Adherence to Airway Clearance. Novel Approaches to Improving Adherence

NCT ID: NCT02906826

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-09-30

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.

Conditions

Cystic Fibrosis; Bronchiectasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Video game

Intervention Type: DEVICE

Video game operated by performing therapy correctly

Interventions

Video game

Video game operated by performing therapy correctly

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Maggie McIlwaine

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maggie McIlwaine, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Maggie P McIlwaine, PhD

Role: CONTACT

mmcilwaine@cw.bc.ca

604 875 2123

Melissa Richmond, MPT.

Role: CONTACT

mrichmond@cw.bc.ca

604 875 2345 ext. 7172

Facility Contacts

Maggie McIlwaine, PhD

Role: primary

mmcilwaine@cw.bc.ca

6048752123

Melissa Richmond, MPT

Role: backup

mrichmond@cw.bc.ca

604 875 2345 ext. 7172

References

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.

Reference Type: BACKGROUND

PMID: 16679071 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7214782 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25233386 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23369661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22856641 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9386661 (View on PubMed)

Other Identifiers

UBColumbia

Identifier Type: -

Identifier Source: org_study_id