Clinical trial NCT02294513: Hearing Instruments in Alzheimer's Disease
Official title: Hearing Intervention for Patients With Early-Stage Alzheimer's Disease: Determining the Benefits for Patients and Family Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Hearing Loss
Keywords: Alzheimer disease
Dementia
Hearing loss
Correction of hearing impairment
Hearing aids
Communication
Family caregivers
Third-party disability
Lead sponsor: Phonak AG, Switzerland
Sponsor class: INDUSTRY
Collaborators: name: University of Toronto
name: Baycrest Centre for Geriatric Care
First posted: 2014-11-19
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clients of geriatric hospital and residential living

Brief summary: There is a strong connection between hearing loss and cognitive impairment, particularly dementia, in old age. Worldwide, dementia affects approximately 5% of persons over the age of 65 years. Hearing loss is even more prevalent in old age, affecting an estimated one third of persons over the age of 65 years. Thus, there is likely a large degree of overlap between the impairments. Indeed, this overlap may influence older adults' everyday functioning, communication, social engagement and quality of life, as well as influencing the well-being of their family caregivers. This project will examine whether patients with hearing loss and Alzheimer's disease, the most common form of dementia, derive benefit the from hearing aids prescribed and fit to them following current best practice procedures in a geriatric audiology clinic. For the first time, a formal evaluation of the potential benefits of hearing aids for the patients' family caregivers will also be conducted.

Detailed description: Currently, five percent of individuals over the age of 65 suffer from Alzheimer's disease (AD) or a related dementia. Given that hearing loss affects approximately one third of individuals over the age of 65, it is likely that many persons with AD will also suffer from co-morbid hearing loss. Following this logic, a small proportion of the patients treated in a geriatric audiology clinic most likely have both AD and hearing loss. Little research has examined the use of hearing aids by persons with AD, and whether current audiologic rehabilitation can provide benefits for their cognitive, social, and communication functioning. In addition, given that caregiver burden is a huge issue for caregivers of persons with AD, this study will examine whether providing hearing aids to those with AD has concomitant benefits for their family caregivers (e.g., spouse, adult child).

The main research question in this study is: Will persons with AD demonstrate benefit from the use of hearing aids, where benefit is measured through questionnaires assessing activities of daily living, communication, and social functioning. We hypothesize that participants with AD in the intervention group (i.e., those who receive hearing aids) will have a larger improvement in overall functioning at the end of a one-month and three-month period than participants with AD in two control groups. Furthermore, we hypothesize that a group of cognitively normal control participants will demonstrate similar gains in functioning to those participants with AD. Finally, we hypothesize that a similar disparity in benefit between the intervention and control groups will be seen for the participants' caregivers. The specific objectives for this project are to determine, for people with AD if ... a) they can benefit from hearing aids based on common audiologic outcome measures, as well as measures of communication function and activities of daily living, and if such benefits depend on variations in current audiologic practice; b) they can benefit from hearing aids with regard to measures of severity of cognitive, behavioural and psychological symptoms of dementia and related caregiver burden; c) hearing aids can bolster their family caregivers' psychological well-being, relationship with, and perceived burden related to caring for and communicating with someone who suffers from both AD and hearing loss, and if specific issues related to communication and audiologic rehabilitation are identified as important by caregivers; and d) the beneficial effects of the hearing aid intervention on the person and their caregiver can be maintained at three months post-fitting.

A randomized control design will be used with three groups of AD patients randomly assigned to 1) intervention (immediate hearing aid fitting), 2) wait-list control (no hearing aid intervention) or 3) active control (no hearing aid intervention + using a new form of fitness technology). A final group of controls with normal cognition will also be tested. All participants will undergo an assessment of their cognition. They and their family caregivers will complete a battery of measures on at least three occasions: once right before the hearing aid fitting is completed to provide a baseline (1), as well as one-month (2) and three-months (3) post-fitting. Participants in the control groups will also complete a set of additional assessments corresponding to the timeline for the hearing aid fitting of participants in the interventions groups (i.e., they will complete 5 assessments rather than 3). In addition to the study sessions, all participants will also complete standard audiology appointments including hearing testing, hearing aid evaluation, hearing aid fitting, and hearing aid checking.

