Cystic Fibrosis Remote Monitoring System

Koronis Biomedical Technologies

Status: Unknown

Conditions: Cystic Fibrosis

Treatments: Device: InCourage-Connect; Device: InCourage

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04453358

R44MD010177

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 14 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Interactive coaching

Active Comparator group

Description:

Airway clearance therapy using goal setting and interactive feedback.

Treatment:

Device: InCourage-Connect

Standard of care coaching

Active Comparator group

Description:

Standard of care airway clearance therapy.

Treatment:

Device: InCourage