跳至主要内容
临床试验/NCT02492191
NCT02492191已完成不适用

RAPP- Systematic E-assessment of Postoperative Recovery in Patients Undergoing Day Surgery

Örebro University, Sweden2 个研究点 分布在 1 个国家目标入组 1,046 人开始时间: 2015年10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
1,046
试验地点
2
主要终点
Cost effectiveness

研究概览

简要总结

Introduction Day surgery is a well-established practice in many European countries, but only limited information is available regarding postoperative recovery at home though there is a current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is also a need for improvement of modern technology in assessing patient related outcomes such as native software applications. This article describes the RAPP study protocol, a mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing day surgery is cost effective and improves postoperative recovery, health and quality of life.

Methods and analysis This study is a mixed-methods study design that includes a multicenter, two-group, parallel, single-blind randomized controlled trial (RCT) and qualitative interview studies. One thousand patients >17 years of age who are undergoing day surgery will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR) or to standard care (i.e. no follow up). The primary aim is cost effectiveness. Secondary aims are improvements on postoperative recovery, health-related quality of life (QoL) and overall health; (b) to determine whether differences in health literacy have a substantial and distinct effect on postoperative recovery, health, and QoL; and (c) to describe day-care patient and staff experiences with a systematic e-assessment follow-up after day surgery.The primary will be measured at 2 weeks postoperatively and secondary outcomes b) at 1 and 2 weeks and c) at 1 and 4 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Understand the Swedish language in speech and writing, have an Android or iPhone OS smartphone, and give their informed consent to participate

排除标准

  • Undergoing abortion, if their journal entries indicate alcohol and/or drug abuse or memory impairment, if they are participating in another clinical trial or suffering from visual impairment. .

结局指标

主要结局

Cost effectiveness

时间窗: 14 days postoperatively

The analysis of cost effectiveness will consider the costs associated with the follow-up, gained QALYs from SF-6D. The SF-6D provides a means for using the SF-36 by estimating a preference-based single-index measure for health from these data using general population values. This analysis will be complemented with information regarding the individuals' willingness to pay for the follow-up, number of healthcare contacts, and duration and degree of sick leave.

次要结局

  • Postoperative recovery(7 and 14 days postoperatively)
  • Quality of Life (QoL)(Preoperatively(baseline) and 14 days postoperatively)
  • Overall health(Preoperatively(baseline) and 14 days postoperatively)
  • Health literacy(14 days postoperatively)
  • Patient experience of the intervention(1 month postopertively)
  • Staff experience of the implementation(4 months postoperatively)

研究者

发起方
Örebro University, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulrica Nilsson

Professor

Örebro University, Sweden

研究点 (2)

Loading locations...

相似试验