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临床试验/NCT04453358
NCT04453358Unknown不适用

Cystic Fibrosis Remote Monitoring System to Support Resource-Limited Communities

Koronis Biomedical Technologies0 个研究点目标入组 35 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
35
主要终点
Airway Clearance Therapy Adherence

研究概览

简要总结

The objective of this study is to determine if interactive technology (i.e. virtual coaching) that facilitates vest therapy goal setting and provides positive reinforcement will increase adherence to vest therapy for airway clearance in individuals with CF.

详细描述

Cystic fibrosis (CF) is a life-limiting multi-system disease primarily characterized by chronic lung infections and pulmonary symptoms such as cough, dyspnea, and chest tightness. Those with CF rely on numerous pharmaceutical and treatment-based therapies as part of their routine care to maintain lung health. Airway clearance, one such treatment-based therapy, uses breathing techniques and various vibrating devices to mobilize lung secretions and is considered a cornerstone of CF care. Vest therapy, a "shaking vest" that applies pressure and high frequency vibrations to the chest wall is the most commonly used technique for airway clearance in the U.S., but adherence to recommended goals for airway clearance is low. Barriers to adherence include the time limitations and unclear goal setting for effective treatment. A previous pilot study by this research team showed that CF patients find the use of airway clearance vests equipped with both pre-set and individually determined programing capabilities as well as electronic monitoring and transmitting capabilities to be acceptable and feasible. Information such as vest-use time, vest pressure measures, programming choices and symptom reporting is captured by these devices and transmitted to health care teams for review as well as provided to patients to provide feedback on treatment goals. This study aims to determine if providing patients with clearly stated treatment goals and the means to monitor and receive positive reinforcing feedback on vest use through interactive technology (i.e. virtual coaching) will improve vest therapy adherence in individuals with CF.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
14 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Have a diagnosis of cystic fibrosis
  • •Be physically capable of and willing to use the study device
  • •Access to an internet connection
  • •Access to a mobile device capable of using applications
  • •Be familiar with how to utilize a mobile device and/or applications
  • •Self-reported CF-related therapy adherence between 25%-75% on a screening questionnaire

排除标准

  • •History of solid-organ transplant
  • •Inability to speak and read the English language
  • •Any contraindication to vest use for airway clearance

研究组 & 干预措施

Interactive coaching

Active Comparator

Airway clearance therapy using goal setting and interactive feedback.

干预措施: InCourage-Connect (Device)

Standard of care coaching

Active Comparator

Standard of care airway clearance therapy.

干预措施: InCourage (Device)

结局指标

主要结局

Airway Clearance Therapy Adherence

时间窗: 90 days

Intervention comparison of adherence measurements: a) to prescribed pressure based upon % of time at prescribed pressure and b) to prescribed duration of treatment based upon % of time using the airway clearance device at prescribed duration (weekly capture).

次要结局

  • Lung Function(180 days)
  • CF Respiratory Symptoms(180 days)
  • Quality of Life Measurement(180 days)

研究者

发起方
Koronis Biomedical Technologies
申办方类型
Industry
责任方
Sponsor

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