- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06395857
Visual Arts-based Intervention for Community-dwelling Stroke Survivors
Feasibility Study of Visual Arts-based Intervention on Psychosocial Outcomes Among Community-dwelling Chinese Stroke Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Macao, Macau, 999078
- Centro de Dia "Brilho da vida"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention group
Eligible participants will be randomly assigned to receive usual care with the four-week visual arts-based intervention.
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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.
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No Intervention: Control group
Eligible participants will be randomly assigned to receive receive usual stroke care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-efficacy
Time Frame: Change from baseline (T0) to immediately (T1) after completion of the intervention
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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.
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Change from baseline (T0) to immediately (T1) after completion of the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psychological distress
Time Frame: Change from baseline (T0) to immediately (T1) after completion of the intervention
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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.
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Change from baseline (T0) to immediately (T1) after completion of the intervention
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Social Network
Time Frame: Change from baseline (T0) to immediately (T1) after completion of the intervention
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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.
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Change from baseline (T0) to immediately (T1) after completion of the intervention
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Health-related quality of life
Time Frame: Change from baseline (T0) to immediately (T1) after completion of the intervention
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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.
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Change from baseline (T0) to immediately (T1) after completion of the intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Recruitment rate
Time Frame: Before baseline (T0)
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Calculated by percentage.
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Before baseline (T0)
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Retention rate
Time Frame: Change from baseline (T0) to immediately (T1) after completion of the intervention
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Calculated by percentage.
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Change from baseline (T0) to immediately (T1) after completion of the intervention
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Completion rate
Time Frame: Change from baseline (T0) to immediately (T1) after completion of the intervention
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Calculated by percentage.
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Change from baseline (T0) to immediately (T1) after completion of the intervention
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Adherence rate
Time Frame: Change from baseline (T0) to immediately (T1) after completion of the intervention
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Calculated by percentage.
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Change from baseline (T0) to immediately (T1) after completion of the intervention
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Satisfaction with engagement in the visual arts-based intervention
Time Frame: Immediately (T1) after completion of the intervention
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Investigated by interview.
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Immediately (T1) after completion of the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mimi Wai Man Chan, MSc, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Interventional (Oncolys BioPharma Inc)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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