Trial Search Results

Feasibility of a Mobile Medication Plan Application in CF Patient Care

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Boston Children’s Hospital

Collaborator: Cystic Fibrosis Foundation

Stanford Investigator(s):

Intervention(s):

  • Behavioral: MedActionPlan®

Phase:

N/A

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

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting