy bones, joints and muscles).

Participants will be randomised to either the Hearing Intervention or Healthy Ageing Intervention by computer programme on a 1:1 ratio.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

This pilot trial aims at establishing the feasibility of a full-size trial of the hearing aid intervention versus healthy ageing intervention in people with MCI. The pilot’s primary objective is therefore to establish feasibility of recruitment, randomisation, retention, and the acceptability of the trial interventions as follows:
1. Recruitment and randomisation: Proportion of eligible participants who are randomised into the trial
2. Retention: proportion of participants who are followed for the 6 months of trial duration, and endpoint measures are obtained
3. Acceptability of the Hearing Intervention: proportion of participants allocated to the Hearing Intervention completing ≥2 intervention sessions

Secondary outcome measures

1. Proportion of participants maintaining hearing aid use, defined as a minimum of 4h a day on average since last trial assessment (when at home and in usual health) as established by data-logging at 6 months (end of trial), based on the hearing aid with the highest average use (as each participant has two hearing aids). Self-reported hearing aid use may also be employed if needed, for instance, if no data-logging is available for a participant
2. Participants rating of the interventions based on Likert scale scores.
3. Cognitive scales and the following other trial outcomes:
3.1. Delayed word recall test (DWRT): encoding and recall
3.2. Addenbrooke Cognitive Examination (ACE-III)
3.3. Trail Making Test (TMT) Part A and B
3.4. Self-reported hearing disability - Hearing Handicap Inventory for the Elderly – Screening version (HHIE-S)
3.5. Geriatric depression scale (GDS)
3.6. Quality of life questionnaires: Short Form 36 and EQ-5D
3.7. Items of the Lawton – Brody Instrumental Activities Of Daily Living Scale (I.A.D.L.): A. Telephone, F. Transport, G. Medication, H. Finances
3.8. Social function scale SF-DEM – patient rated version
3.9. UCLA Version 3 Loneliness Scale
3.10. Grip strength
3.11. Accelerometer
4. Communication Partner (when available):
4.1.The Hearing Impairment Impact–Significant Other Profile
4.2. Health-related quality of life of communication partner with SF36 and EQ-5D
4.3. Hospital anxiety and depression HADS
4.4. Carer-rated version of the SF-DEM
4.5. Brody Instrumental Activities Of Daily Living Scale
5. Number of potential participants referred to the study researchers, screening visits scheduled and completed
6. Feasibility of the schedule of assessments, which will include proportion of completed interviews and completion rates of instruments and questionnaires, as well as relevant biometric data
7. Completion rates of the interventions by recording the proportion of participants who completed the intervention, any refused or discontinued visits for the Hearing Intervention and Healthy Ageing Intervention, and any refused or discontinued tests and instruments from the schedule of assessments
8. For the Hearing Intervention, we will record the number of participants with hearing aid fitted within 3 months and reported side effects
9. Average hearing aid daily use measured as number of hours of use on average over 7 days (when at home and in usual health) as established by data-logging at 6 months (end of trial) for the Hearing Intervention and Healthy Ageing Arms. Self-reported hearing aid use may also be employed if needed, for instance if no data-logging is available for a participant, as further specified in the Statistical Analysis Plan
10. Number of unscheduled contact with participants, including type of contact (face to face or other) and whether this was with RA or research audiologist
11. Number of hearing aids lost by participants in the intervention and control arm
12. ROC analysis of HearCheck and Shoebox audiometry relative to gold standard full audiometric testing conducted by the trial audiologist, on the detection of hearing loss as defined for this trial (four-frequency pure tone average (0.5, 1, 2, 4 kHz) in the better-hearing ear of >= 25 decibels Hearing Level (dB HL) and <70 dB HL or a pure tone audiometric threshold at 4 KHz in the better ear of >= 30 decibels dB HL)
13. Reported side effects

