Outcomes in CF Patients Accessing Their Registry Health R... | NCT03434886

Studies
Outcomes in CF Patients Accessing Their Registry Health Records

NCT03434886

Sponsor

Cystic Fibrosis Registry of Ireland

Status

Completed

Last Update Posted

Feb 15, 2018Actual

Enrollment

282Actual

Phase

Not Applicable

Conditions

Cystic Fibrosis

Interventions

CFView
CF educational videos

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Feb 8, 2018

First Submission Date that Met QC Criteria

Feb 14, 2018

First Posted Date

Feb 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2018

Last Update Posted Date

Feb 15, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abaigeal Jackson, Research Lead, Cystic Fibrosis Registry of IrelandPrincipal Investigator

Lead Sponsor

Cystic Fibrosis Registry of IrelandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

282Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
CF View	Experimental	Other: CFView
CF Educational videos	Active Comparator	Other: CF educational videos
CF View and videos	Active Comparator	Other: CFView Other: CF educational videos
Usual standard of care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CFView	Other	Registry patient portal	CF View CF View and videos

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided