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临床试验/NCT03248869
NCT03248869已完成不适用

Asthma Mobile Health Application 2.0

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 7,752 人开始时间: 2015年3月15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
7,752
试验地点
1
主要终点
Number of downloads

研究概览

简要总结

Mobile health applications (MHA) are increasingly being explored as tools to assist in management of chronic diseases. Little is known regarding which characteristics of MHAs are effective and there is limited data suggesting a real-world impact on health outcomes. Asthma is one of the most common and costly of the chronic diseases, impacting a broad range of the population including both children and adults. It is a variable disease necessitating regular medication use, monitoring of symptoms, and avoidance of specific triggers. These characteristics of asthma make it a chronic disease that is particularly amenable to having an MHA facilitate active monitoring outside of periodic traditional medical visits. The study team has designed a MHA focused on asthma subjects to test the feasibility of an asthma mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical care (that may take place during typical office visits), such as medication reminders, a daily asthma diary to track asthma control (AC) and medication use, patient education and assessments of quality of life (QoL), and health care utilization (HCU).

详细描述

Mobile health applications (MHA) are increasingly being explored as tools to assist in management of chronic diseases. Little is known regarding which characteristics of MHAs are effective and there is limited data suggesting a real-world impact on health outcomes. Asthma is one of the most common and costly of the chronic diseases, impacting a broad range of the population including both children and adults. It is a variable disease necessitating regular medication use, monitoring of symptoms, and avoidance of specific triggers. These characteristics of asthma make it a chronic disease that is particularly amenable to having an MHA facilitate active monitoring outside of periodic traditional medical visits. The study team has designed a MHA focused on asthma subjects to test the feasibility of an asthma mobile health application (AMHA). The AMHA 2.0 study is the result of a collaboration between MHA developers and Mount Sinai faculty with expertise in the fields of asthma, research design, data storage, and data analysis. AMHA 2.0 incorporated elements of usual clinical care (that may take place during typical office visits), such as medication reminders, a daily asthma diary to track asthma control (AC) and medication use, patient education and assessments of quality of life (QoL), and health care utilization (HCU).

During the AMHA 2.0 study, the aims are to evaluate the feasibility of:

  1. Consenting and enrolling a small cohort of subjects with asthma recruited from Mount Sinai pulmonary clinics remotely via downloading the app
  2. Feasibility of use of an asthma e-diary and automated e-reminders for medications in this small cohort for one month
  3. Exploring if a small cohort of participants will share data from wearable health and fitness monitoring devices if they own and use such devices.

The primary enrollment period for AMHA 2.0 was met in September 2015. More than 7,000 individuals e-consented for the AMHA 2.0 study, providing more than 80,000 survey responses with many participants granting AMHA 2.0 investigators access to geo-location and wellness data. Data collected during the first six months of the AMHA 2.0 study has provided evidence to answer all primary outcome measures.

Continuation of the AMHA 2.0 protocol was approved in December 2015, expanding the study to a larger population who will be followed for a more extended period of time and will be recruited via availability of the AMHA in the Apple App Store in the US, UK, and Ireland. The latest modification submitted in January, adds an entirely new aim, OM6 and SA6, to the project to include a genetics module. The objectives for the continuation study are:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Device Feasibility
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

入选标准

  • 18 years of age or older
  • Self-reported physician diagnosed asthma
  • Have an iPhone
  • Sufficient English-language ability to participate in informed consent process, complete study assessments and understand the text in mobile phone-delivered interventions

排除标准

  • <18 years of age
  • Not currently taking any asthma medications
  • Does not own an iPhone or know how to handle a mobile phone
  • Are unable to read or understand the study materials
  • Current pregnancy

研究组 & 干预措施

Current Daily Survey

Active Comparator

need description

干预措施: Current Daily Survey (Other)

Mobile Health App (MHA)

Experimental

Participants download the mobile health app via the Apple App Store

干预措施: Mobile Health App (Other)

结局指标

主要结局

Number of downloads

时间窗: 2 years

Number of people who downloaded AMHA

Percent of participants who aborted study participation

时间窗: 2 years

Percent of aborted study participants before completion inclusion/exclusion criteria

次要结局

  • Frequency of use of the Health Care Utilization (HCU) questionnaire(2 years)
  • Percent of completion of the Health Care Utilization (HCU) questionnaire(2 years)
  • Frequency of use of optional AMHA features(2 years)
  • Associations between genetic markers and symptom patterns(2 years)
  • EuroQol 5D-5L (EQ-5D-5L)(up to 6 months)
  • Frequency of use of the Asthma Control (AC) questionnaire(2 years)
  • Asthma Control (AC) questionnaire(up to 6 months)
  • Frequency of use of the Daily asthma diary(2 years)
  • Percent of completion of Daily asthma diary(2 years)
  • Percent of completion of the Asthma Control (AC) questionnaire(2 years)
  • Health Care Utilization (HCU) score(up to 6 months)
  • Associations between genetic markers and asthma severity(2 years)
  • Associations between genetic markers and medication use/response(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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