Eligibility criteria: Inclusion Criteria:

* Referred to the Audiology department by a physician with a confirmed diagnosis of Alzheimer's disease (or no diagnosis of AD if a normal cognition participant)
* Pure-tone threshold at 3 kHz in excess of 35 dB HL in the worse ear
* 60 years of age or older
* Able to read and communicate well in English
* Allow the researchers access to their medication list throughout the study to assess any changes in medications
* Willing to use one or more hearing aid(s) on a regular basis
* Has a caregiver who...

  * Is a family member
  * Is over the age of 18
  * Is able to read and communicate well in English.
  * Accompanies participant to Baycrest for all necessary appointments
  * Provides qualitative and quantitative assessments of the participant's everyday behaviours and functioning
  * Is willing to learn and support the participant in using hearing aid(s), provide information on their own well-being and communication function
  * If they currently use one or more hearing aid(s), have acquired said aid(s) at least one year prior and are using it/them in a stable fashion.

Exclusion Criteria:

* Suffered a traumatic brain injury or stroke within the past five years
* Has a history of untreated psychiatric illness
* Has an uncorrected deficit in visual acuity or an untreated visual medical issue (e.g., glaucoma, macular degeneration, diabetic retinopathy)
* Suffers from a neurological disorder (e.g., multiple sclerosis, epilepsy)
* Has any untreated medical conditions that could jeopardize participation in the study
* Has been taking medication for their cognitive impairment (e.g., cholinesterase inhibitor, NMDA receptor antagonists) for less than one month.
* Has a caregiver who...

  * Is not cognitively stable (e.g., has been diagnosed with mild cognitive impairment or dementia)
  * Has a terminal medical or untreated psychiatric conditions that could jeopardize their participation in the study.

Primary outcomes:
measure: Client Oriented Scale of Improvement (COSI): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Hearing Handicap Inventory of the Elderly (HHIE): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: International Outcome Inventory for Hearing Aids (IOI-HA): Change over 2months
timeFrame: 1st, 3rd month for AD_HI & NC_HI (4th, 6th month for controls AD_WaitC & AD_ActC resp.)
measure: Self-Assessment of Communication (SAC): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Satisfaction with Amplification in Daily Life (SADL): Change over 2months
timeFrame: 1st, 3rd month for AD_HI & NC_HI (4th, 6th month for controls AD_WaitC & AD_ActC resp.)
measure: Significant Other Assessment of Communication (SOAC): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Significant Other Scale for Hearing Disability (SOS-Hear): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Secondary outcomes:
measure: Words-in-noise test (WIN): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Dichotic digits test (DDT): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Montreal Cognitive Assessment (MoCA): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Hopkins Verbal-Learning Test (HVLT): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Brief Visuospatial Memory Test-R (BVMT): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Behavioural Pathology in Alzheimer's disease (BEHAVE-AD): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Neuropsychiatric Inventory Brief (NPI-Q): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Positive and Negative Affect Schedule (PANAS): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Geriatric Depression Scale- Short Form (GDS-S): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Bristol Activities of Daily Living Scale: Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Activity and Social Participation Assessment: Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Quality of Life in Alzheimer's disease: Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Practical Hearing Test- Revised: Change over 2months
timeFrame: 1st, 3rd month for AD_HI & NC_HI (4th, 6th month for controls AD_WaitC & AD_ActC resp.)
measure: Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids: Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Perception of Conversation Index- Dementia of the Alzheimer Type: Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Relationship Satisfaction Questionnaire (RAS): Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Social Support Questionnaire: Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Zarit Burden Interview- Short Form: Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Short-Form Health Survey-12 items: Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
measure: Hours of hearing aid use: Change over 3months
timeFrame: 0, 1st, 3rd month (plus 4th and 6th month for controls AD_WaitC & AD_ActC)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Center of Geriatric Care
state: Ontario
Study officials:
affiliation: University of Toronto
name: Kathleen Pichora-Fuller, Prof.
role: PRINCIPAL_INVESTIGATOR
References: