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临床试验/NCT05286944
NCT05286944Unknown不适用

Mobile Phone Daily Alarm To Improve Compliance Of Intranasal Corticosteroid Among Allergic Rhinitis Patients.

National University of Malaysia2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2020年1月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
207
试验地点
2
主要终点
Compliance

研究概览

简要总结

This is a randomized controlled trial to compare the compliance of allergic rhinitis patients towards intranasal steroids between those who use mobile daily alarm reminder and those who do not.

详细描述

In this single blinded RCT, adults with allergic rhinitis are randomized into either he intervention or control arm. The intervention involves installing an alarm with a prerecorded nmessage "Have you take your intranasal steroids" which will automatically ring every day on the patients mobile phone. The control arm do not have any alarm set up. Both groups are offered counseling and education regarding the importance of compliance to intranasal steroid upon recruitment. Daily reminder to take medication may eliminate reason for forgetting medication schedule, hence, improve compliance towards INCS among patients with allergic rhinitis. This study aims to assess the effectiveness of using daily mobile alarm on patient's compliance towards INCS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

The participant will be assigned a study number based on the recruitment timeline and assigned into the pre-randomized groups. Throughout the study, the primary investigator will not know which group is assigned for the mobile phone daily alarm. A second investigator will select the group for mobile phone daily alarm and set the alarm.

入排标准

年龄范围
15 Years 至 66 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients aged 15 years old to 60 years old with persistent AR
  • Positive SPT towards DF, DP, BT, cockroach, Aspergillus, Cat fur
  • Own and able to operate functioning mobile smartphone with built in alarm
  • Able to understand simple instructions
  • Patients who can read in English and Malay
  • Newly diagnosed AR or previous patients who only take intranasal corticosteroid less than 4 times per week

排除标准

  • • Patients on immunotherapy
  • Patients with mild intermittent AR
  • Pregnant patients
  • Patient with psychiatric illness
  • Patients with gross anatomical obstruction (severe DNS, gross polyposis, nasal tumour)
  • Chronic rhinosinusitis(CRS) with or without nasal polyposis
  • Patients who have adverse reaction towards INCS
  • Patients with severe hearing loss

结局指标

主要结局

Compliance

时间窗: 30 days

Compliance was taken as 2/3rd use of INCS (20 days out of 30) = 20 x 0.38 = 7.6 g reduced weight.

次要结局

未报告次要终点

研究者

发起方
National University of Malaysia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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