AsthmaASMANCT01964469
Consumer Access to Personal Health Information for Asthma Self-Management
A study testing mobile & web-based action plan in people with Asthma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 8 sites in Canada.
Trial summary
This study is to compare Smart phone mobile device and/or web based application asthma action plan to the standard of care paper based asthma action plan within an asthma program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- mobile & web-based action plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 8 sitesCanada
- Study dates
- Feb 2013to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of asthma
- Age 18 of age or older
- Familiar with web technology
- Provide consent
- Understand/read/write English
Who cannot join
- Indication of other chronic lung diseases in the opinion of the physician that would impact their ability to participate in the trial or affect quality of life (Cystic Fibrosis, Chronic Obstructive Pulmonary Disease, Bronchiectasis)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Amherstburg FHT
Amherstburg, Ontario
Chatham-Kent FHT
Chatham, Ontario
Harrow FHT
Harrow, Ontario
Kingston Hospital Asthma Clinic
Kingston, Ontario
Leamington FHT
Leamington, Ontario, N8H 1N8
St. Joseph's Hospital Asthma Clinic
London, Ontario
Sault St. Marie Group Health Centre
Sault Ste. Marie, Ontario
Windsor FHT
Windsor, Ontario
About this study
Official title: Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)
This study is to compare Smart phone mobile device and/or web based application asthma action plan to the standard of care paper based asthma action plan within an asthma program. The Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice
Read the detailed description
This study is a multi-centre, randomized controlled trial comparing a web-based (Smart phone mobile device, tablet and/or personal computer PC) asthma action plan application to best practice/usual care within an asthma program. A third external comparator arm will compare participants to all patients with asthma in Ontario using data obtained from the Ontario Asthma Surveillance Information System (OASIS) cohort, created from administrative data sets within the Institute for Clinical Evaluative Sciences (ICES). Subjects will be randomly assigned in blocks of four, stratified by site to, in a ratio of 1:1 intervention or control arms. The study will enrol approximately 400 patients in total at all study sites.
- Conditions
- Asthma
- Being tested
- mobile & web-based action plan
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile & web-based action planBehavioural
Evidence-based best practice primary care asthma program including asthma self-management education replacing the written self-management action plan with the Breathe mobile health and web-based application
| Study group | Role | What they receive |
|---|---|---|
| Written self-management action plan | Placebo comparator | Usual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review. Receives: Behavioral: mobile & web-based action plan |
| mobile & web based action plan | Experimental | Evidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application. Receives: Behavioral: mobile & web-based action plan |
| Administrative data set | No intervention | Health services use will be evaluated comparatively against our intervention population and our control and we will include health services utilization data from one year prior randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Outcome - Quality of Life
Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice.
Measured: 6 months
Secondary outcomes (1)
Quality - Health Care Utilization
Appropriateness of Care - Individuals with asthma who use the intervention will experience a decrease in the number of unplanned health system encounters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Lung Association, Ontario Ministry of Health and Long Term Care, TELUS, Canada Health Infoway
- Responsible party
- Principal investigator, Chris Licskai, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Christopher Licskai, Principal investigator, Lawson Health Research Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964469
- Sponsor's protocol ID
- 00000940
- Acronym
- ASMA
- Status last verified
- Aug 2019
- First submitted
- 21 Jan 2013
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Morita PP, Yeung MS, Ferrone M, Taite AK, Madeley C, Stevens Lavigne A, To T, Lougheed MD, Gupta S, Day AG, Cafazzo JA, Licskai C. A Patient-Centered Mobile Health System That Supports Asthma Self-Management (breathe): Design, Development, and Utilization. JMIR Mhealth Uhealth. 2019 Jan 28;7(1):e10956. doi: 10.2196/10956.
PubMed 30688654
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer Access to Personal Health Information for Asthma Self-Management Phase 2 (Pilot Implementation)
- ClinicalTrials.gov ID
- NCT01964469
- Acronym / sponsor ID
- ASMA / 00000940
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Ontario Lung Association, Ontario Ministry of Health and Long Term Care, TELUS, Canada Health Infoway
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Oct 2013 (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.
This study is to compare Smart phone mobile device and/or web based application asthma action plan to the standard of care paper based asthma action plan within an asthma program. The Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice
Detailed description
This study is a multi-centre, randomized controlled trial comparing a web-based (Smart phone mobile device, tablet and/or personal computer PC) asthma action plan application to best practice/usual care within an asthma program. A third external comparator arm will compare participants to all patients with asthma in Ontario using data obtained from the Ontario Asthma Surveillance Information System (OASIS) cohort, created from administrative data sets within the Institute for Clinical Evaluative Sciences (ICES). Subjects will be randomly assigned in blocks of four, stratified by site to, in a ratio of 1:1 intervention or control arms. The study will enrol approximately 400 patients in total at all study sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Written self-management action plan | Placebo comparator | Behavioral: mobile & web-based action planUsual Care: Evidence-based best practice within the primary care asthma program including written self-management action plan and regular clinical review. |
| mobile & web based action plan | Experimental | Behavioral: mobile & web-based action planEvidence-based best practice within the primary care asthma program, replacing the written action plan with the Breathe mobile health and web-based application. |
| Administrative data set | No intervention | –Health services use will be evaluated comparatively against our intervention population and our control and we will include health services utilization data from one year prior randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of asthma
- Age 18 of age or older
- Familiar with web technology
- Provide consent
- Understand/read/write English
Key exclusion criteria (1 listed)
- Indication of other chronic lung diseases in the opinion of the physician that would impact their ability to participate in the trial or affect quality of life (Cystic Fibrosis, Chronic Obstructive Pulmonary Disease, Bronchiectasis)
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 |
|---|---|---|
| mobile & web-based action planEvidence-based best practice primary care asthma program including asthma self-management education replacing the written self-management action plan with the Breathe mobile health and web-based application | Behavioural | Written self-management action plan, mobile & web based action plan |
Primary outcome
Health Outcome - Quality of Life
Time frame: 6 months
Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice.
1 secondary outcome
Quality - Health Care Utilization
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Derived from this study: PubMed 30688654Morita PP, Yeung MS, Ferrone M, Taite AK, Madeley C, Stevens Lavigne A, To T, Lougheed MD, Gupta S, Day AG, Cafazzo JA, Licskai C. A Patient-Centered Mobile Health System That Supports Asthma Self-Management (breathe): Design, Development, and Utilization. JMIR Mhealth Uhealth. 2019 Jan 28;7(1):e10956. doi: 10.2196/10956.
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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.
Christopher Licskai principal investigator
Lawson Health Research Institution
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile & web-based action plan in people with Asthma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 8 sites 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 1 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: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Outcome - Quality of Life (time frame: 6 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 NCT01964469, which also lists 1 linked publication.
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 19 Aug 2019.