Outcomes in CF Patients Accessing Their Registry Health Records

Cystic Fibrosis Registry of Ireland282 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

282

Conditions

Cystic Fibrosis

Interventions

CFViewOTHER

Registry patient portal

CF educational videosOTHER

CF educational videos

Eligibility

Sex: ALLMin age: 13 YearsMax age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosed with CF * registered with their national CF patient registry * FEV1pp ≥40 * aged 13-30 years Exclusion Criteria: * organ transplantation * FEV1pp \<40

Outcomes

Primary Outcomes

FEV1pp

forced expiratory volume in 1 second percentage predicted

Time frame: 18 months

Secondary Outcomes

Health literacy

Health Literacy Survey - HLS- EU - Q16 score

Time frame: 12 months

Health-related quality of life

CFQr score - (Cystic Fibrosis questionnaire revised)

Time frame: 12 months

BMI

kg/m\^2

Time frame: 18 months

Pulmonary exacerbations

pulmonary exacerbation requiring IV antibiotics

Time frame: 18 months

Hospitalisations

hospitalisation for treatment of pulmonary exacerbation

Time frame: 18 months

Data from ClinicalTrials.gov

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