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临床试验/NCT05806658
NCT05806658已完成不适用

A Theory-driven Visual Arts-based Intervention on Psychosocial Outcomes Among Community-dwelling Chinese Stroke Survivors

The Nethersole School of Nursing2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2023年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
144
试验地点
2
主要终点
General Self-efficacy as assessed by the General Self-efficacy Scale (Chinese version)

研究概览

简要总结

Stroke leads to psychosocial issues for community-dwelling stroke survivors in their recovery journey. Previous studies showed the benefits of visual arts-based interventions in enhancing self-efficacy and psychosocial functions. However, the interventions were not well designed with a theoretical framework. This study will evaluate the effectiveness of a theory-driven visual arts-based intervention on community-dwelling stroke survivors' psychosocial outcomes. A two-arm randomised controlled trial will be conducted to test the effects of this intervention and assess its feasibility in the community.

详细描述

Stroke is the second-leading cause of death and the major cause of disability worldwide. With advanced progress in stroke treatment, more people with stroke now survive longer than in past decades and become stroke survivors living in the community. Improvements in stroke rehabilitation services further boost physical outcomes and increase functional independence in stroke survivors after discharge. Whereas psychosocial issues commonly persist over the recovery journey in community-dwelling stroke survivors, such as psychological distress, low self-efficacy and reduction in social participation.

Existing research suggested that enhancing self-efficacy is important to post-stroke psychosocial recovery, while the benefits of visual arts-based interventions in promoting post-stroke psychosocial functions have also been found. However, the current visual arts-based interventions were not well designed with a theoretical framework. Thus, this study will be conducted to contribute to current knowledge of the effectiveness of visual arts-based intervention grounded on Bandura's Self-Efficacy Theory on community-dwelling stroke survivors.

This current study will be conducted as a two-arm randomised controlled trial. Eligible participants will be randomised into either a four-week visual arts-based intervention group or a usual stroke care control group. The control group will continue with the usual stroke care provided by community healthcare services. Participants will be assessed 3 times at baseline (T0), post-intervention (T1), and one-month post-intervention (T2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Aged 18 years old or above
  • A clinical diagnosis of first-ever or recurrent ischaemic or haemorrhagic stroke
  • At least three months after stroke onset
  • Living at home
  • Hong Kong Montreal Cognitive Assessment (HK-MoCA) above the second percentile
  • At least stage four of upper limb function was assessed by Brunnstrom recovery stages (BRS)
  • Able to remain in a sitting position on a chair or wheelchair independently or with support
  • Able to communicate with Cantonese or Putonghua
  • Able to read traditional or simplified Chinese
  • Able to provide written informed consent

排除标准

  • Other diagnoses or diseases causing pre-existing physical disability or psychosocial problems
  • Dysphasia, hearing, or visual impairments
  • Any substance abuse affected their health status
  • Already taken a visual arts-based intervention for stroke recovery
  • Currently taking part in other research for psychosocial recovery
  • Currently receiving psychosocial therapy or intervention

结局指标

主要结局

General Self-efficacy as assessed by the General Self-efficacy Scale (Chinese version)

时间窗: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)

The General Self-efficacy Scale (Chinese version) (C-GSES) will be adopted to measure the participants' self-efficacy. Each item asks participants about their self-efficacy. Each item is rated on a four-point scale from 1 "Not at all true" to 4 "Exactly True". The total score is summed to give a range from 10 to 40, and the higher score represents greater self-efficacy. The C-GSES has a high Cronbach's alpha coefficient of 0.96, which indicates good reliability and validity.

次要结局

  • Health-related quality of life as assessed by the World Health Organization Quality of Life-BREF (Chinese version)(Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2))
  • Psychological distress (Depression, anxiety, and stress) as assessed by the Depression Anxiety and Stress Scale 21-items (Chinese version)(Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2))
  • Social participation as assessed by the social domain Stroke Impact Scale 3.0 (Mandarin version)(Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2))

研究者

发起方
The Nethersole School of Nursing
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mimi Wai Man Chan

Principal Investigator

The Nethersole School of Nursing

研究点 (2)

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