Adherence to Airway Clearance. Novel Approaches to Improving Adherence

NCT02906826 | Unknown

• 1 other identifier: UBColumbia
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Bronchiectasis

Keywords

Airway clearance technique; Positive expiratory pressure technique; Adherence

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Reported adherence

NO INTERVENTION

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.

Adherence with a video game

ACTIVE COMPARATOR

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

Interventions

Video game DEVICE

Video game operated by performing therapy correctly

Adherence with a video game

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6N3L3, Canada

RECRUITING

Related Publications (6)

• 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.

  PMID: 16679071 BACKGROUND

• 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.

  PMID: 7214782 BACKGROUND

• 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.

  PMID: 25233386 BACKGROUND

• 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.

  PMID: 23369661 BACKGROUND

• 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.

  PMID: 22856641 BACKGROUND

• 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.

  PMID: 9386661 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Bronchiectasis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases

Study Officials

• Maggie McIlwaine, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maggie P McIlwaine, PhD

CONTACT

604 875 2123; mmcilwaine@cw.bc.ca

Melissa Richmond, MPT.

CONTACT

604 875 2345; mrichmond@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 20, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)