NCT03434886

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

February 8, 2018

Last Update Submit

February 14, 2018

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • FEV1pp

    forced expiratory volume in 1 second percentage predicted

    18 months

Secondary Outcomes (5)

  • Health literacy

    12 months

  • Health-related quality of life

    12 months

  • BMI

    18 months

  • Pulmonary exacerbations

    18 months

  • Hospitalisations

    18 months

Study Arms (4)

CF View

EXPERIMENTAL
Other: CFView

CF Educational videos

ACTIVE COMPARATOR
Other: CF educational videos

CF View and videos

ACTIVE COMPARATOR
Other: CFViewOther: CF educational videos

Usual standard of care

NO INTERVENTION

Interventions

CFViewOTHER

Registry patient portal

CF ViewCF View and videos
CF educational videosOTHER

CF educational videos

CF Educational videosCF View and videos

Eligibility Criteria

Age13 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • organ transplantation
  • FEV1pp \<40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Lead

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 15, 2018

Study Start

March 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share