A Theory-driven Visual Arts-based Intervention for Community-dwelling Stroke Survivors

NCT05806658 | Completed DMC

• 1 other identifier: 20230325-004-000
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Psychosocial Problem

Keywords

Stroke; Psychosocial functioning; Self-Efficacy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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)

  Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)

Study Arms (2)

Intervention group

EXPERIMENTAL

Eligible participants will be randomly assigned to receive usual care with the four-week visual arts-based intervention.

Other: Visual arts-based intervention

Control group

NO INTERVENTION

Eligible participants will be randomly assigned to receive usual stroke care.

Interventions

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Nethersole School of Nursing: lead

Study Sites (1)

Pou Tai Elderly Service

Macao, 999078, Macau

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mimi Wai Man Mimi Wai Man, MSc

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel randomised controlled trial

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: September 18, 2023
• Primary Completion: December 14, 2024
• Study Completion: April 8, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)