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临床试验/NCT03847142
NCT03847142已完成不适用

Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年3月1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
入组人数
110
试验地点
1
主要终点
Change from baseline asthma quality of life to 2, 6, and 12 months

研究概览

简要总结

Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.

详细描述

Through this study, the investigators will use patient and provider feedback to adapt the ASTHMAXcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • •English-speaking individuals >18 years with:
  • •persistent asthma(diagnosis made by a healthcare provider) on a daily controller medication
  • •able to give informed consent
  • •Smartphone (iOS or Android) access

排除标准

  • •use of oral corticosteroids in the 2 weeks prior to the baseline visit
  • •severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol
  • •patients that previously received ASTHMAXcel

研究组 & 干预措施

ASTHMAXcel arm

Experimental

The ASTHMAXcel arm represents the study intervention, which is a patient-facing mobile application for adult patients with asthma.

干预措施: ASTHMAXcel mobile application (Other)

Usual care arm

Active Comparator

This arm represents usual care delivered in the outpatient primary care setting at the study sites.

干预措施: Outpatient primary care (Other)

结局指标

主要结局

Change from baseline asthma quality of life to 2, 6, and 12 months

时间窗: Baseline, 2 months, 6 months, 12 months

Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)

次要结局

  • Number of asthma emergency department visits(Baseline, 2 months, 6 months, 12 months)
  • Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire(Baseline, 2 months, 6 months, 12 months)
  • Change from baseline asthma control to 2, 6, and 12 months(Baseline, 2 months, 6 months, 12 months)
  • Patient satisfaction measured by the Client Satisfaction Questionnaire-8(Baseline, 2 months, 6 months, 12 months)
  • Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire(Baseline, 2 months, 6 months, 12 months)
  • Change from baseline asthma knowledge to 2 months, 6 months, and 12 months(Baseline, 2 months, 6 months, 12 months)
  • Depression as measured by the Patient Health Questionnaire-9(Baseline, 2 months, 6 months, 12 months)
  • Number of asthma hospitalizations(Baseline, 2 months, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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