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Evaluation of the effects and economic evaluation of hearing intervention on the elderly with cognitive frailty: a non-randomized controlled trial

Evaluation of the effects and economic evaluation of hearing intervention on the elderly with cognitive frailty

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067070
Enrollment
Unknown
Registered
2022-12-26
Start date
2022-12-30
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitive frailty

Interventions

Intervention group:Over-the-counter (OTC) hearing aids and health education of hearing aids based on Health Belief Model
Control group:Health education

Sponsors

School of Nursing, Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged 65 years old and more; 2. Subjects with cognitive frailty; 3. Both ears are mild to moderate sensorineural hearing loss. It means that both ears' average hearing loss at 0.5, 1, 2, and 4 kHz are 26~60 dBHL as measured using air conduction pure-tone audiometry, and the hearing loss is determined as a sensorineural hearing loss by pure-tone audiometry and tympanometry. 4. Subjects who take part in this study voluntarily; 5. Subjects who commit to using a hearing aid every day.

Exclusion criteria

Exclusion criteria: 1. Subjects have a severe disease that limits continuous participation in or completion of 3-month follow-up; 2. Subjects with contraindications of the use of hearing aids (such as progressive or fluctuating hearing loss, sudden hearing loss within the last three months, accompanied by otorrhea, earache, vertigo or headache, congenital or traumatic deformity, etc.); 3. Subjects with a history of using hearing equipment (such as hearing aids, non-prescription hearing equipment, etc.) in the past one year; 4. Subjects participating in other clinical research on hearing, cognitive function, or frailty.

Design outcomes

Primary

MeasureTime frame
Global cognitive functions;frailty;

Secondary

MeasureTime frame
Cognitive function in specific domains;Subjective Cognitive Decline;Physical function;hearing;Compliance of the HAs application;Effectiveness of the HAs application;Cost;utility;Incremental cost effective ratio;

Countries

China

Contacts

Public ContactZheng Li

School of Nursing, Peking Union Medical College

zhengli@pumc.edu.cn861088771006

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026