Unlocking Limitations Through Arts: A Mixed Methods Study on the Effectiveness of an Expressive Arts-based Intervention on Psychosocial Wellbeing of Adults With Age-related Visual Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Change of Baseline Psychosocial Adaptation Questionnaire for visual impairment level at 2 months, 5 months, and 8 months
研究概览
简要总结
Age-related Macular Degeneration (AMD) is an age-related eye disease resulting in vision loss. Persons with AMD not only experience a gradual loss of ability in independent living, but also profound impairment in psychosocial well-being.The multimodal, expressive arts-based intervention (EXABI) that emphasizes imagination and creativity can be an engaging, enjoyable, and safe process of empowerment. This study aims to investigate the effectiveness and process of an expressive arts-based intervention in enhancing psychosocial wellness and adjustment to gradual vision loss of persons with AMD. This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group.
详细描述
Age-related Macular Degeneration (AMD) is an age-related eye disease resulting in vision loss. Persons with AMD not only experience a gradual loss of ability in independent living, but also profound impairment in psychosocial well-being. Given the impacts of irreversible visual loss, persons with AMD need to actively adapt to changes and renegotiate supportive relations to maintain well-being. Psychosocial enhancement may buffer against the deteriorating quality of life, psychological distress, and poor adjustments among adults with AMD. The multimodal, expressive arts-based intervention (EXABI) that emphasizes imagination and creativity can be an engaging, enjoyable, and safe process of empowerment. The EXABI could help bypass or expand the limit of vision during interaction, and broaden the coping repertoire of those with AMD.
This study aims to investigate the effectiveness and process of an expressive arts-based intervention in enhancing psychosocial wellness and adjustment to gradual vision loss of persons with AMD. Primary outcomes include psychosocial adaptation, and vision-related quality of life; and secondary outcomes including symptoms of depression and anxiety, resilience, social support, and imagination as well as associations between psychosocial variables, participants' experience in the group, and factors affecting the effectiveness of the EXABI will be explored.
This proposed study adopts a randomized controlled trial with mixed methods design. To address the research objectives, data collected will be triangulated and interpreted simultaneously to address the research questions. Outcome measures will be assessed on four time-points (T0: Pre-intervention at baseline; T1: Post-intervention; T2: 3-month post-intervention and; T3: 6-month post-intervention) to assess the immediate and sustained effects of the expressive arts-based intervention on psychosocial wellbeing of the participants. Qualitative interviews will be conducted with a random subsample of 30 participants from the expressive arts group at T1 and T3 to collect fine-grained, information to explore their overall experience of participation in the intervention and how the experience has shaped their coping experience in terms of stress management, self-care challenges, and to reestablish severed social connections. Results of the qualitative interviews will be used to enhance the interpretation and understanding of the quantitative findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of this trial, neither the staff, participants nor care provider can be masked to allocation. The data analyst will be blinded after study completion by having the intervention group information coded.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are community-dwelling, Chinese-speaking adults aged between 50 and 80, with the diagnosis of age-related macular degeneration in one or both eyes of all different etiologies
排除标准
- •Inability to understand the Chinese language, as well as a diagnosis of total blindness, presence of other significant physical, psychological, and cognitive comorbidities that would hinder the participant from completing the study will be excluded.
结局指标
主要结局
Change of Baseline Psychosocial Adaptation Questionnaire for visual impairment level at 2 months, 5 months, and 8 months
时间窗: Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8)
Administration of the Chinese translated version of the 38-item Psychosocial Adaptation Questionnaire: * The first factor was attitude, involving 10 items. The second factor was self-acceptance, involving six items. The third factor was self-esteem involving six items. The fourth factor was anxiety/depression, involving six items. The fifth factor was belonging, involving five items. The sixth factor was self-efficacy involving three items. The last factor was the sense of self-control, involving two items. * Higher scores indicate a higher level of endorsement in a specific domain. * Likert's scale with four points was used to quantify results. The four points included completely incorrect, more correct, most correct, and completely correct. The score for positive items was one point, two points, three points, and four points; negative items were scored oppositely. * Q14, Q17, Q19, Q20, Q21, Q22, Q29, Q30, Q31, and Q32 are reversed (positive) items.
Change of Baseline Vision-related Quality of Life level at 2 months, 5 months, and 8 months
时间窗: Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8)
Administration of the Chinese translated version of the 13-item Vision-related Quality of Life Scale: * Vision-specific quality of life is measured by the 13-item Vision-Related Quality of Life Scale taken from 25-item National Eye Institute Visual Function Questionnaire. * Social functioning of Vision-specific quality of life is Q11 and Q13 respectively. * Mental health of Vision-specific quality of life is Q3, Q25, Q21, and Q22 respectively. * Role limitation of Vision-specific quality of life is Q17 and Q18 respectively. * Dependency of Vision-specific quality of life is Q20, Q23, and Q24 respectively. * Ocular pain of Vision-specific quality of life is Q4 and Q19 respectively. * Original numeric values from the survey are re-coded following the scoring rules. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 1
次要结局
- Change of Baseline Anxiety level at 2 months, 5 months, and 8 months(Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8))
- Change of Baseline Depression level at 2 months, 5 months, and 8 months(Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8))
- Change of Baseline Resilience level at 2 months, 5 months and 8 months(Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8))
- Change of Baseline Perceived Social Support level at 2 months, 5 months and 8 months(Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8))
- Change of Baseline Imagination level at 2 months, 5 months, and 8 months(Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8))