Cystic Fibrosis Remote Monitoring System

Cystic Fibrosis Remote Monitoring System to Support Resource-Limited Communities

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.

Study Overview

• Status: Unknown
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: InCourage-Connect; Device: InCourage

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.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Lichter; Phone Number: 6127301091; Email: plichter@koronisbiotech.com
• Study Contact Backup: Name: Noah Lechtzin, MD; Phone Number: (410) 502-7044; Email: nlechtz1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interactive coaching; Airway clearance therapy using goal setting and interactive feedback.	Device: 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.
Active Comparator: Standard of care coaching; Standard of care airway clearance therapy.	Device: InCourage; This intervention will provide standard of care airway clearance therapy with no interactive feedback on treatment goals and usage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Clearance Therapy Adherence	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).	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Function	Intervention comparison of pre and post measures of FEV1 and FVC.	180 days
Quality of Life Measurement	Intervention comparison based upon pre and post Cystic Fibrosis Questionnaire Revised (CFQ-R). Name of categories/domains CFQ-R: 9 Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions. 3 symptom scales: Weight, respiratory, and digestion. Scaling of items: 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scoring: Scores for each domain; after recording, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.	180 days
CF Respiratory Symptoms	Intervention comparison based upon pre and post CF Respiratory Symptom Score (CRSS) assessment. The score evaluates four symptoms: cough, sputum, breathlessness and fatigue. Each symptom is scored from one (mild symptoms) to four (severe symptoms). The total symptom score was the summation of all the four symptoms. Scores range from 4 to 16 with 4 being mild to 16 being most severe.	180 days

Collaborators and Investigators

• Sponsor: Koronis Biomedical Technologies
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Noah Lechtzin, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: R44MD010177 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes