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

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ClinicalTrials.gov Identifier: NCT03637504
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
University of Arizona
Johns Hopkins University
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Gregory Sawicki, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE July 26, 2018
First Posted Date  ICMJE August 20, 2018
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE September 5, 2018
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients assessed by likert scale [ Time Frame: week 24 ]
    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
  • mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for clinicians assessed by likert scale [ Time Frame: up to 30 months ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03637504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • change in Knowledge of Disease Management-CF questionnaire (KDM-CF) scores [ Time Frame: Day 1 to approximately week 24 ]
    This validated measure was developed for studies of adherence and disease management. It assesses the practical knowledge of patients with CF. The measure evaluates knowledge of disease management in four areas (general health, lung health, nutrition, treatments).Data regarding changes in knowledge (using KDM-CF), from baseline to end of study visit, will be analyzed using Wilcoxon Signed Rank test. Data regarding changes in knowledge (using KDM-CF and CF-MQ) between groups (Intervention vs. Control) will be analyzed using Wilcoxon Rank Sum test.
  • change in CF Medication Belief Questionnaire (CF-MBQ) scores [ Time Frame: Day 1 to approximately week 24 ]
    Developed and validated to measure impact of interventions on specific social cognitive beliefs. Data regarding perception of medications (using CF-MBQ), from baseline to end of study, will be analyzed using Wilcoxon Signed Rank test. Data regarding perception of medications (using CF-MBQ), between groups (Intervention vs. Control), will be analyzed using Wilcoxon Rank Sum test. The CF-MBQ has 60 questions. There are five domains for this measure: motivation, self-efficacy, perceived importance of medication, and decisional balance to take or miss medications. Questions related to self-efficacy, motivation and importance items use a scale from 1 to 10. Questions related to decisional balance use a scale based on a 1 to 5 scale. Scores for each subscale's items will be summed and divided by the number of items to produce an average score ranging from 1 to 10 (self-efficacy, motivation and importance) OR 1 to 5 (decisional balance).
  • Mean change in adherence [ Time Frame: Day 1 to approximately week 24 ]
    Assess the preliminary effect of MAP on medication adherence from data collected from AdhereTech pill bottles and eTrack nebulizers that will be scored as a 'per drug analysis' of adherence with a ratio of competed to total prescribed doses in the study period. A composite score will be determined based on prescribed medications and medication/doses taken.
  • change in CF Medication Questionnaire (CF-MQ) scores [ Time Frame: Day 1 to approximately week 24 ]
    Developed to assess Patient Participant knowledge about prescribed CF medications including purpose, dose, and administration. Question items will evaluate knowledge of medication purpose, administration, dose, and dosing frequency. Correct response for dose and dosing frequency will be based on each patient's prescribed regimen. Questions regarding medication purposes and appropriate administration each have 1 correct answer. Total score will be defined as proportion of correct items to total items asked. Each Patient Participant will only be asked about items that are associated with that Patient Participant's prescribed treatment plan. Total score for a Participant will not be calculated if greater than 20% of the items are missing responses.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of a Mobile Medication Plan Application in CF Patient Care
Official Title  ICMJE Feasibility of a Mobile Medication Plan Application in CF Patient Care
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Cystic Fibrosis
  • Cystic Fibrosis in Children
Intervention  ICMJE Behavioral: MedActionPlan®
web-based, mobile medication management application [MedActionPlan® (MAP)]
Other Name: MAP
Study Arms  ICMJE
  • Experimental: Interventional
    web-based, mobile medication management application [MedActionPlan® (MAP) and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
    Intervention: Behavioral: MedActionPlan®
  • No Intervention: Control
    usual care and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
  • Optional Extension
    web-based, mobile medication management application [MedActionPlan® (MAP)]
    Intervention: Behavioral: MedActionPlan®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2018)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jonathan Greenberg 617-355-3197 jonathan.greenberg@childrens.harvard.edu
Contact: Caroline Perlman 6179196652 caroline.perlman@childrens.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03637504
Other Study ID Numbers  ICMJE IRB-P00021541
STRC-102-17-01 ( Other Identifier: Success with Therapies Research Consortium )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gregory Sawicki, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE
  • University of Arizona
  • Johns Hopkins University
  • Cystic Fibrosis Foundation
Investigators  ICMJE
Principal Investigator: Hanna Phan University of Arizona
Principal Investigator: Cori Daines University of Arizona
PRS Account Boston Children’s Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP