A Proof-of-concept, Open-label, Feasibility Study to Evaluate Mobile Applications and Biosensing (mHealth) Devices to Monitor Physical Activity and Respiratory Function in Smokers With and Without Respiratory Symptoms/COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Rate of Recruitment
研究概览
简要总结
This study examines the feasibility and acceptability of using mobile applications and biosensing (mHealth) devices in detecting vitality parameters in current smokers with and without respiratory symptoms/COPD (e.g., heart rate, blood oxygenation, steps/motion) for a future big-scale study.
详细描述
The study is designed to investigate feasibility of using mHealth devices to improve the treatment, assessment, compliance, and outcomes in smokers with and without respiratory symptoms/COPD. The study aims to reveal and address the anticipated barriers to the acceptance and implementation of mHealth devices in this patient population and clinical setting. As is well documented, the more attention patients receive from medical personnel, the better their clinical outcomes. Here we are attempting to use device-driven monitoring applications, interactive reminders, and teaching modules to deliver a constant positive feedback loop to patients to improve their health decisions.
Objectives of the study:
To assess the feasibility of using mHealth devices in current smokers with and without respiratory symptoms/COPD.
To assess the utility (i.e., validity and reproducibility) of mHealth devices in detecting vitality parameters in current smokers with and without respiratory symptoms/COPD (e.g., heart rate; blood oxygenation; steps/motion; FEV1, FVC, and their ratio; peak expiratory flow [PEF]).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current smokers who are currently smoking conventional cigarettes with a minimum of 10 pack-year smoking history
- •Able to use and willing to be trained to use mHealth devices
排除标准
- •COPD exacerbation that has not resolved at least 28 days prior to screening
- •COPD exacerbation occurring after screening but before the first study visit
- •Pneumonia or other respiratory tract infections that have not resolved at least 14 days prior to screening
- •Pneumonia occurring after screening but before the first study visit
- •Active respiratory disorders: tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, bronchial asthma, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases
- •Any co-morbid medical condition that in the opinion of the investigator would make participation in the study unsafe or unfeasible, including conditions that prohibit completion of exercise testing
- •Use of supplemental oxygen therapy
- •Inability to abstain from smoking during the period in which the participant is admitted to the Kazakhstan Academy of Preventive Medicine (KAPM) COPD Center
- •A history of allergy or hypersensitivity to metal, particularly stainless steel
- •Any vital sign indicator, for example, hypertension or tachycardia at rest that, at the discretion of the investigator, would make participation in the study unsafe or unfeasible
- •Women who test positive for pregnancy during screening, lactating women, or women planning on becoming pregnant during the study
- •Participants using assistive devices like walking aids, as these are likely to interfere with physical activity
结局指标
主要结局
Rate of Recruitment
时间窗: Baseline
Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Rate of Retention
时间窗: through study completion, an average of 90 days
Retention is defined as the proportion of participants enrolled who completed the intervention and all study measures.
Protocol Adherence
时间窗: through study completion, an average of 90 days
Adherence to the study protocol is determined as the proportion of participants enrolled from whom all mHealth parameters registered every day.
次要结局
未报告次要终点