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NCT03434886 Clinical Trial

Outcomes in CF Patients Accessing Their Registry Health Records

Cystic Fibrosis Clinical Trial

— CFView  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03434886
Other study ID # CFView
Secondary ID
Status Completed
Phase N/A
First received February 8, 2018
Last updated February 14, 2018
Start date March 2016
Est. completion date September 2017

Study information
Verified date February 2018
Source Cystic Fibrosis Registry of Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 282
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 13 Years to 30 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• CFView
Registry patient portal
• CF educational videos
CF educational videos

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cystic Fibrosis Registry of Ireland

Outcome
Type Measure Description Time frame Safety issue
Primary FEV1pp forced expiratory volume in 1 second percentage predicted 18 months
Secondary Health literacy Health Literacy Survey - HLS- EU - Q16 score 12 months
Secondary Health-related quality of life CFQr score - (Cystic Fibrosis questionnaire revised) 12 months
Secondary BMI kg/m^2 18 months
Secondary Pulmonary exacerbations pulmonary exacerbation requiring IV antibiotics 18 months
Secondary Hospitalisations hospitalisation for treatment of pulmonary exacerbation 18 months
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