Acceptability, feasibility and impacts of remote symptom monitoring and automated treatment plans in children with Cystic Fibrosis (CF) on highly effective modulators: a pilot randomised controlled trial.

Not Applicable

• Conditions: Cystic Fibrosis; Respiratory - Other respiratory disorders / diseases; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12623000152628
• Lead Sponsor: Royal Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-16
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Diagnosis of Cystic Fibrosis
-On a highly effective modulator (either ivacaftor or elexacaftor–tezacaftor–ivacaftor for a minimum of 2 weeks)
-Clinically stable without antibiotic treatment for a pulmonary exacerbation in 2 weeks prior to consent
-Attending RCH CF clinic
-Able to complete home spirometry (standard of care for all children with CF >5 years at RCH CF clinic)
-Sufficient English to complete a survey
-Access to a smart phone to access remote symptom monitoring surveys

Exclusion Criteria

-Participants not signed up or not willing to sign up to the RCH Portal (note that 80% of RCH CF patients are already signed up to the portal)
-Participants who do not have access to a smartphone or computer on a daily basis
-Participants who do not have access to a home spirometer for lung function purposes
-Participants will be excluded from the study for technological access reasons such as lack of access to the RCH Portal and IT equipment as this is the basis of the intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified