Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT02906826

Conditions

Cystic Fibrosis

Bronchiectasis

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Interventions

Video game

Study Details

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

Study ID

NCT02906826

Start date

Aug, 2016

Status verified date

Sep, 2016

Completion date

Sep, 2017

Anticipated

Primary completion date

May, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Interventions and Outcome Measures

Arms

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

Interventions

Video game

Video game operated by performing therapy correctly

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Maggie P McIlwaine, PhD

604 875 2123mmcilwaine@cw.bc.ca

Melissa Richmond, MPT.

604 875 2345mrichmond@cw.bc.ca

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6N3L3

Contacts

Maggie McIlwaine, PhD

6048752123mmcilwaine@cw.bc.ca

Melissa Richmond, MPT

604 875 2345mrichmond@cw.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Sep 20, 2016

Last verified

Sep, 2016

Keywords

  • Airway clearance technique
  • Positive expiratory pressure technique
  • Adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2016-09-20.