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临床试验/NCT04301128
NCT04301128已完成不适用

Research Asistant in Deparment of Nursing

Eskisehir Osmangazi University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年12月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
subcutaneous anti TNF-α drug administration was assesed by "Subcutaneous Anti-TNF Treatment Questionnaire "

研究概览

简要总结

This study was carried out to develop an android mobile application for the subcutaneous (SC) anti-TNF drug administration of ankylosing spondylitis patients and to evaluate its effect on drug administration.

The universe of this experimental designed posttest control group research is consisted of patients prescribed subcutaneous anti-TNF drug due to ankylosing spondylitis in Eskişehir Osmangazi University Health, Application and Research Hospital Rheumatology Polyclinic between 15 December 2017 - 30 December 2019. The patients who constituted the sample of the study were assigned by lot to mobile application and the education booklet groups. The mobile application that includes follow-up and information related to disease information, anti-TNF drug application and management was transferred to mobile phones of patients in mobile application group via bluetooth technology and installed. The patients in the education booklet group were given an education booklet on disease information, antiTNF drug administration and management. In the study, patients were evaluated once before anti-TNF drug treatment and every 6 weeks during 6 months (4 times) after treatment. The data of the study were collected by means of an individual identification form, BASDAI, BASFI, ASQoL and Subcutaneous Anti-TNF Treatment Questionnaire .

详细描述

Ankylosing spondylitis is a chronic, inflammatory disease that affects the axial spine, causing progressive limitation on the spine and leading to a decrease in quality of life. Anti TNF drugs are frequently used in the treatment of ankylosing spondylitis and teaching activities in improving patient compliance and patient compliance are very important in the success of this treatment. This study was carried out to develop an android mobile application for the subcutaneous (SC) anti-TNF drug administration of ankylosing spondylitis patients and to evaluate its effect on drug administration.

The universe of this experimental designed posttest control group research is consisted of patients prescribed subcutaneous anti-TNF drug due to ankylosing spondylitis in Eskişehir Osmangazi University Health, Application and Research Hospital Rheumatology Polyclinic between 15 December 2017 - 30 December 2019. The patients who constituted the sample of the study were assigned by lot to mobile application and the education booklet groups. The mobile application that includes follow-up and information related to disease information, anti-TNF drug application and management was transferred to mobile phones of patients in mobile application group via bluetooth technology and installed. The patients in the education booklet group were given an education booklet on disease information, antiTNF drug administration and management. In the study, patients were evaluated once before anti-TNF drug treatment and every 6 weeks during 6 months (4 times) after treatment. The data of the study were collected by means of an individual identification form, BASDAI, BASFI, ASQoL and Subcutaneous Anti-TNF Treatment Questionnaire.

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
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

  • •are diagnosed with ankylosing spondylitis according to the New York modification criterias
  • •administer anti-TNF agent for the first or second time
  • •are 18 years old and had literacy
  • •have an android phone,
  • •can use the andriod phone,
  • •agree to participate in the work

排除标准

  • •refuse to participate in the study
  • •be young than 18 years old
  • •administer anti-TNF agent more than twice

研究组 & 干预措施

EXPERIMENTAL GROUP

Experimental

Patients in the experimental group were able to install and set up mobile application on android phones via Bluetooth and were informed about the sick android application. Patients were reminded and guided by subcutaneous anti-TNF drug treatments from mobile application. Both groups of patients were then assessed using face-to-face interviews for 6 months, 6 weeks after using the Subcutaneous Anti-TNF Treatment Questionnaire , BASDAI, ASQoL, BASFI scales.

干预措施: Experimental (Other)

BOOKLET GROUP

Active Comparator

An anti-TNF drug administration training booklet were given to patients in the control group and were required to take advantage of the booklet on subcutaneous anti-TNF drug production. Both groups of patients were then assessed using face-to-face interviews for 6 months, 6 weeks after using the Subcutaneous Anti-TNF Treatment Questionnaire , BASDAI, ASQoL, BASFI scales. At the end of the study (twenty forth week) was applied to all patients.

干预措施: control (Other)

结局指标

主要结局

subcutaneous anti TNF-α drug administration was assesed by "Subcutaneous Anti-TNF Treatment Questionnaire "

时间窗: 4 times in 6 months

In this questionnaire, It is expected from patients to answer "no" or "I always administered it myself" to these questions: "How often was your medication administered by someone else?", "In the last 6 weeks, did you ever miss or forget your dose of medication?" and "Did you ever skip implementing your medication dose thinking that your illness is under control?" Furthermore, the mean scores of "Overall difficulty level in continuing SC anti-TNF drug treatment" and "Satisfaction level with anti-TNF drug treatment in the last 6 weeks" are expected to be high.

次要结局

未报告次要终点

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fusun Uzgor

Research Assistant

Eskisehir Osmangazi University

研究点 (1)

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