Patient-centered Decision Support Tool for Levothyroxine Dosage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Number of patients at biochemical target
研究概览
简要总结
Levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. Because dosage adjustment normally takes several months, the investigators have developed a decision support tool (DST) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. In this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. The use of DST to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. The effect of DST use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at Norwegian hospitals
排除标准
- •Anaplastic thyroid cancer, thyroid cancer with distant metastasis, graves disease, toxic nodules, pregnancy
结局指标
主要结局
Number of patients at biochemical target
时间窗: Outcome is measured at 8 weeks, 6 months and 12 months post surgery
Number of patients at biochemical target. Biochemical target is TSH (thyroid stimulating hormone) 0,5-2,0 mIE/L for patients on substitution therapy and 0,1-0,5 mIE/L for patients on suppression therapy
次要结局
- Time to biochemical target(Measured at 18 months after surgery)
- Distance from biochemical target(Measured at 8 weeks post surgery)
- Patient reported outcome - ThyPRO39 questionnaire(Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery)
- Patient reported outcome - RAND-36 questionnaire(Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery)
- Abscence from work(Measured at18 months after surgery)
研究者
Vegard Brun
Consultant physician and associate professor
University Hospital of North Norway