About this trial
This study will evaluate a new collaborative elderly hearing-loss service in Hong Kong. The service is based in Family Medicine (FM) and supported by Ear, Nose and Throat (ENT) specialist nurses and audiology services. It aims to provide earlier hearing assessment, counselling, hearing-aid referral or fitting where appropriate, and referral to ENT specialists when more complex ear problems are suspected.
The study will compare this new service with the existing ENT elderly hearing clinic. About 500 adults aged 65 years or above with progressive hearing loss will be enrolled. Researchers will compare the time to hearing assessment and hearing-related abilities and quality of life score, satisfactory score related to the care in the FM and ENT cohort, compliance to hearing aids, and referral to ENT services. The findings may help determine whether the new service is safe, cost-effective and improves access to hearing care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 65 years or above.
Attending the Family Medicine elderly hearing clinic at Tseung Kwan O South Family Medicine Clinic or the ENT elderly hearing clinic at Specialist Outpatient Clinic at Tseung Kwan O Hospital.
Bilateral progressive hearing loss for more than 1 month without acute ear infection; or earwax impaction affecting hearing; or referred for hearing-aid assessment, prescription, fitting, or follow-up.
Able to provide written informed consent independently, or with caregiver support sufficient to facilitate completion of study questionnaires.
Disqualifiers
Sudden sensorineural hearing loss.
Acute otitis, otorrhoea, or other acute ear infection requiring urgent assessment.
Tympanic-membrane perforation.
Suspected cholesteatoma or other serious middle-ear disease.
Trial population
The study population comprises adults aged 65 years or above presenting with hearing loss to either the new Family Medicine elderly hearing clinic at Tseung Kwan O South Family Medicine Clinic or the existing ENT elderly hearing clinic at specialist outpatient clinic at Tseung Kwan O Hospital, Hong Kong. Participants will have progressive bilateral hearing loss, hearing difficulty associated with earwax impaction, or a need for hearing-aid assessment or rehabilitation. Approximately 500 participants will be recruited: approximately 100 participants in the Family Medicine clinic cohort and 400 participants in the ENT clinic cohort. The study excludes patients with urgent or complex otologic conditions that require prompt specialist ENT evaluation.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in hearing-related function measured by the Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)
Change in SSQ-12 score from baseline to follow-up. The SSQ-12 is a 12-item patient-reported measure of hearing abilities and hearing quality; higher scores indicate better self-reported hearing ability.
Change in quality of life measured by the Older People's Quality of Life Brief questionnaire (OPQOL-Brief)
Change in OPQOL-Brief score from baseline to follow-up. The OPQOL-Brief is a 13-item patient-reported measure of quality of life in older adults; higher scores indicate better quality of life.
Change in depressive symptoms measured by the 15-item Geriatric Depression Scale (GDS-15)
Change in GDS-15 score from baseline to follow-up. The GDS-15 is a 15-item self-report screening measure of depressive symptoms in older adults; total scores range from 0 to 15, with higher scores indicating more depressive symptoms.
Patient satisfaction with the hearing-care pathway
Patient satisfaction score measured using the study structured satisfaction questionnaire at follow-up. Higher scores indicate greater satisfaction with the hearing-care service received.
Secondary outcomes
Time from first presentation with hearing loss to first hearing assessment and hearing rehabilitation
Number of days from the first submission of referral for hearing loss to completion of the first hearing assessment and hearing rehabilitation, derived from Hospital Authority electronic clinical records.
Referral from the Family Medicine pathway to ENT specialist outpatient care
Proportion of participants in the Family Medicine elderly hearing clinic cohort who are referred to ENT specialist outpatient care, together with documented reasons for referral or pathway escalation.
Hearing-aid use and adherence
Proportion of participants prescribed or fitted with hearing aids who report hearing-aid use, adherence, perceived benefit, or problems at follow-up.
Sponsors and contacts
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