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Completed

NCT Number: NCT06395857

Visual Arts-based Intervention for Community-dwelling Stroke Survivors

Stroke is the major cause of disability worldwide and 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 investigate the effects of a theory-driven visual arts-based intervention on community-dwelling stroke survivors' psychosocial outcomes. A two-arm randomised controlled trial will be conducted. This is a feasibility trial to test the preliminary effects of this intervention and assess its feasibility and acceptability.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Psychosocial Problem Self Efficacy Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Dia "Brilho da vida"

Macao, 999078, Macau

About this study

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 social network.

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 2 times at baseline (T0) and post-intervention (T1).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • The total score of 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

Exclusion criteria

  • 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

Treatment and study plan

Visual arts-based intervention

Other

This visual arts-based intervention is grounded on Bandura's Self-Efficacy Theory. It consists of four weekly group and face-to-face sessions delivered by a qualified facilitator. The contents of the intervention involve structured visual art-making activity, group discussion, and workbook assistance.

Primary outcomes

  1. Self-efficacy

    Time frame: Change from baseline (T0) to immediately (T1) after completion of the intervention

    The Chinese General Self-efficacy Scale (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.

Secondary outcomes

  1. Psychological distress

    Time frame: Change from baseline (T0) to immediately (T1) after completion of the intervention

    The Chinese Depression Anxiety and Stress Scale 21-items (C-DASS-21) will be adopted to measure participants' psychological distress. The score calculates the stress, depressive symptoms, and anxiety in five-level in each subscale: (1) normal; (2) mild; (3) moderate; (4) severe; and (5) extremely severe. The higher scores represent more negative moods. The total scale has a Cronbach's alpha coefficient of 0.92, and the depression, anxiety, and stress subscales have a Cronbach's alpha coefficient of 0.83, 0.80, and 0.82, respectively, which indicates good reliability and validity.

  2. Social Network

    Time frame: Change from baseline (T0) to immediately (T1) after completion of the intervention

    The Mandarin Stroke Social Network Scale (M-SSNS) will be adopted to measure participants' social networks. The scale concerns the size and composition of network, frequency of contact, proximity, and satisfaction with the six domains: children, friends, relatives, neighbours, community, and loneliness. The score of each item is from 0 to 100. The final score of the M-SSNS is the mean score of all items. The final scores range from 0 to 100. A lower score indicates few social ties and less social support. The M-SSNS has a high Cronbach's alpha coefficient of 0.7192, which indicates good reliability and validity.

  3. Health-related quality of life

    Time frame: Change from baseline (T0) to immediately (T1) after completion of the intervention

    The abbreviated Chinese World Health Organization Quality of Life-BREF (C-WHOQOL-BREF) will be adopted to measure participants' quality of life. This scale consists of 26 items: Two items assess the overall quality of life and general health, and the remaining 24 items were categorised into four domains, including physical health, psychological health, social relationships, and environment. The items are scored from 1 to 5. The average score for each area is between 4 and 20. The higher the total score means the better the quality of life. The C-WHOQOL-BREF has a high Cronbach's alpha coefficient of 0.64 to 0.88, which indicates good reliability and validity.

Other outcomes

  1. Recruitment rate

    Time frame: Before baseline (T0)

    Calculated by percentage.

  2. Retention rate

    Time frame: Change from baseline (T0) to immediately (T1) after completion of the intervention

    Calculated by percentage.

  3. Completion rate

    Time frame: Change from baseline (T0) to immediately (T1) after completion of the intervention

    Calculated by percentage.

  4. Adherence rate

    Time frame: Change from baseline (T0) to immediately (T1) after completion of the intervention

    Calculated by percentage.

  5. Satisfaction with engagement in the visual arts-based intervention

    Time frame: Immediately (T1) after completion of the intervention

    Investigated by interview.

Sponsors and collaborators

Lead sponsor

The Nethersole School of Nursing

Other

Registry information

Official study title

Feasibility Study of Visual Arts-based Intervention on Psychosocial Outcomes Among Community-dwelling Chinese Stroke Survivors

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 2, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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