Cystic Fibrosis Remote Monitoring System

NCT04453358 | Unknown DMC FDA Device

• 1 other identifier: R44MD010177
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Lung Function

  180 days

• Quality of Life Measurement

  180 days

• CF Respiratory Symptoms

  180 days

Study Arms (2)

Interactive coaching

ACTIVE COMPARATOR

Airway clearance therapy using goal setting and interactive feedback.

Device: InCourage-Connect

Standard of care coaching

ACTIVE COMPARATOR

Standard of care airway clearance therapy.

Device: InCourage

Interventions

InCourage-Connect 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.

Interactive coaching

InCourage DEVICE

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

Standard of care coaching

Eligibility Criteria

• Age: 14 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Koronis Biomedical Technologies: lead
• Johns Hopkins University: collaborator

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Noah Lechtzin, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noah Lechtzin, MD

CONTACT

(410) 502-7044; nlechtz1@jhmi.edu

Patrick Lichter

CONTACT

6127301091; plichter@koronisbiotech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 1, 2020
• Study Start: September 1, 2020
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share