Intravitreal Injections-related Anxiety

NCT ID: NCT02035722

Last Updated: 2015-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

AMD-related information is not given to patients randomized to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Video materials

Educational materials are presented in through a video (audio and visual)

Group Type ACTIVE_COMPARATOR

Video

Intervention Type BEHAVIORAL

AMD-related information is presented as in the form of a video

Print materials

Educational materials are presented in the format of printed brochure (visual)

Group Type ACTIVE_COMPARATOR

Printed materials

Intervention Type BEHAVIORAL

AMD-related information is presented to patients in the form of a brochure (i.e. printed materials)

Interventions

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Printed materials

AMD-related information is presented to patients in the form of a brochure (i.e. printed materials)

Intervention Type BEHAVIORAL

Video

AMD-related information is presented as in the form of a video

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wai-Ching Lam

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN-110463AE

Identifier Type: -

Identifier Source: org_study_id

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