Clinical trial NCT03637504: Feasibility of a Mobile Medication Plan Application in CF Patient Care
Official title: Feasibility of a Mobile Medication Plan Application in CF Patient Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Cystic Fibrosis in Children
Keywords: Feasibility
Mobile Medication Plan Application
Patient Care
Nebulized Medications
Oral Medications
MedActionPlan
eTrack Nebulizer
AdhereTech Pill Bottles
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Arizona
name: Johns Hopkins University
name: Cystic Fibrosis Foundation
First posted: 2018-08-20
Enrollment: 105
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


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

Primary outcomes:
measure: mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients assessed by likert scale
timeFrame: week 24
measure: mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for clinicians assessed by likert scale
timeFrame: up to 30 months
Secondary outcomes:
measure: change in Knowledge of Disease Management-CF questionnaire (KDM-CF) scores
timeFrame: Day 1 to approximately week 24
measure: change in CF Medication Belief Questionnaire (CF-MBQ) scores
timeFrame: Day 1 to approximately week 24
measure: Mean change in adherence
timeFrame: Day 1 to approximately week 24
measure: change in CF Medication Questionnaire (CF-MQ) scores
timeFrame: Day 1 to approximately week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Tucson
country: United States
facility: University of Arizona and Banner Health
state: Arizona
city: Stanford
country: United States
facility: Lucille Packard Children's Hospital Stanford
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University of Michigan
name: Hanna Phan
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Cori Daines
role: PRINCIPAL_INVESTIGATOR
References: