Stroke Clinical Trial
Official title:
Feasibility Study of Visual Arts-based Intervention on Psychosocial Outcomes Among Community-dwelling Chinese Stroke Survivors
Verified date | April 2024 |
Source | The Nethersole School of Nursing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | March 21, 2024 |
Est. primary completion date | December 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Aged 18 years old or above 2. A clinical diagnosis of first-ever or recurrent ischaemic or haemorrhagic stroke 3. At least three months after stroke onset 4. Living at home 5. The total score of Hong Kong Montreal Cognitive Assessment (HK-MoCA) above the second percentile 6. At least stage four of upper limb function was assessed by Brunnstrom recovery stages (BRS) 7. Able to remain in a sitting position on a chair or wheelchair independently or with support 8. Able to communicate with Cantonese or Putonghua 9. Able to read traditional or simplified Chinese 10. Able to provide written informed consent Exclusion Criteria: 1. Other diagnoses or diseases causing pre-existing physical disability or psychosocial problems 2. Dysphasia, hearing, or visual impairments 3. Any substance abuse affected their health status 4. Already taken a visual arts-based intervention for stroke recovery 5. Currently taking part in other research for psychosocial recovery 6. Currently receiving psychosocial therapy or intervention |
Country | Name | City | State |
---|---|---|---|
Macau | Centro de Dia "Brilho da vida" | Macau |
Lead Sponsor | Collaborator |
---|---|
The Nethersole School of Nursing |
Macau,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Recruitment rate | Calculated by percentage. | Before baseline (T0) | |
Other | Retention rate | Calculated by percentage. | Change from baseline (T0) to immediately (T1) after completion of the intervention | |
Other | Completion rate | Calculated by percentage. | Change from baseline (T0) to immediately (T1) after completion of the intervention | |
Other | Adherence rate | Calculated by percentage. | Change from baseline (T0) to immediately (T1) after completion of the intervention | |
Other | Safety of engagement in the visual arts-based intervention | Assessed by the incidence and severity of adverse events. | During the intervention process and immediately (T1) after completion of the intervention | |
Other | Satisfaction with engagement in the visual arts-based intervention | Investigated by interview. | Immediately (T1) after completion of the intervention | |
Primary | Self-efficacy | 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. | Change from baseline (T0) to immediately (T1) after completion of the intervention | |
Secondary | Psychological distress | 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. | Change from baseline (T0) to immediately (T1) after completion of the intervention | |
Secondary | Social Network | 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. | Change from baseline (T0) to immediately (T1) after completion of the intervention | |
Secondary | Health-related quality of life | 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. | Change from baseline (T0) to immediately (T1) after completion of the intervention |
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