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Trial record 39 of 4824 for:    British | Canada

Adherence to Airway Clearance. Novel Approaches to Improving Adherence

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ClinicalTrials.gov Identifier: NCT02906826
Recruitment Status : Unknown
Verified September 2016 by Maggie McIlwaine, University of British Columbia.
Recruitment status was:  Recruiting
First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Maggie McIlwaine, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Bronchiectasis Device: Video game Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Adherence to Airway Clearance. Novel Approaches to Improving Adherence
Study Start Date : August 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Reported adherence
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.
Active Comparator: Adherence with a video game
During the second 4 month period, participants will be given a video game on a tablet which is operated through the digital manometer by their performing their therapy correctly.Actual adherence will be measure again during this time and be compared to the no intervention arm
Device: Video game
Video game operated by performing therapy correctly




Primary Outcome Measures :
  1. Adherence to therapy [ Time Frame: Continually collected in real time commencing at enrollment to the study and finishing at completion of the study which is 8 months. ]
    Actual adherence will be measured using a digital device attached to the participants airway clearance device which uploads real time use to a database on the web.Thus this outcome is assessed on a continual basis throughout the 8 months of the study. No further data will be collected on adherence after the study is completed at 8 months.


Secondary Outcome Measures :
  1. Pulmonary function [ Time Frame: Pre and post each 4 month period beginning at time of enrollment and completing at end of study, approximately 8 months. There is no data collection post study following the end of the 8 month study period. ]
    Forced expiratory volume in one second is primary pulmonary function outcome to be measured as a secondary outcome.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02906826


Contacts
Contact: Maggie P McIlwaine, PhD 604 875 2123 mmcilwaine@cw.bc.ca
Contact: Melissa Richmond, MPT. 604 875 2345 ext 7172 mrichmond@cw.bc.ca

Locations
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6N3L3
Contact: Maggie McIlwaine, PhD    6048752123    mmcilwaine@cw.bc.ca   
Contact: Melissa Richmond, MPT    604 875 2345 ext 7172    mrichmond@cw.bc.ca   
Sub-Investigator: Mark Chilvers, MD         
Sub-Investigator: Nicole Lee Son, BSc         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Maggie McIlwaine, PhD University of British Columbia

Publications:
Responsible Party: Maggie McIlwaine, Clinical Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02906826     History of Changes
Other Study ID Numbers: UBColumbia
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data with individual participants,

Keywords provided by Maggie McIlwaine, University of British Columbia:
Airway clearance technique
Positive expiratory pressure technique
Adherence

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