Back to resultsFeasibility of a Mobile Medication Plan Application in CF Patient Care (MAP)
Primary Purpose
Cystic Fibrosis, Cystic Fibrosis in Children
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MedActionPlan®
Sponsored by
About this trial
This is an interventional other trial for Cystic Fibrosis focused on measuring Feasibility, Mobile Medication Plan Application, Patient Care, Nebulized Medications, Oral Medications, MedActionPlan, eTrack Nebulizer, AdhereTech Pill Bottles
Eligibility Criteria
Inclusion Criteria:
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
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:
- 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)
1. Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in child's or own care
Sites / Locations
- Children's of Alabama
- University of Arizona and Banner Health
- Lucille Packard Children's Hospital Stanford
- Johns Hopkins University
- University at Buffalo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Other
Arm Label
Interventional
Control
Optional Extension
Arm Description
web-based, mobile medication management application [MedActionPlan® (MAP) and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
usual care and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
web-based, mobile medication management application [MedActionPlan® (MAP)]
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
change in Knowledge of Disease Management-CF questionnaire (KDM-CF) scores
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
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
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
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.
Full Information
NCT ID
NCT03637504
First Posted
July 26, 2018
Last Updated
August 2, 2021
Sponsor
Boston Children's Hospital
Collaborators
University of Arizona, Johns Hopkins University, Cystic Fibrosis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03637504
Brief Title
Feasibility of a Mobile Medication Plan Application in CF Patient Care
Acronym
MAP
Official Title
Feasibility of a Mobile Medication Plan Application in CF Patient Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
University of Arizona, Johns Hopkins University, Cystic Fibrosis Foundation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Cystic Fibrosis in Children
Keywords
Feasibility, Mobile Medication Plan Application, Patient Care, Nebulized Medications, Oral Medications, MedActionPlan, eTrack Nebulizer, AdhereTech Pill Bottles
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
web-based, mobile medication management application [MedActionPlan® (MAP) and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
Arm Title
Control
Arm Type
No Intervention
Arm Description
usual care and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
Arm Title
Optional Extension
Arm Type
Other
Arm Description
web-based, mobile medication management application [MedActionPlan® (MAP)]
Intervention Type
Behavioral
Intervention Name(s)
MedActionPlan®
Other Intervention Name(s)
MAP
Intervention Description
web-based, mobile medication management application [MedActionPlan® (MAP)]
Primary Outcome Measure Information:
Title
mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients assessed by likert scale
Description
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
Time Frame
week 24
Title
mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for clinicians assessed by likert scale
Description
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
Time Frame
up to 30 months
Secondary Outcome Measure Information:
Title
change in Knowledge of Disease Management-CF questionnaire (KDM-CF) scores
Description
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.
Time Frame
Day 1 to approximately week 24
Title
change in CF Medication Belief Questionnaire (CF-MBQ) scores
Description
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).
Time Frame
Day 1 to approximately week 24
Title
Mean change in adherence
Description
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.
Time Frame
Day 1 to approximately week 24
Title
change in CF Medication Questionnaire (CF-MQ) scores
Description
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.
Time Frame
Day 1 to approximately week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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:
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)
1. Previous use of MAP in the last 12 months - defined as use for 4 weeks or longer in child's or own care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Phan
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cori Daines
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Arizona and Banner Health
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Lucille Packard Children's Hospital Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of a Mobile Medication Plan Application in CF Patient Care
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