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临床试验/CTRI/2024/02/063212
CTRI/2024/02/063212尚未招募3 期

Patient supported care model: Pilot study of a mobile application based tool to increase compliance in patients with chronic kidney disease

Sanja Sameer Behera1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Primary Outcome

研究概览

简要总结

A number of mobile applications are available which primarily serve to remind the patient about his prescribed medications. However, none of these is designed to ascertain the causes of non-compliance. We plan to use the basic workflow of such mobile applications and design a new mobile application with following features:

1.     Both the treating physician or supporting healthcare staff and patient will be users of the system.

2.     Patients will be able to enter the details of procured/bought/received medications in the application. These details will include name, dose and frequency. They will also note duration (in days) of the prescribed treatment.

3.     Physicians will be able to track the details of compliance and reasons for non-compliance, if recorded by the patient.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All patients with CKD stage G3-4 (defined as per KDIGO CKD guidelines) who will be attending the outpatient clinic in the Department of Nephrology at PGIMER with Clinically stable status for last 3 months as judged by treating physician and having Access to a smartphone that can run the mobile application.

排除标准

  • All patients with CKD stage G3-4 (defined as per KDIGO CKD guidelines) who will be attending the outpatient clinic in the Department of Nephrology at PGIMER with
  • Poor functional status as judged by treating physician
  • Present or past diagnosis of malignancy
  • Pregnancy or lactation in case of females
  • Organ transplant recipient
  • Previous diagnosis of any psychiatric illness or illicit drug abuse.

结局指标

主要结局

Primary Outcome

时间窗: 03 months

1. Difference in compliance (C) with prescribed treatment between groups

时间窗: 03 months

次要结局

  • 1. Reasons for non-compliance in the study population(2. Proportion of patients who do not use mobile application for ≥15 days over 3 months in the intervention group and reasons for the same)

研究者

发起方
Sanja Sameer Behera
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sanja Sameer Behera

Post Graduate institute of Medical Education and Research, Chandigarh

研究点 (1)

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