Clinical trial NCT02629237: Satisfaction After Glaucoma Surgery in Rural China
Official title: Impact of Multifaceted Education on Satisfaction After Glaucoma Surgery in Rural China
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma surgery
educational intervention
satisfaction
rural
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 0
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: 1. Investigate degree of postoperative satisfaction in county level hospital glaucoma patients.
2. Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients.
3. Investigate the effect factors of postoperative 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 score over three follow-up visits
timeFrame: 1 week, 2 week and 4 week after surgery.
Secondary outcomes:
measure: The rate of willingness to recommend surgery to a friend or relative with glaucoma
timeFrame: 1 week, 2 week and 4 week after surgery.
measure: Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality
timeFrame: before surgery
measure: Knowledge scores about glaucoma
timeFrame: before surgery and 1 week, 2 week and 4 week after surgery
measure: Intraocular pressure in both groups
timeFrame: before surgery and 1 week, 2 week and 4 week after surgery
measure: visual acuity in both groups
timeFrame: before surgery and 1 week, 2 week and 4 week after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Blindness Preventment and Treatment Department
state: Guangdong
Study officials:
affiliation: The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University
name: Nathan Congdon, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: