Clinical trial NCT04453358: Cystic Fibrosis Remote Monitoring System
Official title: Cystic Fibrosis Remote Monitoring System to Support Resource-Limited Communities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Koronis Biomedical Technologies
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
First posted: 2020-07-01
Enrollment: 35
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized-comparative study investigating the effectiveness of either low-level virtual coaching vs. high-level virtual coaching in improving airway clearance treatment adherence.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Airway Clearance Therapy Adherence
timeFrame: 90 days
Secondary outcomes:
measure: Lung Function
timeFrame: 180 days
measure: Quality of Life Measurement
timeFrame: 180 days
measure: CF Respiratory Symptoms
timeFrame: 180 days
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Noah Lechtzin, MD
role: PRINCIPAL_INVESTIGATOR
References: