AsthmaeAMSNCT03193242
The Electronic Asthma Management System
A study testing Electronic Asthma Management System: eAMS in people with Asthma, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
This study is an extension of a pilot study in which investigators developed and tested a computerized tool to help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Electronic Asthma Management System: eAMS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Dec 2024to 1 Jun 2026
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible physicians will include all primary care physicians at the 4 sites.
- Eligible patients will include:
- patients with asthma, as determined by a validated electronic chart record search algorithm for asthma; patients >/= 16 years of age.
Who cannot join
- Patients who received an AAP within the last 6 months (from their primary care physician, a respirologist, or any other source).
- Pregnant patients will be excluded given that conventional AAP recommendations may not be appropriate in this population.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Wise Elephant Family Health Team
Brampton, Ontario, L6X 1N3
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: eAMS: The Electronic Asthma Management System
This study is an extension of a pilot study in which investigators developed and tested a computerized tool to help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the AAP, all based on patient responses to a questionnaire completed by patients on a tablet computer. In this phase patients will have the ability to complete the questionnaire on their smartphones, through a pre-downloaded app and will have access to an electronic asthma self-management app.
Read the detailed description
Asthma is a common and potentially fatal chronic disease. An asthma action plan (AAP) is a written plan produced by a physician for a patient with asthma, to provide education and guidelines for self-management of worsening asthma symptoms. Studies have shown that AAPs effectively improve asthma control, but physicians fail to provide AAPs due to lack of time and adequate skills. Physicians also often fail to determine if their patients have good asthma control, and to adjust medications in response to patients' control level.
In a pilot study investigators developed and tested a computerized tool to help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the AAP, all based on patient responses to a questionnaire completed by patients on a tablet computer. In the pilot, investigators found that the tablet computers add a level of complexity to clinic flow. In this study patients will have the ability to complete the questionnaire on their smartphones, through a pre-downloaded app. Patients will also have access to an electronic asthma self-management tool called Breathe through which they can view their AAP and other asthma educational information.
The investigators hope that this system will eliminate the barriers that physicians face in determining asthma control, adjusting medications, and delivering an AAP, and will increase the frequency with which physicians are able to achieve these goals in patients with asthma. The objectives of the study are to determine the impact of this system on asthma action plan delivery by primary care physicians, the frequency of checking control level, and the frequency and appropriateness of asthma medication changes (in accordance with control). The investigators will also attempt to determine the impact of the system on hospitalisations, emergency room (ER) visits, unscheduled visits to the doctor, total visits to the doctor, days off work or school, nocturnal asthma symptoms, daytime asthma symptoms, daytime rescue puffer use, and quality of life, and to measure physicians' perceptions of and satisfaction with the system.
- Conditions
- Asthma
- Being tested
- Electronic Asthma Management System: eAMS
- Keywords
- Asthma, Asthma 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.
Electronic Asthma Management System: eAMSOther
Electronic Asthma Management System: eAMS Intervention
eAMS consists of simple questionnaire completed either through an app on a patient's smartphone or tablet computer, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and a printable asthma action plan that is given to patients. eAMS will also provide access to a patient-oriented asthma management tool called Breathe.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Electronic Asthma Management System: eAMS Intervention
eAMS consists of simple questionnaire completed either through an app on a patient's smartphone or tablet computer, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and a printable asthma action plan that is given to patients. eAMS will also provide access to a patient-oriented asthma management tool called Breathe. Receives: Other: Electronic Asthma Management System: eAMS |
| Control | No intervention | Electronic Asthma Management System: eAMS - Control At control sites, eligible clinicians will be offered access to the web-based clinician-oriented asthma action plan (AAP) educational module produced by the Lung Association, copies of the Canadian Asthma Guidelines, and standard fillable paper-based AAPs (the eAMS will be offered after study end). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Received AAP
The study's primary outcome will be the proportion of patients currently on a controller medication who received an AAP in the intervention sites compared to the control sites, over 1 year (as determined through an electronic chart review).
Measured: 12 Months
Secondary outcomes (9)
Documented Asthma Control
The proportion of eligible patients who had asthma control documented
Measured: 12 months
Any Medication Change
The proportion of eligible patients who had a medication change made
Measured: 12 months
Appropriate Medication Change
The proportion of eligible patients who had an appropriate medication change made (based on asthma control, where ascertainable)
Measured: 12 months
Healthcare utilization rate
Secondary outcomes collected through patient questionnaire will measure healthcare utilization.
Measured: 12 months
Quality of life
Secondary outcomes collected through patient questionnaires will measure quality of life.
Measured: 12 months
Health Care Utilization
Health care utilization will also be validated through linkage with health administrative databases.
Measured: 12 months
System Use
Quantitative assessment of system use
Measured: 12 months
System usability
Specific questionnaire to collect data on tool usability.
Measured: First 6 months of intervention
Tool learnability
Focus group/interview to collect qualitative data on tool usability
Measured: First 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Lung Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193242
- Sponsor's protocol ID
- 10-052A
- Acronym
- eAMS
- Status last verified
- May 2023
- First submitted
- 9 May 2017
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eAMS: The Electronic Asthma Management System
- ClinicalTrials.gov ID
- NCT03193242
- Acronym / sponsor ID
- eAMS / 10-052A
- Conditions
- Asthma
- Keywords
- Asthma, Asthma Action Plan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Ontario Lung Association
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 20 Jun 2017 (actual)
- 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 an extension of a pilot study in which investigators developed and tested a computerized tool to help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the AAP, all based on patient responses to a questionnaire completed by patients on a tablet computer. In this phase patients will have the ability to complete the questionnaire on their smartphones, through a pre-downloaded app and will have access to an electronic asthma self-management app.
Detailed description
Asthma is a common and potentially fatal chronic disease. An asthma action plan (AAP) is a written plan produced by a physician for a patient with asthma, to provide education and guidelines for self-management of worsening asthma symptoms. Studies have shown that AAPs effectively improve asthma control, but physicians fail to provide AAPs due to lack of time and adequate skills. Physicians also often fail to determine if their patients have good asthma control, and to adjust medications in response to patients' control level.
In a pilot study investigators developed and tested a computerized tool to help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the AAP, all based on patient responses to a questionnaire completed by patients on a tablet computer. In the pilot, investigators found that the tablet computers add a level of complexity to clinic flow. In this study patients will have the ability to complete the questionnaire on their smartphones, through a pre-downloaded app. Patients will also have access to an electronic asthma self-management tool called Breathe through which they can view their AAP and other asthma educational information.
The investigators hope that this system will eliminate the barriers that physicians face in determining asthma control, adjusting medications, and delivering an AAP, and will increase the frequency with which physicians are able to achieve these goals in patients with asthma. The objectives of the study are to determine the impact of this system on asthma action plan delivery by primary care physicians, the frequency of checking control level, and the frequency and appropriateness of asthma medication changes (in accordance with control). The investigators will also attempt to determine the impact of the system on hospitalisations, emergency room (ER) visits, unscheduled visits to the doctor, total visits to the doctor, days off work or school, nocturnal asthma symptoms, daytime asthma symptoms, daytime rescue puffer use, and quality of life, and to measure physicians' perceptions of and satisfaction with the system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Electronic Asthma Management System: eAMSElectronic Asthma Management System: eAMS Intervention eAMS consists of simple questionnaire completed either through an app on a patient's smartphone or tablet computer, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and a printable asthma action plan that is given to patients. eAMS will also provide access to a patient-oriented asthma management tool called Breathe. |
| Control | No intervention | –Electronic Asthma Management System: eAMS - Control At control sites, eligible clinicians will be offered access to the web-based clinician-oriented asthma action plan (AAP) educational module produced by the Lung Association, copies of the Canadian Asthma Guidelines, and standard fillable paper-based AAPs (the eAMS will be offered after study end). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible physicians will include all primary care physicians at the 4 sites.
- Eligible patients will include:
- patients with asthma, as determined by a validated electronic chart record search algorithm for asthma; patients >/= 16 years of age.
Key exclusion criteria (2 listed)
- Patients who received an AAP within the last 6 months (from their primary care physician, a respirologist, or any other source).
- Pregnant patients will be excluded given that conventional AAP recommendations may not be appropriate in this population.
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 |
|---|---|---|
| Electronic Asthma Management System: eAMSElectronic Asthma Management System: eAMS Intervention eAMS consists of simple questionnaire completed either through an app on a patient's smartphone or tablet computer, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and a printable asthma action plan that is given to patients. eAMS will also provide access to a patient-oriented asthma management tool called Breathe. | Other | Intervention |
Primary outcome
Proportion of Received AAP
Time frame: 12 Months
The study's primary outcome will be the proportion of patients currently on a controller medication who received an AAP in the intervention sites compared to the control sites, over 1 year (as determined through an electronic chart review).
9 secondary outcomes
Documented Asthma Control
Time frame: 12 months
Any Medication Change
Time frame: 12 months
Appropriate Medication Change
Time frame: 12 months
Healthcare utilization rate
Time frame: 12 months
Quality of life
Time frame: 12 months
Health Care Utilization
Time frame: 12 months
System Use
Time frame: 12 months
System usability
Time frame: First 6 months of intervention
Tool learnability
Time frame: First 6 months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Asthma Management System: eAMS in people with Asthma, run by Unity Health Toronto at 2 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 3 inclusion and 2 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
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?
Proportion of Received AAP (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.