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Can a smartphone app reveal how CF treatments really work at home?

NCT ID NCT04798014

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study follows people with cystic fibrosis who are taking a highly effective medication called elexacaftor/tezacaftor/ivacaftor (ETI). Participants use a mobile app to report their daily symptoms, medication use, and any changes in their health over 12 months. The goal is to understand how the treatment performs in real-world settings, outside of a clinic.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elexacaftor/tezacaftor/ivacaftor (ETI) therapy
What this could lead to
If successful, this could provide a clearer picture of how well CF treatments work in daily life, helping doctors and patients make more informed decisions.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by how accurately participants report their symptoms and habits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

860 people

The number who actually took part.

Started

May 2021

Finished

Aug 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals diagnosed with Cystic Fibrosis, and who are on ETI through an FDA-labeled indication are eligible for this study. Study participants will be using Folia Health, a web-based application to track daily care and must have access to a mobile phone or computer with an internet connection.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian. * Is willing and able to adhere to protocol requirements. * ≥ 12 years of age at enrollment. * Diagnosed with CF. * Prescribed ETI for an on-label indication. * Participant has access to a mobile phone or tablet (iPhone or Android platform) or computer. * Participant has access to an internet connection. Exclusion Criteria: * Participant is enrolled in the randomized portion of the SIMPLIFY study (NCT04378153). * Participant does not have access to the necessary technology. * Participant is a recipient of a solid organ transplant (i.e. lung, liver, pancreas, kidney). * Participant cannot communicate in English.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystic fibrosis

Contacts and locations

Locations

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.