Feasibility of a Mobile Medication Plan Application in CF Patient Care (MAP)

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Boston Children's Hospital

Status

Completed

Conditions

Cystic Fibrosis in Children
Cystic Fibrosis

Treatments

Behavioral: MedActionPlan®

Study type

Interventional

Funder types

Other

Identifiers

NCT03637504
STRC-102-17-01 (Other Identifier)
IRB-P00021541

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

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:

  • 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)

1. Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in child's or own care

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 3 patient groups

Interventional
Experimental group
Description:
web-based, mobile medication management application [MedActionPlan® (MAP) and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
Treatment:
Behavioral: MedActionPlan®
Control
No Intervention group
Description:
usual care and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
Optional Extension
Other group
Description:
web-based, mobile medication management application [MedActionPlan® (MAP)]
Treatment:
Behavioral: MedActionPlan®

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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