Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT03637504
Eligibility Criteria:
Inclusion Criteria:
* CLINICIAN PARTICIPANTS:
1. A CF care team member from any discipline, designated by the site principal investigator (PI) and CF team
2. Willing to use MAP as part of CF care
* PATIENT PARTICIPANTS:
1. Male or female patients ages ≥ 12 years of age at Study Visit 1
2. Documentation of a CF diagnosis (physician diagnosed)
3. Ability to understand verbal and written English
4. Access to mobile device such as a tablet or smartphone (iPhone/iPad/iTouch or Android device)
5. Willingness to use the MAP application
6. Currently taking at least one of the following chronic medications and willing to use AdhereTech pill bottles for oral medications and/or eTrack nebulizer for nebulized medications listed below: nebulized agents, dornase alfa, hypertonic saline, inhaled tobramycin, inhaled aztreonam, inhaled colistimethate, oral agents, azithromycin
* CAREGIVER PARTICIPANTS (for Patient Participants age \< 18 years)
1. Child is consented to participate in the study.
2. Ability to understand verbal and written English
Exclusion Criteria:
* CLINICIAN PARTICIPANTS:
Previous use of MAP (with patient(s) or self) in the last 12 months - when used with patients, defined as use in 5 or more patients
* PATIENT PARTICIPANTS:
1. Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in own care
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data including, but not limited to, diagnosis of intellectual or developmental disability (e.g., autism); and/or history of lung transplant
3. Planned or scheduled hospitalization during study period of up to 36 weeks
* CAREGIVER PARTICIPANTS:
(for Patient Participants age \< 18 years)
1\. Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in child's or own care
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03637504
Study Brief:
Protocol Section:
NCT03637504