NCT02906826|Unknown
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Sponsor study identifier
interventional
20
1 country
1
Study Start
August 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2016
Date type not reportedThis date has not been verified as actual or estimated.
August 26, 2016
Actual (reported)September 20, 2016
Actual (reported)May 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Adherence to therapy
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.
Continually collected in real time commencing at enrollment to the study and finishing at completion of the study which is 8 months.
Pulmonary function
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.
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.
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
Video game operated by performing therapy correctly
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of British Columbia
Vancouver, British Columbia, V6N3L3, Canada
Modi AC, Lim CS, Yu N, Geller D, Wagner MH, Quittner AL. A multi-method assessment of treatment adherence for children with cystic fibrosis. J Cyst Fibros. 2006 Aug;5(3):177-85. doi: 10.1016/j.jcf.2006.03.002. Epub 2006 May 5.
Passero MA, Remor B, Salomon J. Patient-reported compliance with cystic fibrosis therapy. Clin Pediatr (Phila). 1981 Apr;20(4):264-8. doi: 10.1177/000992288102000406.
O'Donohoe R, Fullen BM. Adherence of subjects with cystic fibrosis to their home program: a systematic review. Respir Care. 2014 Nov;59(11):1731-46. doi: 10.4187/respcare.02990. Epub 2014 Jul 15.
Maggie McIlwaine, PhD
University of British Columbia
First Submitted
August 26, 2016
First Posted
September 20, 2016
Study Start
August 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2017
Contact the study team to confirm eligibility.
Ball R, Southern KW, McCormack P, Duff AJ, Brownlee KG, McNamara PS. Adherence to nebulised therapies in adolescents with cystic fibrosis is best on week-days during school term-time. J Cyst Fibros. 2013 Sep;12(5):440-4. doi: 10.1016/j.jcf.2012.12.012. Epub 2013 Jan 29.
McCormack P, Southern KW, McNamara PS. New nebulizer technology to monitor adherence and nebulizer performance in cystic fibrosis. J Aerosol Med Pulm Drug Deliv. 2012 Dec;25(6):307-9. doi: 10.1089/jamp.2011.0934. Epub 2012 Aug 2.
McIlwaine PM, Wong LT, Peacock D, Davidson AG. Long-term comparative trial of conventional postural drainage and percussion versus positive expiratory pressure physiotherapy in the treatment of cystic fibrosis. J Pediatr. 1997 Oct;131(4):570-4. doi: 10.1016/s0022-3476(97)70064-7.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 20, 2016
Record last verified: 2016-09
There is no plan to share data with individual participants,
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Source: ClinicalTrials.gov.
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