Clinical trial NCT03958929: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma surgery
educational intervention
satisfaction
rural
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Wenzhou Medical University
First posted: 2019-05-22
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

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

Primary outcomes:
measure: The mean satisfaction outcome over two follow-up visits
timeFrame: 1 day, 1 week
Secondary outcomes:
measure: The rate of willingness to recommend surgery to a friend or relative with glaucoma
timeFrame: 1 day, 1 week
measure: Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality
timeFrame: Baseline (before surgery)
measure: Knowledge scores about glaucoma
timeFrame: Baseline (before surgery); 1 day and 1 week after surgery
measure: Intraocular pressure in both groups
timeFrame: Baseline (before surgery); 1 day and 1 week after surgery
measure: visual acuity in both groups
timeFrame: Baseline (before surgery); 1 day and 1 week after surgery
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Affiliated Eye Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University
name: Nathan Congdon, MD,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Eye Hospital, Wenzhou Medical University
name: Yuanbo Liang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: