NCT03193242

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
1mo left

Started Dec 2024

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Dec 2024Jun 2026

First Submitted

Initial submission to the registry

May 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
7.5 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 9, 2017

Last Update Submit

May 9, 2023

Conditions

Keywords

AsthmaAsthma Action Plan

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Documented Asthma Control

    12 months

  • Any Medication Change

    12 months

  • Appropriate Medication Change

    12 months

  • Healthcare utilization rate

    12 months

  • Quality of life

    12 months

  • +4 more secondary outcomes

Study Arms (2)

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.

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).

Interventions

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.

Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wise Elephant Family Health Team

Brampton, Ontario, L6X 1N3, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

June 20, 2017

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations