Clinical Trials Logo
  1. Home
  2. Cystic Fibrosis
  3. NCT03434886
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT04696198 - Thoracic Mobility in Cystic Fibrosis Care N/A
Completed NCT00803205 - Study of Ataluren (PTC124™) in Cystic Fibrosis Phase 3
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03601637 - Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del Phase 3
Terminated NCT02769637 - Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
Recruiting NCT06012084 - The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis N/A
Recruiting NCT06030206 - Lung Transplant READY CF 2: A Multi-site RCT N/A
Recruiting NCT06032273 - Lung Transplant READY CF 2: CARING CF Ancillary RCT N/A
Recruiting NCT05392855 - Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF) N/A
Recruiting NCT06088485 - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Recruiting NCT04039087 - Sildenafil Exercise: Role of PDE5 Inhibition Phase 2/Phase 3
Recruiting NCT04056702 - Impact of Triple Combination CFTR Therapy on Sinus Disease.
Completed NCT04038710 - Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
Completed NCT04058548 - Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation N/A
Completed NCT03637504 - Feasibility of a Mobile Medication Plan Application in CF Patient Care N/A
Recruiting NCT03506061 - Trikafta in Cystic Fibrosis Patients Phase 2
Completed NCT03566550 - Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Completed NCT04568980 - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Recruiting NCT04010253 - Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis N/A