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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03193242
Other study ID # 10-052A
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2024
Est. completion date June 1, 2026

Study information

Verified date May 2023
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 1, 2026
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electronic Asthma Management System: eAMS
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.

Locations

Country Name City State
Canada Wise Elephant Family Health Team Brampton Ontario
Canada St. Michael's Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Unity Health Toronto Ontario Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 12 Months
Secondary Documented Asthma Control The proportion of eligible patients who had asthma control documented 12 months
Secondary Any Medication Change The proportion of eligible patients who had a medication change made 12 months
Secondary Appropriate Medication Change The proportion of eligible patients who had an appropriate medication change made (based on asthma control, where ascertainable) 12 months
Secondary Healthcare utilization rate Secondary outcomes collected through patient questionnaire will measure healthcare utilization. 12 months
Secondary Quality of life Secondary outcomes collected through patient questionnaires will measure quality of life. 12 months
Secondary Health Care Utilization Health care utilization will also be validated through linkage with health administrative databases. 12 months
Secondary System Use Quantitative assessment of system use 12 months
Secondary System usability Specific questionnaire to collect data on tool usability. First 6 months of intervention
Secondary Tool learnability Focus group/interview to collect qualitative data on tool usability First 6 months of intervention
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