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
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Bronchiectasis||Device: Video game||Not Applicable|
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.
- To objectively measure adherence, using an electronic manometer attached to a PEP mask, against reported adherence.
- 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|
|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|
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
- 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.
- 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.
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
|Contact: Maggie P McIlwaine, PhD||604 875 firstname.lastname@example.org|
|Contact: Melissa Richmond, MPT.||604 875 2345 ext email@example.com|
|Canada, British Columbia|
|University of British Columbia||Recruiting|
|Vancouver, British Columbia, Canada, V6N3L3|
|Contact: Maggie McIlwaine, PhD 6048752123 firstname.lastname@example.org|
|Contact: Melissa Richmond, MPT 604 875 2345 ext 7172 email@example.com|
|Sub-Investigator: Mark Chilvers, MD|
|Sub-Investigator: Nicole Lee Son, BSc|
|Principal Investigator:||Maggie McIlwaine, PhD||University of British Columbia|