Skip to main content
OpenTrials
Completed

NCT Number: NCT03434886

Outcomes in CF Patients Accessing Their Registry Health Records

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

13 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with CF
  • registered with their national CF patient registry
  • FEV1pp ≥40
  • aged 13-30 years

Exclusion criteria

  • organ transplantation
  • FEV1pp <40

Treatment and study plan

CFView

Other

Registry patient portal

CF educational videos

Other

CF educational videos

Primary outcomes

  1. FEV1pp

    Time frame: 18 months

    forced expiratory volume in 1 second percentage predicted

Secondary outcomes

  1. Health literacy

    Time frame: 12 months

    Health Literacy Survey - HLS- EU - Q16 score

  2. Health-related quality of life

    Time frame: 12 months

    CFQr score - (Cystic Fibrosis questionnaire revised)

  3. BMI

    Time frame: 18 months

    kg/m^2

  4. Pulmonary exacerbations

    Time frame: 18 months

    pulmonary exacerbation requiring IV antibiotics

  5. Hospitalisations

    Time frame: 18 months

    hospitalisation for treatment of pulmonary exacerbation

Sponsors and collaborators

Lead sponsor

Cystic Fibrosis Registry of Ireland

Other

Registry information

Official study title

Evaluating Outcomes in European Cystic Fibrosis Patients With Access to Their Health Records: a Randomised Control Trial of a Registry Patient Portal

Acronym: CFView

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2018
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.