ArticleBMJ open2026
Family-supported hearing aid use behaviour intervention to improve outcomes in older adults at high risk for dementia (SOUND): study protocol for a randomised controlled trial.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundHearing loss (HL) imposes a substantial burden on families and society and is the largest modifiable risk factor for dementia. As a practical and non-invasive approach to managing HL, hearing aid use has been associated with a reduced risk of incident dementia and global cognitive decline. However, high-level evidence on the cognitive benefits of hearing aids among those at high dementia risk is scarce and adherence to hearing aid use remains challenging. Our study aims to explore whether a family-supported hearing aid use behaviour intervention, guided by the integrated framework of self-determination theory, technology acceptance model and family social support theory, can improve cognitive function in Chinese older adults with both HL and mild cognitive impairment (MCI). METHODS AND ANALYSIS: This study is a two-arm, single-blinded, randomised controlled trial. A total of 150 participants with HL and MCI will be randomly assigned in a 1:1 ratio to either an intervention group (hearing aid use and family intervention) or a control group (hearing aid use and regular health education). All interventions will last for 4 months. Hearing aid use will be delivered by professional audiologists, while family caregivers will deliver the behavioural intervention at home after receiving standardised training from researchers and guidance through structured manuals. Furthermore, family caregivers will be guided through a WeChat group to address unresolved issues related to hearing aid maintenance and intervention skills. The primary outcome is cognitive function measured by the Montreal Cognitive Assessment-Hearing Impairment at baseline and follow-up. Secondary outcomes include adherence score to hearing aid use measured by daily duration and weekly frequency, hearing aid use skills, motivation, activities of daily life, quality of life, depressive symptoms, subjective cognitive decline, social support, self-efficacy, healthcare utilisation, autonomy support and caregiver burden. ETHICS AND DISSEMINATION: The study was approved by the Institutional Review Board of Peking University. Research findings will be published in peer-reviewed journals and at national and international conferences. TRIAL REGISTRATION NUMBER: ChiCTR2400091791.
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