NCT07350603

Brief Summary

This study aims to explore the feasibility of a newly developed theory-based inclusive art participation program for promoting psychosocial health of people with physical disabilities living in residential care homes. Specifically, the feasibility is assessed following the framework proposed by Bowen et al. (2009), which encompassed five aspects, including demand, implementation, practicality, preliminary effects, and acceptability. As for the preliminary effects, this project will evaluate self-esteem, sense of control, self-efficacy, mood, and social connectedness after the completion of program. This study will adopt a one group pretest-posttest approach with quasi-experimental design to collect both quantitative and qualitative data, employing a mixed-methods study design.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 20, 2026

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 31, 2025

Last Update Submit

January 10, 2026

Conditions

Keywords

ArtResidential care homeFeasibilityMixed-methods

Outcome Measures

Primary Outcomes (5)

  • Preliminary effects - Sense of control

    The Chinese version of Recovery Locus of Control Scale (RLOCS) 9-item will be adopted to assess sense of control. Each item is rated on a five-point scale from 1='strongly agree' to 5='strongly disagree'. The total score ranged from 9 to 45. A higher total score indicates a better sense of control.

    From enrollment to the end of treatment at 6 weeks.

  • Preliminary effects - Self-esteem

    The Chinese version of Rosenberg Self-Esteem Scale - 10-item (RSES) will be adopted to measure self-esteem. It consists of five positively worded items and five negatively worded items. Each item is rated on a four-point scale. Specifically, positively worded items are given a score from 1='strongly agree' to 4='strongly disagree', while negatively worded are reverse scored, from 1='strongly disagree' to 4='strongly agree'. The total score is summed up to give a range from 10 to 40. A higher score represents greater self-esteem.

    From enrollment to the end of treatment at 6 weeks.

  • Preliminary effects - Self-efficacy

    The Chinese version of General Self-Efficacy Scale (GSES) 10-item will be used to measure 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 up to give a range from 10 to 40. A higher score represents greater general self-efficacy.

    From enrollment to the end of treatment at 6 weeks.

  • Preliminary effects - Mood

    The Chinese version of Positive and Negative Affect Scale (PANAS) will be used to evaluate mood. It is a 20-item self-report questionnaire that measures mood by assessing the experience of positive and negative emotions, which are 10 items for positive emotions and other 10 items for negative emotions. Each item is rated on a five-point scale from 1=' very slightly or not at all' to 5='extremely'. The total scores range from 10 to 50 for positive and negative mood, respectively. A higher score of positive domain indicates higher levels of positive affect, while a lower score of negative domain represents lower levels of negative affect.

    From enrollment to the end of treatment at 6 weeks.

  • Preliminary effects - Social connectedness

    The Chinese version of Social Connectedness Scale - Revised - 20-item (SCS-R) to assess social connectedness. Each item is rated on a six-point scale from 1='strongly disagree' to 6='strongly agree'. The total score is summed up to give a range from 20 to 120. A higher score indicates more connectedness to others.

    From enrollment to the end of treatment at 6 weeks.

Other Outcomes (4)

  • Demand

    From enrollment to the end of treatment at 6 weeks.

  • Practicality

    From enrollment to the end of treatment at 6 weeks.

  • Implementation

    From enrollment to the end of treatment at 6 weeks.

  • +1 more other outcomes

Study Arms (1)

Art intervention

EXPERIMENTAL
Other: Inclusive art program

Interventions

The inclusive art participation program will consist of a six-weekly session syllabus of 90 minutes per session. It will be led by a nurse facilitator who has been trained in using art as a healing tool in the healthcare context. Group format of four to six participants per group will be adopted. It will be conducted in a private and active room at residential care homes, which offers a comfortable space that enables participants to express themselves in a safe and confidential environment. The program will focus not only on promoting psychosocial health but also emphasize the inclusive and supportive environment to contribute to social interaction and engagement in meaningful social activities, that affirm the rights of people with physical disabilities living in residential settings.

Art intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years old or above
  • have single or multiple physical disabilities caused by disease, accident, or aging, characterized by long-term impairments in mobility, stamina, or dexterity
  • reside in residential care home
  • only have a mild cognitive impairment defined as having a Montreal Cognitive Assessment (MoCA) score which fall above the 16th percentile
  • have upper limb function with below a score of 50 assessed by Quick Disability of the Arm, Shoulder and Hand (DASH) Questionnaire
  • able to remain in sitting position independently
  • able to understand and communicate with Chinese, and (8) able to read Traditional Chinese.

You may not qualify if:

  • individuals with severely impaired speaking, hearing, or visual acuity
  • individuals have physical unwell for participating in this study
  • individuals are currently taking part in other research projects or receiving other programs for promoting psychosocial health

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mimi Wai Man Chan, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 20, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

January 20, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share