Adherence to Airway Clearance. Novel Approaches to Improving Adherence

Brief Title

Adherence to Airway Clearance. Novel Approaches to Improving Adherence

Official Title

Adherence to Airway Clearance. Novel Approaches to Improving Adherence

Brief Summary

      An airway clearance technique (ACT) is one of the core treatments for children with chronic
      lung diseases who are unable to clear their secretions effectively. Unfortunately adherence
      to performing an ACT is low with a reported rate between 40 - 70%. Up to the present, there
      has been no way to objectively measure adherence to an ACT. With new technology, it is now
      feasible to connect an electronic manometer to an airway clearance device to objectively
      measure how often the child is actually performing their ACT. The first part of this proposed
      study is to objectively measure adherence against reported adherence over a 4 month period.
      During the second 4 months a video game will be added to the digital manometer which only
      operates if participants are performing their ACT properly. Adherence will again be measured.
    

Detailed Description

      Background:- Airway clearance using an airway clearance technique (ACT) is one of the core
      treatments for children with chronic lung diseases such as cystic fibrosis, periciliary
      dyskinesia, and non-CF bronchiectasis who are unable to clear their secretions effectively.
      One of the most frequently used ACTs is called positive expiratory pressure (PEP) which uses
      a mask to produce a back pressure in the lungs getting air behind the mucus to mobilize it up
      the airways. Unfortunately adherence to performing an ACT is low with a reported rate between
      40 - 70%. Up to the present, there has been no way to objectively measure adherence to an
      ACT. However, with new technology, it is now feasible to connect an electronic device to the
      PEP mask to objectively measure how often the child is actually performing their ACT. This
      proposed study would be the first study to objectively measure adherence against reported
      adherence.

      Purpose:

        1. To objectively measure adherence, using an electronic manometer attached to a PEP mask,
           against reported adherence.

        2. Secondly, to objectively measure adherence after connecting the electronic manometer to
           an age appropriate video game designed to operate only if the PEP mask is used properly.

      The hypothesis is that actual adherence is lower than reported adherence, and that by using a
      video game as a feedback mechanism while performing PEP, adherence will be improved.

      Methodology:-20 subjects with either a diagnosis of cystic fibrosis or non CF bronchiectasis,
      between the ages of 6 - 12 years old will be recruited into this study. Subjects will be
      their own control, in that their reported adherence will be measured against their actual
      adherence. After enrollment, subjects will be provided with an electronic device which
      connects to the pressure port of their PEP mask. They will be told that the device attached
      to the PEP Mask pressure port will measure pressure. Subjects will be asked to continue using
      their PEP Mask as prescribed for 4 months referred to as period one. During this time the
      electronic device will collect data on pressure and how often and when the PEP mask is used.
      In addition the subject or parent will be asked to keep a log book of when and how often they
      did their PEP Mask.

      At the end of 4 months, during a second 4 month period, the electronic manometer will be
      connected to software which will allow the subject to play video games operated by correct
      breathing through the PEP Mask. During this period actual adherence captured through the
      electronic device will be measured against reported adherence for this period and also to
      actual adherence measured during the first 4 month period.

      Primary outcome is rate of adherence to prescribed therapy, measured between reported and
      objectively measured adherence during the first 4 month period. During the second 4 month
      period, rate of adherence will be compared to rate of adherence during the first 4 month
      period. Secondary outcome is change in FEV1 from period one to period two. It is hoped that
      by using fun video games while performing airway clearance, adherence will be improved.
    

Study Type

Interventional

Primary Outcome

Adherence to therapy

Secondary Outcome

 Pulmonary function

Condition

Cystic Fibrosis

Intervention

Video game

Study Arms / Comparison Groups

 Reported adherence

Description:  During a 4 month period the investigators will measure adherence to therapy as reported in a daily diary by participants against actual adherence which will be measured by a digital manometer attached to the participants therapy device which uploads real time data to the cloud.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

20

Start Date

August 2016

Completion Date

September 2017

Primary Completion Date

May 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of Bronchiectasis either by chest-radiograph or a high resolution
             computerized tomography; or cystic fibrosis diagnosed by sweat test using a
             quantitative method or a genotype with two identifiable CF mutations.

          -  Age, between 6 - 12 years of age and be competent in spirometry.

          -  Have been using PEP Mask as their primary airway clearance technique for the previous
             3 months.

          -  Willingness to adhere to prescribed treatment regimen.

          -  Clinically stable with no evidence of a respiratory exacerbation within a month of
             enrollment as assessed by a site Physician.

        Exclusion Criteria:

          -  Diagnosis of Allergic Broncho-Pulmonary Aspergillosis, or a persistent culture for
             B.cepacia complex within the previous 1 year period.

          -  On active treatment for non-Tuberculous Mycobacterium

          -  Use of intravenous antibiotics within the previous 30 days of enrollment.

          -  Initiation and or change in maintenance therapy within 30 days of enrollment.

          -  Use of systemic corticosteroids (1mg/kg if < 20 kg or 20 mg of prednisone per day)
             within 14 days of enrollment.

          -  Concurrent participation in another study that could potentially affect the present
             study.

          -  Presence of a condition or abnormality that in the opinion of the site Physician would
             compromise the safety of the patient or the quality of the data.
      

Gender

All

Ages

6 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Maggie McIlwaine, PhD, 604 875 2123, [email protected]

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT02906826

Organization ID

UBColumbia

Responsible Party

Principal Investigator

Study Sponsor

University of British Columbia

Study Sponsor

Maggie McIlwaine, PhD, Principal Investigator, University of British Columbia

Verification Date

September 2016