Outcomes in CF Patients Accessing Their Registry Health Records (CFView)

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

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 Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: CFView; Other: CF educational videos

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CF View	Other: CFView; Registry patient portal
Active Comparator: CF Educational videos	Other: CF educational videos; CF educational videos
Active Comparator: CF View and videos	Other: CFView; Registry patient portal; Other: CF educational videos; CF educational videos
No Intervention: Usual standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1pp	forced expiratory volume in 1 second percentage predicted	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health literacy	Health Literacy Survey - HLS- EU - Q16 score	12 months
Health-related quality of life	CFQr score - (Cystic Fibrosis questionnaire revised)	12 months
BMI	kg/m^2	18 months
Pulmonary exacerbations	pulmonary exacerbation requiring IV antibiotics	18 months
Hospitalisations	hospitalisation for treatment of pulmonary exacerbation	18 months

Collaborators and Investigators

• Sponsor: Cystic Fibrosis Registry of Ireland

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: CFView

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No