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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03434886
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Information provided by (Responsible Party):
Abaigeal Jackson, Cystic Fibrosis Registry of Ireland

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: CFView Other: CF educational videos Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating Outcomes in European Cystic Fibrosis Patients With Access to Their Health Records: a Randomised Control Trial of a Registry Patient Portal
Actual Study Start Date : March 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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

Primary Outcome Measures :
  1. FEV1pp [ Time Frame: 18 months ]
    forced expiratory volume in 1 second percentage predicted

Secondary Outcome Measures :
  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 ]

  4. Pulmonary exacerbations [ Time Frame: 18 months ]
    pulmonary exacerbation requiring IV antibiotics

  5. Hospitalisations [ Time Frame: 18 months ]
    hospitalisation for treatment of pulmonary exacerbation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • organ transplantation
  • FEV1pp <40
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Responsible Party: Abaigeal Jackson, Research Lead, Cystic Fibrosis Registry of Ireland Identifier: NCT03434886    
Other Study ID Numbers: CFView
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases