Clinical trial NCT05806658: A Theory-driven Visual Arts-based Intervention for Community-dwelling Stroke Survivors
Official title: A Theory-driven Visual Arts-based Intervention on Psychosocial Outcomes Among Community-dwelling Chinese Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Psychosocial Problem
Keywords: Stroke
Psychosocial functioning
Self-Efficacy
Lead sponsor: The Nethersole School of Nursing
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomised controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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).

Eligibility criteria: 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. 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

Primary outcomes:
measure: General Self-efficacy as assessed by the General Self-efficacy Scale (Chinese version)
timeFrame: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
Secondary outcomes:
measure: Psychological distress (Depression, anxiety, and stress) as assessed by the Depression Anxiety and Stress Scale 21-items (Chinese version)
timeFrame: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
measure: Social participation as assessed by the social domain Stroke Impact Scale 3.0 (Mandarin version)
timeFrame: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
measure: Health-related quality of life as assessed by the World Health Organization Quality of Life-BREF (Chinese version)
timeFrame: Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
Other outcomes:
Locations:
city: Macau
country: Macau
facility: Pou Tai Elderly Service
Study officials:
affiliation: Chinese University of Hong Kong
name: Mimi Wai Man Mimi Wai Man, MSc
role: PRINCIPAL_INVESTIGATOR
References: