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Age-Related Macular DegenerationNCT05675150

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

A study testing Expressive Arts-Based Intervention in people with Age-Related Macular Degeneration, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
Expressive Arts-Based Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteHong Kong
Study dates
1 May 2023to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rainbow Ho contact

(852)28315158

tinho@hku.hk

Hong Kong1 site, 1 recruiting
  • Centre on Behavioral Health, The University of Hong Kong

    Hong Kong

    Adrian Ho Yin Wan, (852) 28315158, awan@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Unlocking Limitations Through Arts: A Mixed Methods Study on the Effectiveness of an Expressive Arts-based Intervention on Psychosocial Wellbeing of Adults With Age-related Visual Impairment

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.

Read the detailed description

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. Given the impacts of irreversible visual loss, persons with AMD need to actively adapt to changes and renegotiate supportive relations to maintain well-being. Psychosocial enhancement may buffer against the deteriorating quality of life, psychological distress, and poor adjustments among adults with AMD. The multimodal, expressive arts-based intervention (EXABI) that emphasizes imagination and creativity can be an engaging, enjoyable, and safe process of empowerment. The EXABI could help bypass or expand the limit of vision during interaction, and broaden the coping repertoire of those with AMD.

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. Primary outcomes include psychosocial adaptation, and vision-related quality of life; and secondary outcomes including symptoms of depression and anxiety, resilience, social support, and imagination as well as associations between psychosocial variables, participants' experience in the group, and factors affecting the effectiveness of the EXABI will be explored.

This proposed study adopts a randomized controlled trial with mixed methods design. To address the research objectives, data collected will be triangulated and interpreted simultaneously to address the research questions. Outcome measures will be assessed on four time-points (T0: Pre-intervention at baseline; T1: Post-intervention; T2: 3-month post-intervention and; T3: 6-month post-intervention) to assess the immediate and sustained effects of the expressive arts-based intervention on psychosocial wellbeing of the participants. Qualitative interviews will be conducted with a random subsample of 30 participants from the expressive arts group at T1 and T3 to collect fine-grained, information to explore their overall experience of participation in the intervention and how the experience has shaped their coping experience in terms of stress management, self-care challenges, and to reestablish severed social connections. Results of the qualitative interviews will be used to enhance the interpretation and understanding of the quantitative findings.

Being tested
Expressive Arts-Based Intervention
Keywords
Age-related visual impairment, Psychosocial wellbeing, Expressive arts-based intervention, Macular degeneration, Randomized controlled trial
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expressive Arts-Based InterventionBehavioural

    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.

Study groups in NCT05675150
Study groupRoleWhat they receive
InterventionExperimentalThis arm of participants will be receiving expressive arts-based intervention as intervention
Receives: Behavioral: Expressive Arts-Based Intervention
Wait-list controlNo interventionThis arm of participants will not receive any art-based intervention during the study and are allocated as a wait-list control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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

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

Secondary outcomes (6)
  1. Change of Baseline Anxiety level at 2 months, 5 months, and 8 months

    Administration of the Chinese translated version of the Hospital Anxiety and Depression Scale.

    • This scale is adopted to measure the level of Anxiety.
    • The minimum score is 0 and the maximum score is 21.
    • Scores ranging from "0-7" represents "Normal", ranging from "8-10" represents "Borderline abnormal", and ranging from "11-21" represents "Abnormal".

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

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

    Administration of the Chinese translated version of the Hospital Anxiety and Depression Scale.

    • This scale is adopted to measure the level of Depression.
    • The minimum score is 0 and the maximum score is 21.
    • Scores ranging from "0-7" represents "Normal", ranging from "8-10" represents "Borderline abnormal", and ranging from "11-21" represents "Abnormal".

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

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

    Administration of the Chinese translated version of the self-report Resilience Scale-14.

    • The brief "RS-14 scale consists of 14 self-report items measured along a 7-point rating scale ranging from '1-strongly disagree' to '7-strongly agree.'
    • Higher scores are indicative of resilience level.
    • Scores are calculated by a summation of response values for each item, thus enabling scores to range from 14 to 98.
    • Scores below 65 indicate low resilience; between 65 and 81 show moderate resilience; above 81 will be interpreted as high levels of resilience.

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

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

    Administration of the Chinese version of the Multidimensional Scale of Perceived Social Support

    • This scale has adopted the measure the level of perceived social support from family, friends, or significant other.
    • The mean score of perceived social support from "family" is calculated by summing across Q3, Q4, Q8, and Q11, then divide by 4 values.
    • The mean score of perceived social support from "friends" is calculated by summing across Q6, Q7, Q9, and Q12, then divide by 4 values.
    • The mean score of perceived social support from "significant other" is calculated by summing across Q1, Q2, Q5, and Q10, then divide by 4 values.
    • The mean total score is calculated by summing across all 12 items, then divide by 12 values.
    • The minimum mean score of each sub-score and the total score is 1 and the maximum mean score is 7.

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

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

    Administration of the Chinese translated version of the Self-Descriptive Imagination questionnaire.

    • The Self-Descriptive Imagination Questionnaire consists of 25 items. Expressive imagination is Q4, Q5, Q12, Q7, and Q13 respectively. Openness to variations is Q16, Q19, Q17, and Q23 respectively. Instrumental imagination is Q8, Q11, and Q10 respectively. Past/future mindedness is Q2, and Q1 respectively. Conventionality is Q24 and Q25 respectively.
    • The questionnaires measured along a 7-point rating scale ranging from '1- strongly disagree' to '7-strongly agree.' Scores are calculated by a summation of response values for each item, Higher scores are indicative of imagination level.

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

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

    Administration of the Chinese translated version of the Fantastic Reality Ability Measurement.

    • The Fantastic Reality Ability Measurement consists of 21 items. Coping is Q4, Q8, Q15, and Q20 respectively. Transcendence is Q17, Q10, Q21, Q12, Q18, and Q7 respectively. Playfulness is Q5, Q6, Q9, Q14, Q19, and Q2 respectively. Control is Q11, Q13, Q3, Q16, and Q1 respectively.
    • The questionnaires measured along a 7-point rating scale ranging from '1- strongly disagree' to '7-strongly agree.' Scores are calculated by a summation of response values for each item, Higher scores are indicative of imagination level.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start1 May 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Randomized Controlled Trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05675150
Sponsor's protocol ID
17611122
Status last verified
May 2025
First submitted
2 Jan 2023
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data of this study are available from the principal investigator upon reasonable request. The data are not publicly available because they involve personal and clinical data from patients with age-related macular degeneration (AMD).

Publications

  • 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.

    PubMed 39806623

Questions about this trial

What is this clinical trial studying?

A study testing Expressive Arts-Based Intervention in people with Age-Related Macular Degeneration, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rainbow Ho ((852)28315158, tinho@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Baseline Psychosocial Adaptation Questionnaire for visual impairment level at 2 months, 5 months, and 8 months (time frame: Baseline, post-intervention (Month 2), 3-month post-intervention (Month 5), and 6-month post-intervention (Month 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05675150, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.

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