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

Primary Purpose

Stroke, Psychosocial Problem

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visual arts-based intervention
Sponsored by
The Nethersole School of Nursing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Stroke, Psychosocial functioning, Self-Efficacy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    March 28, 2023
    Last Updated
    June 16, 2023
    Sponsor
    The Nethersole School of Nursing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05806658
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Nethersole School of Nursing

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Psychosocial Problem
    Keywords
    Stroke, Psychosocial functioning, Self-Efficacy

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel randomised controlled trial
    Masking
    Outcomes Assessor
    Masking Description
    Single (Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    148 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Eligible participants will be randomly assigned to receive usual care with the four-week visual arts-based intervention.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Eligible participants will be randomly assigned to receive usual stroke care.
    Intervention Type
    Other
    Intervention Name(s)
    Visual arts-based intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    General Self-efficacy as assessed by the General Self-efficacy Scale (Chinese version)
    Description
    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.
    Time Frame
    Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
    Secondary Outcome Measure Information:
    Title
    Psychological distress (Depression, anxiety, and stress) as assessed by the Depression Anxiety and Stress Scale 21-items (Chinese version)
    Description
    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.
    Time Frame
    Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
    Title
    Social participation as assessed by the social domain Stroke Impact Scale 3.0 (Mandarin version)
    Description
    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.
    Time Frame
    Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)
    Title
    Health-related quality of life as assessed by the World Health Organization Quality of Life-BREF (Chinese version)
    Description
    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.
    Time Frame
    Change from baseline (T0) to immediately after completion of the intervention (T1), and one month after completion of the intervention (T2)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mimi Wai Man Chan, MSc
    Phone
    +85239433513
    Email
    mi350864@link.cuhk.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzanne Hoi Shan Lo, PhD
    Phone
    +85239434485
    Email
    suzannelo@cuhk.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mimi Wai Man Mimi Wai Man, MSc
    Organizational Affiliation
    Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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