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临床试验/NCT04052750
NCT04052750Unknown不适用

Daily Short Message Service Reminders Increase Treatment Compliance and Efficacy in Outpatients With Functional Gastrointestinal Disorders: a Randomized Controlled Trial

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2019年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
176
试验地点
1
主要终点
Treatment compliance in outpatients with FGIDs

研究概览

简要总结

The effect of SMS follow-up on drug compliance and efficacy in patients with FGIDs has not been reported in the literature. We, therefore, conducted a prospective randomized controlled trial to investigate whether SMS follow-up could improve treatment adherence in patients with FGIDs, which in turn would help symptom relief and improve treatment outcomes.

详细描述

The irritable bowel syndrome (IBS) and other functional gastrointestinal disorders (FGIDs) are common and pose significant burdens to patients. Although regular medications have substantial benefits for disease remission, many patients do not follow the recommendations of standard medication regimens given by physicians at the time of the visit, so how to improve patient compliance becomes even more important. Many factors can affect drug compliance. Forgetting seems to be one of the important reasons for poor compliance. In order to solve this problem, many studies such as drug charts/calendars, mini kits, etc. have been conducted in previous studies. At present, with the popularization of mobile phones, SMS-based interventions are gradually being applied to various medical environments. Compared with the phone, SMS consumes less time and can be easily integrated into the patient's daily life. Therefore, short messages may be more suitable for follow-up of patients outside hospital.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with newly diagnosed FGIDs according to Rome-IV
  • Aged 18-70 years
  • With no obvious organic abnormalities

排除标准

  • With organic gastrointestinal diseases
  • With psychiatric diseases or are taking psychotropic agents
  • With severe cardiopulmonary or other organ diseases
  • Pregnant women

研究组 & 干预措施

The intervention group

Experimental

Patients in this group received a daily short message service (SMS) reminder when medications were prescribed

干预措施: SMS follow-up (Behavioral)

The control group

No Intervention

Patients in this group only received medications without daily text message reminder

结局指标

主要结局

Treatment compliance in outpatients with FGIDs

时间窗: week2

Compliance is assessed by the medication possession ratio (MPR). The MPR is often defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill. This calculation usually results in a ratio less than 1.0 if there are lapses in prescription refilling.

次要结局

  • Improvement of abdominal pain in outpatients with FGIDs(week2)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shengliang Chen

professor,chief physician

RenJi Hospital

研究点 (1)

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