Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2018
INTERVENTION: Hearing Intervention: The intervention consist of three parts: (i) hearing assessment and hearing aid (HA) discussion, (ii) HA fitting, verification and validation and (iii) HA review following daily use of HAs. The intervention will be carried out by a qualified audiologist according to the Australian Audiological Society Standards in a standardised sound proof booth. Mode of delivery‐ face‐to‐face Location: Ear Science Institute Australia‐ Lions Hearing Clinics in Nedlands, Subiaco, Mt Lawley, Joondalup and Bunbury. Part I: Hearing assessment and HA discussion Duration 1.15 hours. During the first appointment, the participant will complete (1) a comprehensive case history that contains information on medical and hearing history, ear infections, ear surgeries, head trauma, noise exposure, ototoxic drug exposure, visual and dexterity problems, tinnitus, vertigo, and cognition. (2) Client Oriented Scale of Improvement (COSI) goals for everyday listening situations and a standard hearing assessment. Finally, the audiologist will discuss with participants currently available technology of HAs that include suitable type and style of HAs and their cost, as well as participant’s daily listening expectations. The choice of hearing aid will be based on hearing loss, subject preference and ease of management. An explanation on what are hearing aids and how they work, what they are used for, how to use them, and questions and answers will be provided. Study participants receiving the intervention will also be given an educational booklet summarising the topics presented. (How we hear‐prepared by Ear Science Institute Australia). A HA is a device designed to improve hearing by amplifying and acoustically modifying the sound to suit a person’s hearing loss. Current HA technology uses digital signal processing techniques to improve speech intelligibility and provide comfort for the user. Part II: HA fitting, real‐ear verification and validation‐ within a week of attending the appointment part I‐ will be carried out by a qualified audiologist. Duration: 1 hour. The audiologist will program the HA and carry out the real‐ear verification using real ear insertion gain (REIG) to ensure that appropriate amplification is provided to a person with hearing loss. The HA program will be fine‐tuned to fit the participants’ every day listening demands using NAL‐NL2 formula. Following, HA out‐put verification, validation tasks will be carried out to determine that the participant is benefiting from the HAs. Validation includes asking the patient about sound quality, ear balance, comfort of the devices and finally a speech in quiet assessment using AB word list will also be carried out to determine that the participants is benefiting from the HAs. Adjustments can be made to the devices so that the patient is comfortable with the devices. Part III: HA review: 2 weeks after the HA fitting‐ will be conducted by a qualified audiologist Duration: 30 minutes. HA data logging information recorded in the software of the HA is analysed to ensure that the HA program provides the best solutions to the listening demands of the participant. Based on COSI goals, data logging information and feedback received from the participants, changes are made to the HA program. The participants will not attend any other assessments after part III. However, they will attend annual review appointments during which hearing will be assessed and changes to the hearing aid program will be carried out by the audiologist. CONDITION: Cognitive Impairment Dementia Hearing Loss PRIMARY OUTCOME: Global cognitive functions‐ Montreal Cognitive Assessment for the Hearing Impaired (MoCA‐H). INCLUSION CRITERIA: Participants will be older adults aged 70 years or older (cognitive decline is more pronounced later in life). Measuring adherence with treatment: Current HAs have a “log in” feature that records both the average number of hours and different listening environments in which the participant has used the HA. These data can be retrieved when the HA is connected to the program software, which will be done at all assessments. In addition, the participant will be asked to maintain a daily listening diary in which s/he records the number of hours the HA worn. SECONDARY OUTCOME: 1. Cognitive functions ‐ executive functions, episodic memory, spatial working memory & short‐term visual recognition memory will be assessed using Cambridge Neuropsychological Test Battery (CANTAB). ; 10. Psychological and social adjustment problems resulting from hearing loss: Hearing Handicap Inventory of the Elderly (HHIE) 11. Effectiveness of the HAs application: International Outcome Inventory for HAs (IOI‐HA) 2. Health status and Quality of life: Short form survey (SF‐12) 3. Physical function: Functional Comorbidity Index (FCI) 4.Depressive symptoms: Patient Health Questionnaire (PHQ‐9) 5. Anxiety symptoms: Geriatric Anxiety Inventory (GAI) 6. Daily living function: Lawton & Brody Instrumental Activities of Daily Living (IADL) 7. Social Support and interaction: Berkman Syme Social Network Index (SNI) 8. Loneliness: de Jong Gierveld Loneliness scale 9. Physical function‐grip strength‐will be measured using a hand held dynamometer Health economic cost analysis: We will use administrative health linkage data to ascertain contact with hospital services (planned and unplanned), the reason for contact and length of stay and procedures. Costs will be calculated according to the Medicare Medical Schedule. Montreal Cognitive Assessment for the Hearing Impaired (MOCA‐H) greater than or equal 18 and lesser than 26 (mild impairment). Better ear average hearing loss at 0.5, 1 & 2 kHz (3FAHL) equal to or greater than 23 dB or high frequency average hearing loss (2, 3 & 4 kHz) (HFAHL) equal to or greater than 40 dB as measured using air conduction pure‐tone audiometry. We have followed the HA fitting criteria recommended by Office of Hearing Services Australia for older adults with ARHL. Fluent English speakers
Epistemonikos ID: 868960de33cb3ad5e2834543bae14891beaefe0c
First added on: Aug 25, 2024