Cystic FibrosisNCT04687475
Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis
A study testing Clinical Tool (Mobile Spirometry and Survey) in people with Cystic Fibrosis and Lung Transplant; Complications, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Lung Transplant; Complications
- What is being tested?
- Clinical Tool (Mobile Spirometry and Survey)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to 1 Feb 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Cystic Fibrosis
- To be listed for lung transplant
- Has purchased home spirometer
Who cannot join
- Diagnosis other than Cystic Fibrosis
- Unable to read
- Unable to use computer or smartphone device to access mobile application
Trial locations and contacts
1 site in 1 country.
About this study
Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis
Read the detailed description
The aim of this project is to implement a clinical tool utilizing predictors of mortality for patients with Cystic Fibrosis (CF) on the waiting list to identify candidates that should present for urgent medical care and, if appropriate, will prompt clinicians to update a candidate's lung allocation score (LAS), the score used to prioritize lung transplant candidates for transplant by medical urgency, and avoid undetected decline. The clinical tool consists of home spirometry measures and patient reported outcomes that is completed weekly on a mobile application device used clinically to track spirometry.
- Conditions
- Cystic Fibrosis, Lung Transplant; Complications
- Being tested
- Clinical Tool (Mobile Spirometry and Survey)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Tool (Mobile Spirometry and Survey)Other
The clinical tool is a combination of home spirometry measurements and a patient survey measuring patient reported outcomes including the Cystic Fibrosis Respiratory Symptom Diary (CFRSD) and Chronic Respiratory Infection Symptom Score (CRISS©), with permission from the Seattle Quality of Life Group.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Tool (Mobile Spirometry and Survey) | Experimental | All subjects enrolled will be placed into the clinical tool arm. The clinical tool is comprised of a mobile application based assessment of home spirometry and a survey measuring patient reported outcomes. Receives: Other: Clinical Tool (Mobile Spirometry and Survey) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Allocation Score (LAS)
Change in LAS value at the first clinic visit triggered by the clinical tool
Measured: Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list).
Secondary outcomes (2)
Time to transplant
Measured in days (time spent on the lung transplant waiting list)
Measured: Through study completion, up to 1 year
Survival to transplant
Binary outcome measure to indicate if individual survived to transplant
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start20 Apr 2020
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
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.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687475
- Sponsor's protocol ID
- 19-112
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2020
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04687475
- Acronym / sponsor ID
- 19-112
- Conditions
- Cystic Fibrosis, Lung Transplant; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 29 Dec 2020 (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.
Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis
Detailed description
The aim of this project is to implement a clinical tool utilizing predictors of mortality for patients with Cystic Fibrosis (CF) on the waiting list to identify candidates that should present for urgent medical care and, if appropriate, will prompt clinicians to update a candidate's lung allocation score (LAS), the score used to prioritize lung transplant candidates for transplant by medical urgency, and avoid undetected decline. The clinical tool consists of home spirometry measures and patient reported outcomes that is completed weekly on a mobile application device used clinically to track spirometry.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Tool (Mobile Spirometry and Survey) | Experimental | Other: Clinical Tool (Mobile Spirometry and Survey)All subjects enrolled will be placed into the clinical tool arm. The clinical tool is comprised of a mobile application based assessment of home spirometry and a survey measuring patient reported outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Cystic Fibrosis
- To be listed for lung transplant
- Has purchased home spirometer
Key exclusion criteria (3 listed)
- Diagnosis other than Cystic Fibrosis
- Unable to read
- Unable to use computer or smartphone device to access mobile application
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 |
|---|---|---|
| Clinical Tool (Mobile Spirometry and Survey)The clinical tool is a combination of home spirometry measurements and a patient survey measuring patient reported outcomes including the Cystic Fibrosis Respiratory Symptom Diary (CFRSD) and Chronic Respiratory Infection Symptom Score (CRISS©), with permission from the Seattle Quality of Life Group. | Other | Clinical Tool (Mobile Spirometry and Survey) |
Primary outcome
Lung Allocation Score (LAS)
Time frame: Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list).
Change in LAS value at the first clinic visit triggered by the clinical tool
2 secondary outcomes
Time to transplant
Time frame: Through study completion, up to 1 year
Survival to transplant
Time frame: Through study completion, up to 1 year
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 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
Recruiting
Long-term Evaluation of the SIMEOX Device at Home in Non-cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Tool (Mobile Spirometry and Survey) in people with Cystic Fibrosis and Lung Transplant; Complications, run by The Cleveland Clinic at 1 site in United States.
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 3 inclusion and 3 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Lung Allocation Score (LAS) (time frame: Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list).). 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 29 Jul 2026.