Intravitreal Injections-related Anxiety
A Visual Approach to Reducing Anxiety and Improving Knowledge Transfer for Patients Receiving Intravitreal Injections
1 other identifier
interventional
73
1 country
1
Brief Summary
Intravitreal injection of Ranibizumab (Lucentis, Genentech) is clinically indicated for patients with wet age-related macular degeneration (AMD) An disadvantage of this technique is the anxiety and discomfort which patients often experience due to the idea of "getting a needle in the eye". In addition, a recent case study indicated the importance of patient education in achieving positive outcomes from intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents. The purpose of our study is to determine whether visual education on AMD and intravitreal injection can reduce patients' anxiety prior to the treatment, and lessen the impact of socioeconomical status on their understanding of the treatment and prognosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 10, 2014
CompletedFirst Posted
Study publicly available on registry
January 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 24, 2015
February 1, 2015
2.6 years
January 10, 2014
February 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Anxiety
Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.
Secondary Outcomes (1)
Knowledge of AMD
Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.
Study Arms (3)
Control group
NO INTERVENTIONAMD-related information is not given to patients randomized to the control group.
Video materials
ACTIVE COMPARATOREducational materials are presented in through a video (audio and visual)
Print materials
ACTIVE COMPARATOREducational materials are presented in the format of printed brochure (visual)
Interventions
AMD-related information is presented to patients in the form of a brochure (i.e. printed materials)
Eligibility Criteria
You may qualify if:
- years and older
- AMD patients requiring intravitreal injections
You may not qualify if:
- Unable to read or comprehend English
- Any contraindications to intravitreal injections, such as IOP elevations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wai-Ching Lam
University Health Network, Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2014
First Posted
January 14, 2014
Study Start
September 1, 2011
Primary Completion
April 1, 2014
Study Completion
June 1, 2014
Last Updated
February 24, 2015
Record last verified: 2015-02