Age-Related Macular Degeneration Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05984927 -
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05536297 -
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
|
Phase 3 | |
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Completed |
NCT04005352 -
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
|
Phase 3 | |
Withdrawn |
NCT02873351 -
A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration
|
Phase 2 | |
Active, not recruiting |
NCT02802657 -
Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration
|
Phase 4 | |
Not yet recruiting |
NCT02864472 -
Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose
|
Phase 4 | |
Recruiting |
NCT01521065 -
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT02035722 -
Intravitreal Injections-related Anxiety
|
Phase 2/Phase 3 | |
Completed |
NCT01445548 -
Sirolimus for Advanced Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT01175395 -
20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01048476 -
Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01174407 -
Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration
|
N/A | |
Terminated |
NCT00712491 -
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT00345176 -
Age-Related Eye Disease Study 2 (AREDS2)
|
Phase 3 | |
Completed |
NCT02140151 -
Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT02555306 -
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Recruiting |
NCT04796545 -
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
|
N/A | |
Completed |
NCT03166202 -
Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
|
||
Completed |
NCT01397409 -
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
|
Phase 2 |