Overall trial start date

01/02/2018

Overall trial end date

28/02/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Clinical diagnosis of MCI following internationally recognised clinical criteria (ICD 10), as diagnosed (or confirmed) by an NHS memory Service and not superseded by a diagnosis of dementia
2. 55 years of age or older (as MCI under 55 is rarely linked to neurodegeneration and future dementia)
3. Living in the community (not in hospital or residential care)
4. Mental capacity to provide informed consent to trial procedures
5. Audiometric hearing impairment. Participants must have adult-onset hearing impairment with a four-frequency pure tone average (0.5, 1, 2, 4 kHz) in the better-hearing ear of >= 25 decibels Hearing Level (dB HL) and <70 dB HL or a pure tone audiometric threshold at 4 KHz in the better ear of >= 30 decibels dB HL
6. Phoneme Recognition in Quiet score ≥60% in better ear. A phoneme recognition in quiet score <60% suggests hearing impairment that may be too severe to benefit from conventional amplification devices such as hearing aids
7. No previous prescription of hearing aids, or, if the potential participant has been prescribed hearing aid in the past, they report no hearing aid use at all in the past month (see temporary exclusion criteria number 8a under temporary exclusion criteria), or low use because of lack of perceived efficacy. Low use is defined as less than 2 hours per day on average over the past 7 days (when at home and in usual health).
8. Willingness to participate, be randomized and adhere to the protocol. Participants must be willing and able, in the opinion of the researchers, to consent to participate in the trial, to be randomized, and to adhere to the trial protocol, including willingness to wear hearing aids on a daily or near daily basis if allocated to the intervention arm, and to be followed for the duration of the trial (30 weeks)

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

76

Participant exclusion criteria

1. Spoken or written English is not sufficient for trial procedures, including reading of the trial materials, in the opinion of the research team
2. Diagnosis of hearing loss with onset in childhood (<18 years of age) as reported by the patient during the initial clinical interview
3. Participant meets ICD-10 criteria for current substance use disorder (abuse or dependence) or alcohol-related brain damage
4. If the audiological assessment shows that the participant meets criteria for onward medical referral (according to British Academy of Audiology criteria), and the issue has not already been investigated or addressed, we will request their permission to write to their GP with the results of our assessment and recommendation for referral. Where clinically appropriate the participant will continue in the trial, or the participant may be temporarily or permanently excluded based on the audiologist’s clinical judgement as to whether the issue identified is a contraindication for hearing aid treatment.’
5. Presence of conductive hearing impairment as determined by standard audiological assessment using the difference between air audiometry and bone audiometry (“air-bone gap”) greater than 20 dB over at least 4 frequencies of 0.5,1,2,3,4 KHz on both ears, as well as tympanometry and tuning fork test (British Academy of Audiology, 2017). Because the impact of a conductive (versus a sensorineural) hearing loss on cognitive functioning may potentially differ and programming for hearing aids differs for conductive hearing loss, participants with permanent conductive hearing loss are excluded from the trial
6. Unwillingness or inability, in the opinion of the researchers, to complete trial procedures and/or wear hearing aids on a daily or near daily basis.
7. Concurrent participation in other interventional research: participants will be excluded if they are already participating in another trial
8. Temporary Exclusion Criteria:
8.1. Potential participants will be excluded if hearing aids were prescribed in the past three months, irrespective of their use; however, we will contact these potential participants again after 3 months following prescription of their hearing aids and they will be eligible if they report no or low use of hearing aids. Low use is defined as less than 2 hours per day on average over the past 7 days (when at home and in usual health)
8.2. Participants determined to have occluding cerumen as per otoscopy. These participants may be enrolled after cerumen removal. We will advise participants with occluding cerumen to access accredited cerumen removal services, following recent NICE guidelines (https://cks.nice.org.uk/earwax, and “Hearing loss in adults: assessment and management”; NICE Guideline, June 2018 [NG98]). Participants who are identified as needing cerumen removal will be advised to consult their GP to arrange cerumen removal. They will also be offered reimbursement if they choose to have privately arranged cerumen removal by an accredited provider instead. If practicable, and at the discretion of the trial audiologist, participants may also be offered cerumen removal by the trial audiologist, who has undergone necessary training for cerumen removal procedures

Recruitment start date

22/10/2018

Recruitment end date

31/08/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
Division of Psychiatry Wing A, 6th Floor Maple House 149 Tottenham Court Road
London
W1T 7NF
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
1st Floor
Maple House
Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 (0)20 3447 5557
uclh.randd@nhs.net

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Alzheimer’s Research UK

Alternative name(s)

ARUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

30/06/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/02/2020: Trial’s existence confirmed by NHS HRA London - Surrey Research Ethics Committee.