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临床试验/NCT02999789
NCT02999789
已完成
不适用

Interventions to Help Asthma Clinical Adherence

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 13 人2017年1月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Asthma in Children
发起方
University of California, San Francisco
入组人数
13
试验地点
1
主要终点
Change in Percentage of Doses Received
状态
已完成
最后更新
3年前

概览

简要总结

To conduct a pilot test to estimate the effect of a novel reminder system in improving daily asthma controller medication adherence rates in children with monolingual Spanish-speaking guardians who have limited English Proficiency (LEP).

详细描述

The primary hypothesis is to conduct a pilot test to estimate the effect of the SmartInhaler device in improving daily asthma controller medication adherence rates in children with monolingual Spanish- speaking guardians who have LEP during a six-week intervention period when compared to baseline medication adherence rates in a preceding six-week run-in period. The secondary hypothesis is to determine whether the patient reminder system can improve asthma symptom control during the same six-week intervention period. The third hypothesis is to assess if there are specific, patient behavior characteristics which are associated with the success of a novel asthma medication reminder system.

注册库
clinicaltrials.gov
开始日期
2017年1月
结束日期
2019年11月
最后更新
3年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

入选标准

  • The investigators will recruit 30 participants ages 5 to 17 years with a diagnosis of persistent asthma who require a daily inhaled corticosteroid metered dose inhaler and whose guardian is the person responsible for administering their daily asthma medication.
  • The investigators will recruit only participants who have received or receive care at San Francisco General Hospital's 6M Children's Health Center.
  • The investigators will recruit participants whose daily inhaled corticosteroid are metered dose inhalers (MDI) of either Flovent (fluticasone propionate) HFA (Hydrofluoroalkane) or Qvar (beclamethasone dipropionate) HFA.
  • The Investigators will recruit only participants whose guardian responsible for administering their daily asthma medication has Limited English Proficiency (LEP) and whose primary language is Spanish.

排除标准

  • The Investigators will exclude participants whose guardian responsible for administering their daily asthma medication does not have a Bluetooth enabled cell phone capable of receiving text messages.
  • The Investigators will exclude participants whose guardian responsible for administering their daily asthma medication does not have an available reliable power outlet where they can recharge the battery of their SmartInhaler.
  • The Investigators will exclude participants whose guardian responsible for administering their daily asthma medication is unable to demonstrate correct medication technique based on standard evaluation (Press, 2011) after completion of a standard teaching protocol.
  • The Investigators will exclude participants with chronic lung disease.
  • The Investigators will exclude participants who do not have an operating system of iOS or Android on their cell phone and who have no data plan with their cellular phone plan.
  • The Investigators will exclude participants whose asthma medication regimen is being managed by an asthma subspecialist or health provider outside of the 6M Children's Health Center at San Francisco General Hospital.
  • The Investigators will exclude participants who are using an inhaled long acting beta-agonist (LABA) as part of their asthma management plan.

结局指标

主要结局

Change in Percentage of Doses Received

时间窗: Baseline and 6 weeks post intervention

Medication adherence for each medication was calculated as a percentage of the total number of doses received during the study period divided by the total number of doses prescribed. As a result, this percentage ranged from 0 to 100. Medication adherence percentages during both the run-in and intervention periods were measured and the differences between doses received between the two time periods was calculated for each patient.

次要结局

  • Asthma Symptom Control Score Change(Baseline and 6 weeks post intervention)

研究点 (1)

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