Expressive Arts-based Intervention for Adults With Age-related Visual Impairment

NCT05675150 | Recruiting

• 1 other identifier: 17611122
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Age-related Macular Degeneration (AMD) is an age-related eye disease resulting in vision loss. Persons with AMD not only experience a gradual loss of ability in independent living, but also profound impairment in psychosocial well-being.The multimodal, expressive arts-based intervention (EXABI) that emphasizes imagination and creativity can be an engaging, enjoyable, and safe process of empowerment. This study aims to investigate the effectiveness and process of an expressive arts-based intervention in enhancing psychosocial wellness and adjustment to gradual vision loss of persons with AMD. This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group.

Conditions

Age-Related Macular Degeneration

Keywords

Age-related visual impairment; Psychosocial wellbeing; Expressive arts-based intervention; Macular degeneration; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Change of Baseline Psychosocial Adaptation Questionnaire for visual impairment level at 2 months, 5 months, and 8 months

  Administration of the Chinese translated version of the 38-item Psychosocial Adaptation Questionnaire: * The first factor was attitude, involving 10 items. The second factor was self-acceptance, involving six items. The third factor was self-esteem involving six items. The fourth factor was anxiety/depression, involving six items. The fifth factor was belonging, involving five items. The sixth factor was self-efficacy involving three items. The last factor was the sense of self-control, involving two items. * Higher scores indicate a higher level of endorsement in a specific domain. * Likert's scale with four points was used to quantify results. The four points included completely incorrect, more correct, most correct, and completely correct. The score for positive items was one point, two points, three points, and four points; negative items were scored oppositely. * Q14, Q17, Q19, Q20, Q21, Q22, Q29, Q30, Q31, and Q32 are reversed (positive) items.

  Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8)

• Change of Baseline Vision-related Quality of Life level at 2 months, 5 months, and 8 months

  Administration of the Chinese translated version of the 13-item Vision-related Quality of Life Scale: * Vision-specific quality of life is measured by the 13-item Vision-Related Quality of Life Scale taken from 25-item National Eye Institute Visual Function Questionnaire. * Social functioning of Vision-specific quality of life is Q11 and Q13 respectively. * Mental health of Vision-specific quality of life is Q3, Q25, Q21, and Q22 respectively. * Role limitation of Vision-specific quality of life is Q17 and Q18 respectively. * Dependency of Vision-specific quality of life is Q20, Q23, and Q24 respectively. * Ocular pain of Vision-specific quality of life is Q4 and Q19 respectively. * Original numeric values from the survey are re-coded following the scoring rules. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 1

  Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8)

Secondary Outcomes (6)

• Change of Baseline Anxiety level at 2 months, 5 months, and 8 months

  Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8)

• Change of Baseline Depression level at 2 months, 5 months, and 8 months

  Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8)

• Change of Baseline Resilience level at 2 months, 5 months and 8 months

  Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8)

• Change of Baseline Perceived Social Support level at 2 months, 5 months and 8 months

  Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8)

• Change of Baseline Imagination level at 2 months, 5 months, and 8 months

  Baseline, post-intervention (Month 2), 3-month after post-intervention (Month 5), and 6-month after post-intervention (Month 8)

Study Arms (2)

Intervention

EXPERIMENTAL

This arm of participants will be receiving expressive arts-based intervention as intervention

Behavioral: Expressive Arts-Based Intervention

Wait-list control

NO INTERVENTION

This arm of participants will not receive any art-based intervention during the study and are allocated as a wait-list control group

Interventions

Expressive Arts-Based Intervention BEHAVIORAL

The intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflection and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in intervention may seek meaning, clarity, insight and healing.

Intervention

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are community-dwelling, Chinese-speaking adults aged between 50 and 80, with the diagnosis of age-related macular degeneration in one or both eyes of all different etiologies

You may not qualify if:

• Inability to understand the Chinese language, as well as a diagnosis of total blindness, presence of other significant physical, psychological, and cognitive comorbidities that would hinder the participant from completing the study will be excluded.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator
• The Hong Kong Society for the Blind: collaborator

Study Sites (1)

Centre on Behavioral Health, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Ho RTH, Cheong AMY, Wan AHY, Lo TLT, Fong TCT, Chan CKP, Li Q, Chan WC. Protocol for a mixed-methods randomised controlled trial evaluating the psychosocial effects of an expressive arts-based intervention on adults with age-related macular degeneration. BMJ Open. 2024 Dec 20;14(12):e088311. doi: 10.1136/bmjopen-2024-088311.

  PMID: 39806623 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Rainbow Ho

  Director/Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rainbow Ho

CONTACT

(852)28315158; tinho@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of this trial, neither the staff, participants nor care provider can be masked to allocation. The data analyst will be blinded after study completion by having the intervention group information coded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Randomized Controlled Trial

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 9, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 3 years after the completion of the study
• Access Criteria: The principal investigator will evaluate each request to determine if the data is accessible to other researchers.

Locations

HK (1)