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Feasibility of a Mobile Medication Plan Application in CF Patient Care
Not Recruiting
Trial ID: NCT03637504
Purpose
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.
Official Title
Feasibility of a Mobile Medication Plan Application in CF Patient Care
Stanford Investigator(s)
Eligibility
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
Intervention(s):
behavioral: MedActionPlan®
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305