Cystic FibrosisCFViewNCT03434886
Outcomes in CF Patients Accessing Their Registry Health Records
A study testing CFView and CF educational videos in people with Cystic Fibrosis, run by Cystic Fibrosis Registry of Ireland.
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… Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- CFView and CF educational videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed with CF
- registered with their national CF patient registry
- FEV1pp ≥40
- aged 13-30 years
Who cannot join
- organ transplantation
- FEV1pp <40
About this study
Official title: Evaluating Outcomes in European Cystic Fibrosis Patients With Access to Their Health Records: a Randomised Control Trial of a Registry Patient Portal
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.
- Conditions
- Cystic Fibrosis
- Being tested
- CFView, CF educational videos
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFViewOther
Registry patient portal
CF educational videosOther
CF educational videos
| Study group | Role | What they receive |
|---|---|---|
| CF View | Experimental | Not described Receives: Other: CFView |
| CF Educational videos | Active comparator | Not described Receives: Other: CF educational videos |
| CF View and videos | Active comparator | Not described Receives: Other: CFView; Other: CF educational videos |
| Usual standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1pp
forced expiratory volume in 1 second percentage predicted
Measured: 18 months
Secondary outcomes (5)
Health literacy
Health Literacy Survey - HLS- EU - Q16 score
Measured: 12 months
Health-related quality of life
CFQr score - (Cystic Fibrosis questionnaire revised)
Measured: 12 months
BMI
kg/m^2
Measured: 18 months
Pulmonary exacerbations
pulmonary exacerbation requiring IV antibiotics
Measured: 18 months
Hospitalisations
hospitalisation for treatment of pulmonary exacerbation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study startMar 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cystic Fibrosis Registry of Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abaigeal Jackson, Cystic Fibrosis Registry of Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434886
- Sponsor's protocol ID
- CFView
- Acronym
- CFView
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Outcomes in European Cystic Fibrosis Patients With Access to Their Health Records: a Randomised Control Trial of a Registry Patient Portal
- ClinicalTrials.gov ID
- NCT03434886
- Acronym / sponsor ID
- CFView / CFView
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Cystic Fibrosis Registry of IrelandUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- diagnosed with CF
- registered with their national CF patient registry
- FEV1pp ≥40
- aged 13-30 years
Key exclusion criteria (2 listed)
- organ transplantation
- FEV1pp <40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CFViewRegistry patient portal | Other | CF View, CF View and videos |
| CF educational videosCF educational videos | Other | CF Educational videos, CF View and videos |
Primary outcome
FEV1pp
Time frame: 18 months
forced expiratory volume in 1 second percentage predicted
5 secondary outcomes
Health literacy
Time frame: 12 months
Health-related quality of life
Time frame: 12 months
BMI
Time frame: 18 months
Pulmonary exacerbations
Time frame: 18 months
Hospitalisations
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CFView and CF educational videos in people with Cystic Fibrosis, run by Cystic Fibrosis Registry of Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1pp (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.