Feasibility of a Mobile Medication Plan Application in CF Patient Care

NCT03637504 | Completed

• 2 other identifiers: IRB-P00021541STRC-102-17-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 5

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

Keywords

Feasibility; Mobile Medication Plan Application; Patient Care; Nebulized Medications; Oral Medications; MedActionPlan; eTrack Nebulizer; AdhereTech Pill Bottles

Outcome Measures

Primary Outcomes (2)

• mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients assessed by likert scale

  This measure was developed for this specific study to evaluate feasibility and acceptability of patient use through aspects of usability and quality (engagement, usefulness, functionality/ease of use, aesthetics, information, and satisfaction) of the web portal and application. Assessed by 5 point Likert Scale: Strongly disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree

  week 24

• mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for clinicians assessed by likert scale

  This measure was developed for this specific study to evaluate feasibility and acceptability of clinician use through aspects of usability and quality (engagement, usefulness, functionality/ease of use, aesthetics, information, and satisfaction) of the web portal and application. Assessed by 5 point Likert Scale: Strongly disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree

  up to 30 months

Secondary Outcomes (4)

• change in Knowledge of Disease Management-CF questionnaire (KDM-CF) scores

  Day 1 to approximately week 24

• change in CF Medication Belief Questionnaire (CF-MBQ) scores

  Day 1 to approximately week 24

• Mean change in adherence

  Day 1 to approximately week 24

• change in CF Medication Questionnaire (CF-MQ) scores

  Day 1 to approximately week 24

Study Arms (3)

Interventional

EXPERIMENTAL

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

Behavioral: MedActionPlan®

Control

NO INTERVENTION

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

Optional Extension

OTHER

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

Behavioral: MedActionPlan®

Interventions

MedActionPlan® BEHAVIORAL

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

Also known as: MAP

Interventional; Optional Extension

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• University of Arizona: collaborator
• Johns Hopkins University: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (5)

Children's of Alabama

Birmingham, Alabama, 35233, United States

Location

University of Arizona and Banner Health

Tucson, Arizona, 85724, United States

Location

Lucille Packard Children's Hospital Stanford

Stanford, California, 94304, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Hanna Phan

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Cori Daines

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Chair of Success with Therapies Research Consortium

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 20, 2018
• Study Start: September 5, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)