MedPath

Outcomes in CF Patients Accessing Their Registry Health Records

Not Applicable
Completed
Conditions
Cystic Fibrosis
Interventions
Other: CFView
Other: CF educational videos
Registration Number
NCT03434886
Lead Sponsor
Cystic Fibrosis Registry of Ireland
Brief Summary

A multifactorial, parallel group, randomised control study in cystic fibrosis (CF) patients aged 13-30 years over an 18 month period. Patients will be offered read-only access to their CF registry electronic health record (CF View), or educational videos on CF (videos), or videos and CF View, or usual standard of care. The study aims are to examine the effect of patient access to C View on a range of clinical outcomes, health service usage, health literacy and patient reported outcomes.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
282
Inclusion Criteria
  • diagnosed with CF
  • registered with their national CF patient registry
  • FEV1pp ≥40
  • aged 13-30 years
Exclusion Criteria
  • organ transplantation
  • FEV1pp <40

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CF ViewCFView-
CF View and videosCFView-
CF Educational videosCF educational videos-
CF View and videosCF educational videos-
Primary Outcome Measures
NameTimeMethod
FEV1pp18 months

forced expiratory volume in 1 second percentage predicted

Secondary Outcome Measures
NameTimeMethod
Health literacy12 months

Health Literacy Survey - HLS- EU - Q16 score

Health-related quality of life12 months

CFQr score - (Cystic Fibrosis questionnaire revised)

BMI18 months

kg/m\^2

Pulmonary exacerbations18 months

pulmonary exacerbation requiring IV antibiotics

Hospitalisations18 months

hospitalisation for treatment of pulmonary exacerbation

© Copyright 2025. All Rights Reserved by MedPath