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

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:

  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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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®