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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CFView
CF educational videos
Sponsored by
Cystic Fibrosis Registry of Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis

Eligibility Criteria

13 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • organ transplantation
  • FEV1pp <40

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    CF View

    CF Educational videos

    CF View and videos

    Usual standard of care

    Arm Description

    Outcomes

    Primary Outcome Measures

    FEV1pp
    forced expiratory volume in 1 second percentage predicted

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 8, 2018
    Last Updated
    February 14, 2018
    Sponsor
    Cystic Fibrosis Registry of Ireland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03434886
    Brief Title
    Outcomes in CF Patients Accessing Their Registry Health Records
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    September 2017 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cystic Fibrosis Registry of Ireland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    282 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CF View
    Arm Type
    Experimental
    Arm Title
    CF Educational videos
    Arm Type
    Active Comparator
    Arm Title
    CF View and videos
    Arm Type
    Active Comparator
    Arm Title
    Usual standard of care
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    CFView
    Intervention Description
    Registry patient portal
    Intervention Type
    Other
    Intervention Name(s)
    CF educational videos
    Intervention Description
    CF educational videos
    Primary Outcome Measure Information:
    Title
    FEV1pp
    Description
    forced expiratory volume in 1 second percentage predicted
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Health literacy
    Description
    Health Literacy Survey - HLS- EU - Q16 score
    Time Frame
    12 months
    Title
    Health-related quality of life
    Description
    CFQr score - (Cystic Fibrosis questionnaire revised)
    Time Frame
    12 months
    Title
    BMI
    Description
    kg/m^2
    Time Frame
    18 months
    Title
    Pulmonary exacerbations
    Description
    pulmonary exacerbation requiring IV antibiotics
    Time Frame
    18 months
    Title
    Hospitalisations
    Description
    hospitalisation for treatment of pulmonary exacerbation
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosed with CF registered with their national CF patient registry FEV1pp ≥40 aged 13-30 years Exclusion Criteria: organ transplantation FEV1pp <40

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Outcomes in CF Patients Accessing Their Registry Health Records

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