Impact of an Educational Video on Satisfaction After Glaucoma Surgery

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03958929
• Other study ID #: 2019-074-K-73
• Status: Suspended
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 264
• Est. completion date: January 30, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.

Locations

Country	Name	City	State
China	Affiliated Eye Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

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