StrokeNCT05806658
A Theory-driven Visual Arts-based Intervention for Community-dwelling Stroke Survivors
A study testing Visual arts-based intervention in people with Stroke and Psychosocial Problem, run by The Nethersole School of Nursing at 1 site in Macau.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Psychosocial Problem
- What is being tested?
- Visual arts-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteMacau
- Study dates
- 18 Sep 2023to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Macau1 site
Pou Tai Elderly Service
Macao, 999078
About this study
Official title: A Theory-driven Visual Arts-based Intervention on Psychosocial Outcomes Among Community-dwelling Chinese Stroke Survivors
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.
Read the 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 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).
- Conditions
- Stroke, Psychosocial Problem
- Being tested
- Visual arts-based intervention
- Keywords
- Stroke, Psychosocial functioning, Self-Efficacy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual arts-based interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Eligible participants will be randomly assigned to receive usual care with the four-week visual arts-based intervention. Receives: Other: Visual arts-based intervention |
| Control group | No intervention | Eligible participants will be randomly assigned to receive usual stroke care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Self-efficacy as assessed by the General Self-efficacy Scale (Chinese version)
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.
Measured: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
Secondary outcomes (3)
Psychological distress (Depression, anxiety, and stress) as assessed by the Depression Anxiety and Stress Scale 21-items (Chinese version)
The Depression Anxiety and Stress Scale 21-items (Chinese version) (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.
Measured: 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)
The social domain Stroke Impact Scale 3.0 (Mandarin version) (M-SIS 3.0) will be adopted to measure participants' social participation. The score of each item in the social domain is from 1 "all of the time" to 5 "none of the time". The final score of this subscale ranges from 8 to 40. The higher the total score means the better social participation. The total scale has a Cronbach's alpha coefficient of 0.78, and the social domain has a Cronbach's alpha coefficient of 0.83, which indicates good reliability.
Measured: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
Health-related quality of life as assessed by the World Health Organization Quality of Life-BREF (Chinese version)
The World Health Organization Quality of Life-BREF (Chinese version) (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.
Measured: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start18 Sep 2023
- Primary completion14 Dec 2024
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Nethersole School of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mimi Wai Man Chan, The Nethersole School of Nursing
- Investigators
- Mimi Wai Man Mimi Wai Man, MSc, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806658
- Sponsor's protocol ID
- 20230325-004-000
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory-driven Visual Arts-based Intervention on Psychosocial Outcomes Among Community-dwelling Chinese Stroke Survivors
- ClinicalTrials.gov ID
- NCT05806658
- Acronym / sponsor ID
- 20230325-004-000
- Conditions
- Stroke, Psychosocial Problem
- Keywords
- Stroke, Psychosocial functioning, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- The Nethersole School of NursingUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Visual arts-based interventionEligible participants will be randomly assigned to receive usual care with the four-week visual arts-based intervention. |
| Control group | No intervention | –Eligible participants will be randomly assigned to receive usual stroke care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual arts-based interventionThis 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. | Other | Intervention group |
Primary outcome
General Self-efficacy as assessed by the General Self-efficacy Scale (Chinese version)
Time frame: 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.
3 secondary outcomes
Psychological distress (Depression, anxiety, and stress) as assessed by the Depression Anxiety and Stress Scale 21-items (Chinese version)
Time frame: 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)
Time frame: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
Health-related quality of life as assessed by the World Health Organization Quality of Life-BREF (Chinese version)
Time frame: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mimi Wai Man Mimi Wai Man, MSc principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual arts-based intervention in people with Stroke and Psychosocial Problem, run by The Nethersole School of Nursing at 1 site in Macau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Macau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Self-efficacy as assessed by the General Self-efficacy Scale (Chinese version) (time frame: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.