Impact of an Educational Video on Satisfaction After Glaucoma Surgery
Primary Purpose
Glaucoma
Status
Suspended
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Educational Video
Sponsored by

About this trial
This is an interventional health services research trial for Glaucoma focused on measuring glaucoma surgery, educational intervention, satisfaction, rural
Eligibility Criteria
Inclusion Criteria:
- age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy
Exclusion Criteria:
- patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
Sites / Locations
- Affiliated Eye Hospital of Nanchang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Education group
Control group
Arm Description
Subjects will be asked to watch a 5-10 min education film two times (pre-op one day and post-op one day).
Standard patient procedure that includes a pre-operative discussion with an ophthalmologist about glaucoma surgery, during which the surgeon gains the patient's informed consent. Subjects will not be asked to watch education film..
Outcomes
Primary Outcome Measures
The mean satisfaction outcome over two follow-up visits
The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at two follow-up visits: 1 day and 1 week after surgery and dividing the total by the number of scores. The satisfaction score will be assessed as a cumulative score.
Composite outcome, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency, although such measure may prove challenging for the interpretation of results. (Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003; 289: 2554-2559)
Secondary Outcome Measures
The rate of willingness to recommend surgery to a friend or relative with glaucoma
The measurement method: questionnaire
Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality
The measurement method: questionnaire. The questionnaire provides subscores for 5 categories (Short, Extraversion, Neuroticism, Psychoticism, Lie score), with a higher corresponding to a higher characterization of that particular trait.
Knowledge scores about glaucoma
The measurement method: questionnaire.
Mean knowledge scores is calculated by adding up the scores at two follow-up visits: 1 day and 1 week after surgery and dividing the total by the number of scores. Knowledge scores will be assessed as a cumulative score, and will be compared with the baseline pre-operative score.
Intraocular pressure in both groups
Unit of Intraocular pressure is mmHg.
visual acuity in both groups
Visual acuity testing use Snellen-based letter charts,such as a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is 0.3)
Full Information
NCT ID
NCT03958929
First Posted
May 20, 2019
Last Updated
April 11, 2023
Sponsor
Sun Yat-sen University
Collaborators
Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03958929
Brief Title
Impact of an Educational Video on Satisfaction After Glaucoma Surgery
Official Title
A Randomized Controlled Trial on the Impact of an Educational Video on Satisfaction After Glaucoma Surgery in Urban and Rural China
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
change study sites
Study Start Date
October 10, 2023 (Anticipated)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Overall Objective: This study will assess whether an educational video is effective in increasing patient satisfaction with glaucoma surgery.
Investigate the impact of educational interventions on glaucoma patients' surgical satisfaction.
Investigate the post-operative satisfaction of rural glaucoma patients in county hospitals
Investigate the difference in postoperative satisfaction between urban and rural glaucoma patients in urban hospitals
Investigate other factors that influence postoperative glaucoma satisfaction.
Detailed Description
Glaucoma is the leading cause of irreversible blindness in China, as elsewhere in the world. In Chinese rural settings, where topical glaucoma medication is unlikely to be a practical and sustainable option, surgery is the primary treatment modality for glaucoma.
However, it is known that vision is quite likely to decline in the short to medium term after glaucoma surgery, and there are concerns that dis-satisfaction resulting from such vision changes might lead to negative social marketing, affecting uptake not only of glaucoma surgical care but other eye operations (principally cataract) as well. We propose to test the impact on post-operative satisfaction of a multi-media educational intervention designed to give patients a realistic expectation of their post operative course: glaucoma surgery is being performed NOT to improve vision, but do protect it from future harm, and vision may in fact decline for several weeks post operatively.
A randomized controlled design will be used, and subjects undergoing glaucoma surgery will be enrolled at 4 rural county hospitals in rural Guangdong province, and randomized to receive the intervention or usual care. The principal outcome will be subjective satisfaction on a previously-tested questionnaire instrument, administered pre-operatively and post-operatively on two occasions in the first month following surgery. Patients not returning post-operatively to the surgical facility will be contacted by telephone for administration of the questionnaire. Other facility- and patient-related clinical and personal factors expected to influence satisfaction will also be recorded, and adjusted for in all analyses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma surgery, educational intervention, satisfaction, rural
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education group
Arm Type
Experimental
Arm Description
Subjects will be asked to watch a 5-10 min education film two times (pre-op one day and post-op one day).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard patient procedure that includes a pre-operative discussion with an ophthalmologist about glaucoma surgery, during which the surgeon gains the patient's informed consent. Subjects will not be asked to watch education film..
Intervention Type
Other
Intervention Name(s)
Educational Video
Intervention Description
The film follows the journey of an elderly patient scheduled to undergo glaucoma surgery, beginning with a face-to-face Q&A health session with an eye doctor. After surgery, the patient talks about his post-operative eyesight and discusses the benefits of early diagnosis and glaucoma surgery for treatment with his community.
Primary Outcome Measure Information:
Title
The mean satisfaction outcome over two follow-up visits
Description
The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at two follow-up visits: 1 day and 1 week after surgery and dividing the total by the number of scores. The satisfaction score will be assessed as a cumulative score.
Composite outcome, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency, although such measure may prove challenging for the interpretation of results. (Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003; 289: 2554-2559)
Time Frame
1 day, 1 week
Secondary Outcome Measure Information:
Title
The rate of willingness to recommend surgery to a friend or relative with glaucoma
Description
The measurement method: questionnaire
Time Frame
1 day, 1 week
Title
Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality
Description
The measurement method: questionnaire. The questionnaire provides subscores for 5 categories (Short, Extraversion, Neuroticism, Psychoticism, Lie score), with a higher corresponding to a higher characterization of that particular trait.
Time Frame
Baseline (before surgery)
Title
Knowledge scores about glaucoma
Description
The measurement method: questionnaire.
Mean knowledge scores is calculated by adding up the scores at two follow-up visits: 1 day and 1 week after surgery and dividing the total by the number of scores. Knowledge scores will be assessed as a cumulative score, and will be compared with the baseline pre-operative score.
Time Frame
Baseline (before surgery); 1 day and 1 week after surgery
Title
Intraocular pressure in both groups
Description
Unit of Intraocular pressure is mmHg.
Time Frame
Baseline (before surgery); 1 day and 1 week after surgery
Title
visual acuity in both groups
Description
Visual acuity testing use Snellen-based letter charts,such as a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is 0.3)
Time Frame
Baseline (before surgery); 1 day and 1 week after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy
Exclusion Criteria:
patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Congdon, MD,MPH
Organizational Affiliation
The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuanbo Liang, MD, PhD
Organizational Affiliation
The Eye Hospital, Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Eye Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of an Educational Video on Satisfaction After Glaucoma Surgery
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