Outcomes in CF Patients Accessing Their Registry Health Records

NCT ID: NCT03434886

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CF View

Group Type EXPERIMENTAL

CFView

Intervention Type OTHER

Registry patient portal

CF Educational videos

Group Type ACTIVE_COMPARATOR

CF educational videos

Intervention Type OTHER

CF educational videos

CF View and videos

Group Type ACTIVE_COMPARATOR

CFView

Intervention Type OTHER

Registry patient portal

CF educational videos

Intervention Type OTHER

CF educational videos

Usual standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CFView

Registry patient portal

Intervention Type OTHER

CF educational videos

CF educational videos

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* organ transplantation
* FEV1pp \<40
Minimum Eligible Age

13 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Registry of Ireland

OTHER

Sponsor Role lead

Responsible Party

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Abaigeal Jackson

Research Lead

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CFView

Identifier Type: -

Identifier Source: org_study_id

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