Cystic Fibrosis Remote Monitoring System

NCT ID: NCT04453358

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-08-31

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interactive coaching

Airway clearance therapy using goal setting and interactive feedback.

Group Type: ACTIVE_COMPARATOR

InCourage-Connect

Intervention Type: DEVICE

This intervention will provide patients with clearly stated treatment goals and provide them with interactive feedback based on usage date to help support airway clearance therapy adherence.

Standard of care coaching

Standard of care airway clearance therapy.

Group Type: ACTIVE_COMPARATOR

InCourage

Intervention Type: DEVICE

This intervention will provide standard of care airway clearance therapy with no interactive feedback on treatment goals and usage.

Interventions

InCourage-Connect

This intervention will provide patients with clearly stated treatment goals and provide them with interactive feedback based on usage date to help support airway clearance therapy adherence.

Intervention Type: DEVICE

InCourage

This intervention will provide standard of care airway clearance therapy with no interactive feedback on treatment goals and usage.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Koronis Biomedical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noah Lechtzin, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Central Contacts

Noah Lechtzin, MD

Role: CONTACT

nlechtz1@jhmi.edu

(410) 502-7044

Patrick Lichter

Role: CONTACT

plichter@koronisbiotech.com

6127301091

Other Identifiers

R44MD010177

Identifier Type: NIH

Identifier Source: org_study_id

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