Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT07071168
Brief Summary:
Background
By 2050, approximately 2.5 billion people are expected to experience some degree of age-related hearing loss (ARHL). Greater ARHL is associated with decreased communication, reduced physical activity and social engagement, increased depressive symptoms, cognitive decline and a higher risk of dementia. While previous studies highlight the benefits of combing hearing training and physical activity for older adults with ARHL, existing interventions are very limited. Additionally, the development of previous interventions often lacks end-user involvement, resulting in low adherence.
Objectives
This study aims to co-design a hearing-physical activity dual-task training app with older adults with ARHL, the potential end-users; to assess the feasibility and acceptability of the app using based on the theoretical framework of acceptability; and to examine its preliminary effects on improving physical activity, communication, loneliness, depressive symptoms and cognitive functions for older adults with age-related hearing loss.
Hypothesis to be tested
The app is feasible and acceptable to participants. Upon completing the 10-week intervention, the intervention group will report significantly greater improvements in physical activity, communication, loneliness, depressive symptoms and cognitive functions than the control group. These findings will support subsequent investigations in a larger-scale randomized controlled trial.
Research Design and Methods
This study consists of three phases. Phase 1: co-develop a prototype app that combines hearing and physical activity dual-task trainings, incorporating a music therapy component for older adults with ARHL. Co-design workshops will be conducted following the community-based participatory research methodology, where participants will engage in plenary and breakout sessions. Phase 2: conduct a two-arm, single-blinded, pilot randomized controlled trial. Phase 3: conduct individual semi-structured interviews immediately after the intervention. Four process evaluation outcomes will be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators. Participants will include Chinese adults aged 60 years or older, with mild-to-moderate HL with a pure-tone average of 20-50 dB across octave frequencies 0.5 to 4kHz in both ears.
Main outcome measures Physical activity levels.
Data analysis
Descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used.
Expected results
A hearing-physical activity dual-task training app prototype, available in both Cantonese and Mandarin, will be co-designed, tested and refined to a final version. Participants could benefit from incorporating tailored intervention for physical activity with auditory rehabilitation.
Study:
NCT07071168
Study Brief:
Protocol Section:
NCT07071168