Cystic FibrosisNCT02906826
Adherence to Airway Clearance. Novel Approaches to Improving Adherence
A study testing Video game in people with Cystic Fibrosis and Bronchiectasis, run by University of British Columbia at 1 site in Canada.
Trial 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%. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cystic Fibrosis, Bronchiectasis
- What is being tested?
- Video game
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6N3L3
Maggie McIlwaine, PhD, 6048752123, mmcilwaine@cw.bc.ca
Melissa Richmond, MPT, 604 875 2345 ext. 7172, mrichmond@cw.bc.ca
About this study
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.
Read the 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:
- 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.
- Conditions
- Cystic Fibrosis, Bronchiectasis
- Being tested
- Video game
- Keywords
- Airway clearance technique, Positive expiratory pressure technique, Adherence
- Medical subject headings
- Cystic Fibrosis, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video gameDevice
Video game operated by performing therapy correctly
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Forced expiratory volume in one second is primary pulmonary function outcome to be measured as a secondary outcome.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maggie McIlwaine, University of British Columbia
- Investigators
- Maggie McIlwaine, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906826
- Sponsor's protocol ID
- UBColumbia
- Status last verified
- Sep 2016
- First submitted
- 26 Aug 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share data with individual participants,
Publications
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.
PubMed 16679071Passero 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.
PubMed 7214782O'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.
PubMed 25233386Ball 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.
PubMed 23369661McCormack 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.
PubMed 22856641McIlwaine 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.
PubMed 9386661
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Airway Clearance. Novel Approaches to Improving Adherence
- ClinicalTrials.gov ID
- NCT02906826
- Acronym / sponsor ID
- UBColumbia
- Conditions
- Cystic Fibrosis, Bronchiectasis
- Keywords
- Airway clearance technique, Positive expiratory pressure technique, Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Video gameDuring 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video gameVideo game operated by performing therapy correctly | Device | Adherence with a video game |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Background: PubMed 16679071Modi 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.
- Background: PubMed 7214782Passero 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.
- Background: PubMed 25233386O'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.
- Background: PubMed 23369661Ball 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.
- Background: PubMed 22856641McCormack 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.
- Background: PubMed 9386661McIlwaine 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.
- Individual participant dataSharing planned: No. There is no plan to share data with individual participants,
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie McIlwaine, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game in people with Cystic Fibrosis and Bronchiectasis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maggie P McIlwaine, PhD (604 875 2123, mmcilwaine@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906826, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.