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临床试验/NCT03578211
NCT03578211已完成不适用

Impact of Decision Aids on Bariatric Surgery Choice: A Randomized Controlled Trial

Taipei Medical University Shuang Ho Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年5月1日最近更新:
适应症

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

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

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

SU YEN-HAO

Director of Metabolic and Weight Management Center

Taipei Medical University Shuang Ho Hospital

研究点 (2)

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