Feasibility of a Mobile Medication Plan Application in CF Patient Care
Completed · Not applicable
Conditions studied: Cystic Fibrosis, Cystic Fibrosis in Children
In brief
This is a pilot, multicenter, prospective, randomized controlled study to evaluate the feasibility of an innovative medication adherence intervention utilizing a web-based, mobile medication management application \[MedActionPlan® (MAP)\] to encourage self-management by reinforcing adherence and education about treatment regimens in Participants with cystic fibrosis (CF) (ages 12 years and older). Outcomes of interest for this study are 1) feasibility of MAP in real-world setting which will be evaluated using patient/caregiver and clinician feedback regarding value, ease of use, and challenges with use, 2) effect of MAP on patient/caregiver knowledge and perception of medication use, 3) effect of MAP on adherence to inhaled and oral medications used in chronic management of CF. Preliminary data regarding outcomes on exacerbations, lung function, and health care system utilization (e.g., emergency department visits, hospitalization) will also be examined as part of this study.
Key facts
- Study ID
- NCT03637504
- Run by
- Boston Children's Hospital
- People needed
- 105
- Starts
- 2018-09-05
- Expected to finish
- 2021-06-30
- Last updated by the study team
- 2021-08-03
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- CLINICIAN PARTICIPANTS:
- A CF care team member from any discipline, designated by the site principal investigator (PI) and CF team
- Willing to use MAP as part of CF care
- PATIENT PARTICIPANTS:
- Male or female patients ages ≥ 12 years of age at Study Visit 1
- Documentation of a CF diagnosis (physician diagnosed)
- Ability to understand verbal and written English
- Access to mobile device such as a tablet or smartphone (iPhone/iPad/iTouch or Android device)
- Willingness to use the MAP application
- 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)
- Child is consented to participate in the study.
- Ability to understand verbal and written English
You may not qualify if…
- 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:
- Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in own care
- 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
- Planned or scheduled hospitalization during study period of up to 36 weeks
- CAREGIVER PARTICIPANTS:
- (for Patient Participants age < 18 years)
- Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in child's or own care
Where it is running
- Children's of Alabama — Birmingham, Alabama, United States
- University of Arizona and Banner Health — Tucson, Arizona, United States
- Lucille Packard Children's Hospital Stanford — Stanford, California, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- University at Buffalo — Buffalo, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.