Back to resultsIntravitreal Injections-related Anxiety
Primary Purpose
Age-related Macular Degeneration
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Printed materials
Video
Sponsored by
About this trial
This is an interventional prevention trial for Age-related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- 18 years and older
- AMD patients requiring intravitreal injections
Exclusion Criteria:
- Unable to read or comprehend English
- Any contraindications to intravitreal injections, such as IOP elevations
Sites / Locations
- Toronto Western Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control group
Video materials
Print materials
Arm Description
AMD-related information is not given to patients randomized to the control group.
Educational materials are presented in through a video (audio and visual)
Educational materials are presented in the format of printed brochure (visual)
Outcomes
Primary Outcome Measures
Anxiety
Secondary Outcome Measures
Knowledge of AMD
Full Information
NCT ID
NCT02035722
First Posted
January 10, 2014
Last Updated
February 20, 2015
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02035722
Brief Title
Intravitreal Injections-related Anxiety
Official Title
A Visual Approach to Reducing Anxiety and Improving Knowledge Transfer for Patients Receiving Intravitreal Injections
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The use of intravitreal injections of Ranibizumab (Lucentis, Genentech) is becoming increasing common for the management of age-related macular degeneration (AMD). It is therefore important to acknowledge and address patients' anxiety due to anticipated discomfort from the idea of "getting a needle in the eye". In addition, visual provision of information at diagnosis concerning long-term treatment expectation may enhance the informed consent process. The use of visual aids may also accommodate patients of different educational background when presented with new and complex treatment information. 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. Although this tool will be developed in the context of injection-requiring retinal diseases, it has applications in the care of disease requiring long-term treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
AMD-related information is not given to patients randomized to the control group.
Arm Title
Video materials
Arm Type
Active Comparator
Arm Description
Educational materials are presented in through a video (audio and visual)
Arm Title
Print materials
Arm Type
Active Comparator
Arm Description
Educational materials are presented in the format of printed brochure (visual)
Intervention Type
Behavioral
Intervention Name(s)
Printed materials
Intervention Description
AMD-related information is presented to patients in the form of a brochure (i.e. printed materials)
Intervention Type
Behavioral
Intervention Name(s)
Video
Intervention Description
AMD-related information is presented as in the form of a video
Primary Outcome Measure Information:
Title
Anxiety
Time Frame
Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.
Secondary Outcome Measure Information:
Title
Knowledge of AMD
Time Frame
Cross-sectional study, where questionnaires will be completed on the same day of clinic visit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years and older
AMD patients requiring intravitreal injections
Exclusion Criteria:
Unable to read or comprehend English
Any contraindications to intravitreal injections, such as IOP elevations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai-Ching Lam
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Injections-related Anxiety
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