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Trial record 34 of 660 for:    applied AND web-

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

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Cystic Fibrosis in Children Behavioral: MedActionPlan® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of a Mobile Medication Plan Application in CF Patient Care
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Interventional
web-based, mobile medication management application [MedActionPlan® (MAP) and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
Behavioral: MedActionPlan®
web-based, mobile medication management application [MedActionPlan® (MAP)]
Other Name: MAP

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)]
Behavioral: MedActionPlan®
web-based, mobile medication management application [MedActionPlan® (MAP)]
Other Name: MAP




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637504


Contacts
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Contact: Jonathan Greenberg 617-355-3197 jonathan.greenberg@childrens.harvard.edu
Contact: Caroline Perlman 6179196652 caroline.perlman@childrens.harvard.edu

Locations
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United States, Alabama
Children's of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Principal Investigator: Gabriela Oates, PhD         
Sub-Investigator: Brad Troxler, MD         
United States, Arizona
University of Arizona and Banner Health Recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Hanna Phan, PharmD         
Sub-Investigator: Cori Daines, MD         
United States, California
Lucille Packard Children's Hospital Stanford Recruiting
Stanford, California, United States, 94304
Principal Investigator: Carlos Milla, MD         
Sub-Investigator: Diana Naranjo, PhD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Shruti Paranjape, MD         
Principal Investigator: Rebecca Dezube, MD         
Principal Investigator: Kristin Riekert, PhD         
United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14203
Principal Investigator: Carla Frederick, MD         
Principal Investigator: Danielle Goetz, MD         
Sponsors and Collaborators
Boston Children’s Hospital
University of Arizona
Johns Hopkins University
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Hanna Phan University of Arizona
Principal Investigator: Cori Daines University of Arizona

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Responsible Party: Gregory Sawicki, Co-Chair of Success with Therapies Research Consortium, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03637504     History of Changes
Other Study ID Numbers: IRB-P00021541
STRC-102-17-01 ( Other Identifier: Success with Therapies Research Consortium )
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Gregory Sawicki, Boston Children’s Hospital:
Feasibility
Mobile Medication Plan Application
Patient Care
Nebulized Medications
Oral Medications
MedActionPlan
eTrack Nebulizer
AdhereTech Pill Bottles

Additional relevant MeSH terms:
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Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases