Visual Arts-based Intervention for Community-dwelling Stroke Survivors

NCT06395857 | Completed DMC

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Self Efficacy; Psychosocial Problem

Keywords

Stroke; Self Efficacy; Psychosocial Problem

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Psychological distress

  Change from baseline (T0) to immediately (T1) after completion of the intervention

• Social Network

  Change from baseline (T0) to immediately (T1) after completion of the intervention

• Health-related quality of life

  Change from baseline (T0) to immediately (T1) after completion of the intervention

Other Outcomes (5)

• Recruitment rate

  Before baseline (T0)

• Retention rate

  Change from baseline (T0) to immediately (T1) after completion of the intervention

• Completion rate

  Change from baseline (T0) to immediately (T1) after completion of the intervention

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 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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
• 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

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)

Centro de Dia "Brilho da vida"

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 Chan, MSc

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Parallel randomised controlled trial

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 2, 2024
• Study Start: September 21, 2023
• Primary Completion: December 26, 2023
• Study Completion: March 21, 2024
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)