跳至主要内容
临床试验/NCT02256202
NCT02256202已完成不适用

Pilot Study of Quality Assurance in Interventional Pain Therapy in the Lumbal Spinal Column. Non-randomised, Evaluative, Multicentral Study Concerning the Applicability of a Tablet-PC.

Qualitouch-HC Foundation1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Feasibility of Tablet-PC in interviewing pain patients

研究概览

简要总结

There are actually no standardized quality assurance procedures included in pain treatment processes.

In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested in pain therapy centres using the validated questionnaire "Activity Index". The acceptance of electronic data capturing is tested in patients and therapy teams (doctors and nurses).

详细描述

Regarding the demand for a duly documented efficacy of the therapy applied, a standardized procedure is imperative to show the medical and economic advantages of a given therapy. To obtain valid results, it is necessary to use a standardized process, monitored with a validated questionnaire.

In this multi-center study the Activity Index Questionnaire will be tested regarding its outcome quality regarding usability and patient acceptance. Each center collects data of 10 patients with injection pain therapy. Each patient is interviewed twice and after the 2nd interview each patient will fill out a feasibility questionnaire. During the whole study, the use and consumption of oral analgetic drugs are monitored in a diary. The statistical Analysis is done descriptive. Before entering the study, each patient has to give informed consent to participate. National Registration Guidelines for post market surveillance will be obtained.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Willingness for therapeutic pain injection in lumbar spine

排除标准

  • Cognitive impairment, technical Problems in interviewing patients

结局指标

主要结局

Feasibility of Tablet-PC in interviewing pain patients

时间窗: 6-12 months

The feasibility of the Tablet-PC in EDC will be assessed by standardized interviews (three times) of the study doctor, the study nurse and the patient.

次要结局

  • Problems in application of EDC in Tablet-PC(12 months)

研究者

发起方
Qualitouch-HC Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验