Cystic Fibrosis
Conditions
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.
Interventions
OTHERCFView
Registry patient portal
OTHERCF educational videos
CF educational videos
Sponsors
Cystic Fibrosis Registry of Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed with CF * registered with their national CF patient registry * FEV1pp ≥40 * aged 13-30 years
Exclusion criteria
* organ transplantation * FEV1pp \<40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1pp | 18 months | forced expiratory volume in 1 second percentage predicted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health literacy | 12 months | Health Literacy Survey - HLS- EU - Q16 score |
| Health-related quality of life | 12 months | CFQr score - (Cystic Fibrosis questionnaire revised) |
| BMI | 18 months | kg/m\^2 |
| Pulmonary exacerbations | 18 months | pulmonary exacerbation requiring IV antibiotics |
| Hospitalisations | 18 months | hospitalisation for treatment of pulmonary exacerbation |
Outcome results
None listed