AzTrials
AzTrials

Cystic FibrosisMAPNCT03637504

Feasibility of a Mobile Medication Plan Application in CF Patient Care

A study testing MedActionPlan® in people with Cystic Fibrosis and Cystic Fibrosis in Children, run by Boston Children's Hospital at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Cystic Fibrosis, Cystic Fibrosis in Children
What is being tested?
MedActionPlan®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
5 sitesUnited States
Study dates
5 Sep 2018to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Children's of Alabama

    Birmingham, Alabama, 35233

  • University at Buffalo

    Buffalo, New York, 14203

  • Lucille Packard Children's Hospital Stanford

    Stanford, California, 94304

  • University of Arizona and Banner Health

    Tucson, Arizona, 85724

Other trials in United States

About this study

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.

Being tested
MedActionPlan®
Keywords
Feasibility, Mobile Medication Plan Application, Patient Care, Nebulized Medications, Oral Medications, MedActionPlan, eTrack Nebulizer, AdhereTech Pill Bottles
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MedActionPlan®Behavioural

    Also called MAP

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

Study groups in NCT03637504
Study groupRoleWhat they receive
InterventionalExperimentalweb-based, mobile medication management application [MedActionPlan® (MAP) and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
Receives: Behavioral: MedActionPlan®
ControlNo interventionusual care and continued use of eTrack nebulizer +/- AdhereTech pill bottles as measures of adherence
Optional ExtensionOtherweb-based, mobile medication management application [MedActionPlan® (MAP)]
Receives: Behavioral: MedActionPlan®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: week 24

  2. 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

    Measured: up to 30 months

Secondary outcomes (4)

  1. 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.

    Measured: Day 1 to approximately week 24

  2. 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).

    Measured: Day 1 to approximately week 24

  3. 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.

    Measured: Day 1 to approximately week 24

  4. 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.

    Measured: Day 1 to approximately week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2018
  2. Study start5 Sep 2018
  3. Primary completion31 Dec 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03637504
Sponsor's protocol ID
IRB-P00021541
Other IDs
STRC-102-17-01
Acronym
MAP
Status last verified
Aug 2021
First submitted
26 Jul 2018
Last updated
3 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MedActionPlan® in people with Cystic Fibrosis and Cystic Fibrosis in Children, run by Boston Children's Hospital at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean score of Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients assessed by likert scale (time frame: week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03637504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.

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