Impact of Multifaceted Education on Satisfaction After Glaucoma Surgery in Rural China
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- The mean satisfaction score over three follow-up visits
研究概览
简要总结
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy
排除标准
- •patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
结局指标
主要结局
The mean satisfaction score over three follow-up visits
时间窗: 1 week, 2 week and 4 week after surgery.
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)
次要结局
- Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality(before surgery)
- visual acuity in both groups(before surgery and 1 week, 2 week and 4 week after surgery)
- Knowledge scores about glaucoma(before surgery and 1 week, 2 week and 4 week after surgery)
- Intraocular pressure in both groups(before surgery and 1 week, 2 week and 4 week after surgery)
- The rate of willingness to recommend surgery to a friend or relative with glaucoma(1 week, 2 week and 4 week after surgery.)
研究者
Congdon Nathan
vice directior,Blindness Prevention and Treatment Department
Sun Yat-sen University
