- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03637504
Feasibility of a Mobile Medication Plan Application in CF Patient Care (MAP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Children's of Alabama
-
-
Arizona
-
Tucson, Arizona, United States, 85724
- University of Arizona and Banner Health
-
-
California
-
Stanford, California, United States, 94304
- Lucille Packard Children's Hospital Stanford
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
-
New York
-
Buffalo, New York, United States, 14203
- University at Buffalo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
web-based, mobile medication management application [MedActionPlan® (MAP)]
Other Names:
|
No Intervention: Control
usual care and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
|
|
Other: Optional Extension
web-based, mobile medication management application [MedActionPlan® (MAP)]
|
web-based, mobile medication management application [MedActionPlan® (MAP)]
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
week 24
|
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
|
up to 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1 to approximately week 24
|
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).
|
Day 1 to approximately week 24
|
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.
|
Day 1 to approximately week 24
|
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.
|
Day 1 to approximately week 24
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hanna Phan, University of Michigan
- Principal Investigator: Cori Daines, University of Arizona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00021541
- STRC-102-17-01 (Other Identifier: Success with Therapies Research Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystic Fibrosis
-
Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
-
University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Royal College of Surgeons, IrelandThe Hospital for Sick Children; Imperial College London; Erasmus Medical Center; University College Dublin and other collaboratorsActive, not recruitingCystic Fibrosis | Adherence, Medication | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in Children | Cystic Fibrosis Liver DiseaseUnited Kingdom, Ireland
-
Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
-
The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University Hospital, BordeauxCompleted
-
University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
Clinical Trials on MedActionPlan®
-
Dong-A ST Co., Ltd.CompletedFunctional DyspepsiaKorea, Republic of
-
Galderma R&DCompletedAtopic DermatitisPhilippines, China
-
Chong Kun Dang PharmaceuticalCompleted
-
Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Diphtheria | PolioUnited States
-
Chung-Ang University Hosptial, Chung-Ang University...UnknownFunctional DyspepsiaKorea, Republic of
-
Amir AzarpazhoohInstitut Straumann AGCompletedPeriodontal Inflammation | Crown LengtheningCanada
-
Novartis PharmaceuticalsCompletedPulmonary Disease, Chronic Obstructive (COPD)Argentina
-
GuerbetCompletedPrimary Brain TumorColombia, Korea, Republic of, United States, Mexico
-
Sanofi Pasteur, a Sanofi CompanyCompletedPertussisUnited States