Impact of Decision Aids on Bariatric Surgery Choice: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Decisional conflict
研究概览
简要总结
Sleeve gastrectomy, Roux-en-Y gastric bypass, laparoscopic gastric banding, and bioenteric intragastric balloon insertion are common types of bariatric surgeries. These treatment strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical complications, and life quality improvement. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. Investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on obese patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and knowledge improvement. Investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity
- •Body mass index (BMI) ≧ 37 kg / m2
排除标准
- •Endocrine system abnormalities in patients
- •Drug abuse or mental illness
- •Major organ dysfunction and can accept surgery
- •Patients cannot understand Chinese
- •Age less than 20 years old or more than 70 years old
结局指标
主要结局
Decisional conflict
时间窗: One week after intervention
Total scores of decisional conflict scale
次要结局
- Decision regret(3 month after bariatric surgery)
研究者
SU YEN-HAO
Director of Metabolic and Weight Management Center
Taipei Medical University Shuang Ho Hospital
