Satisfaction After Glaucoma Surgery in Rural China

Study Overview
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Brief Summary
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Investigate degree of postoperative satisfaction in county level hospital glaucoma patients. Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients. Investigate the effect factors of postoperative satisfaction.

Detailed Description
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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.

Official Title
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Impact of Multifaceted Education on Satisfaction After Glaucoma Surgery in Rural China

Conditions
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Glaucoma

Intervention / Treatment
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* Other: Multifaceted education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifaceted education group<br>Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery. | Other: Multifaceted education<br>* Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.<br>|
| No Intervention: control group<br>Subjects will not be asked to watch education film and not participate in counseling session before and after surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean satisfaction score over three follow-up visits | The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at three follow-up visits: 1 week, 2 week and 4 week after surgery and dividing the total by the number of scores. The satisfaction score was 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 week, 2 week and 4 week after surgery. | 

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 week, 2 week and 4 week after surgery. | 
| Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality |  | before surgery | 
| Knowledge scores about glaucoma |  | before surgery and 1 week, 2 week and 4 week after surgery | 
| Intraocular pressure in both groups | Unit of Intraocular pressure is mmHg. | before surgery and 1 week, 2 week and 4 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) | before surgery and 1 week, 2 week and 4 week after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma surgery, educational intervention, satisfaction, rural