Impact of an Educational Video on Satisfaction After Glaucoma Surgery

A Randomized Controlled Trial on the Impact of an Educational Video on Satisfaction After Glaucoma Surgery in Urban and Rural China

Overall Objective: This study will assess whether an educational video is effective in increasing patient satisfaction with glaucoma surgery.

1. Investigate the impact of educational interventions on glaucoma patients' surgical satisfaction.
2. Investigate the post-operative satisfaction of rural glaucoma patients in county hospitals
3. Investigate the difference in postoperative satisfaction between urban and rural glaucoma patients in urban hospitals
4. Investigate other factors that influence postoperative glaucoma satisfaction.

Study Overview

• Status: Suspended
• Conditions: Glaucoma
• Intervention / Treatment: Other: Educational Video

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.

• Study Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Affiliated Eye Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education group; Subjects will be asked to watch a 5-10 min education film two times (pre-op one day and post-op one day).	Other: Educational Video; 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.
No Intervention: Control group; 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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 day, 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of willingness to recommend surgery to a friend or relative with glaucoma	The measurement method: questionnaire	1 day, 1 week
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.	Baseline (before surgery)
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.	Baseline (before surgery); 1 day and 1 week after surgery
Intraocular pressure in both groups	Unit of Intraocular pressure is mmHg.	Baseline (before surgery); 1 day and 1 week after surgery
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)	Baseline (before surgery); 1 day and 1 week after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Wenzhou Medical University
• Investigators: Principal Investigator: Nathan Congdon, MD,MPH, The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University; Principal Investigator: Yuanbo Liang, MD, PhD, The Eye Hospital, Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 10, 2023
• Primary Completion (Anticipated): January 10, 2024
• Study Completion (Anticipated): January 30, 2024

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: satisfaction; rural; educational intervention; glaucoma surgery
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 2019-074-K-73

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No