Feasibility of a Mobile Medication Plan Application in CF Patient Care

NCT ID: NCT03637504

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2021-06-30

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.

Conditions

Cystic Fibrosis; Cystic Fibrosis in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Interventional

web-based, mobile medication management application \[MedActionPlan® (MAP) and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence

Group Type: EXPERIMENTAL

MedActionPlan®

Intervention Type: BEHAVIORAL

web-based, mobile medication management application \[MedActionPlan® (MAP)\]

Control

usual care and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence

Group Type: NO_INTERVENTION

No interventions assigned to this group

Optional Extension

web-based, mobile medication management application \[MedActionPlan® (MAP)\]

Group Type: OTHER

MedActionPlan®

Intervention Type: BEHAVIORAL

web-based, mobile medication management application \[MedActionPlan® (MAP)\]

Interventions

MedActionPlan®

web-based, mobile medication management application \[MedActionPlan® (MAP)\]

Intervention Type: BEHAVIORAL

Other Intervention Names

MAP

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gregory Sawicki

Co-Chair of Success with Therapies Research Consortium

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanna Phan

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Cori Daines

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Children's of Alabama

Birmingham, Alabama, United States

University of Arizona and Banner Health

Tucson, Arizona, United States

Lucille Packard Children's Hospital Stanford

Stanford, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

University at Buffalo

Buffalo, New York, United States

Countries

United States

Other Identifiers

STRC-102-17-01

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-P00021541

Identifier Type: -

Identifier Source: org_study_id