Ho Rainbow Tin Hung, Cheong Allen Ming Yan, Wan Adrian Ho Yin, Lo Temmy Lee Ting, Fong Ted Chun Tat, Chan Caitlin Kar Pui, Li Qing, Chan Wai Chi
Centre on Behavioral Health, The University of Hong Kong, Hong Kong, China
Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong, China.
BMJ Open. 2024 Dec 20;14(12):e088311. doi: 10.1136/bmjopen-2024-088311.
Age-related macular degeneration (AMD) is a prevalent eye disease among middle-aged and older adults. AMD leaves the patient with irreversible deteriorating vision, which profoundly impacts their daily lives and psychosocial well-being. Given the limited studies addressing the psychosocial needs of adults with AMD and, in particular, using an expressive arts-based intervention (EXABI) as an intervention, this study aims to investigate the effectiveness of such an intervention in enhancing the psychosocial well-being of adults with AMD.
This study will employ a mixed-methods randomised controlled trial design. One hundred fifty-four participants with AMD will be recruited and randomised into either the EXABI or treatment-as-usual waitlist control group. Participants will respond to a battery of measurements regarding their psychosocial condition at four time points: baseline (T), 2 months after baseline (postintervention, T), 5 months after baseline (T) and 8 months after baseline (T). A subgroup of participants will also share their experiences through in-depth interviews at T and T to help further understand the mechanism and effect of the intervention. Quantitative data will be analysed by mixed-effects models and path analysis, whereas qualitative data will be analysed by adopting the thematic analysis approach. The two sets of data will be integrated to provide a comprehensive view of the effectiveness and mechanisms of the intervention.
This study has obtained ethical approval from the Human Research Ethics Committee of the University of Hong Kong (Ref. no.: EA210606). All research procedures will be conducted upon receiving signed written consent forms from participants. The findings of the study will also be presented at international conferences and published in peer-reviewed academic journals.
NCT05675150, prospectively registered.
年龄相关性黄斑变性（AMD）是中老年人中一种常见的眼病。AMD会使患者视力不可逆地恶化，这对他们的日常生活和心理社会幸福感产生深远影响。鉴于针对患有AMD的成年人的心理社会需求的研究有限，特别是使用基于表达性艺术的干预措施（EXABI）作为干预手段的研究，本研究旨在调查这种干预措施在提高患有AMD的成年人的心理社会幸福感方面的有效性。
本研究将采用混合方法随机对照试验设计。将招募154名患有AMD的参与者，并将其随机分为EXABI组或常规治疗等待列表对照组。参与者将在四个时间点对一系列关于其心理社会状况的测量做出反应：基线（T0）、基线后2个月（干预后，T1）、基线后5个月（T2）和基线后8个月（T3）。一部分参与者还将在T0和T3通过深入访谈分享他们的经历，以帮助进一步了解干预的机制和效果。定量数据将通过混合效应模型和路径分析进行分析，而定性数据将采用主题分析方法进行分析。两组数据将整合起来，以全面了解干预的有效性和机制。
本研究已获得香港大学人类研究伦理委员会的伦理批准（参考编号：EA210606）。所有研究程序将在获得参与者签署的书面同意书后进行。本研究的结果也将在国际会议上展示，并发表在同行评审的学术期刊上。
NCT05675150，前瞻性注册。
