NCT01964469

Brief 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. The Primary hypothesis: Health Outcome - The Breathe mobile health and web-based application improves asthma related quality of life more than conventional best practice

Trial Health

87
On Track

Trial Health Score

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

Enrollment
344

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable asthma

Geographic Reach
1 country

8 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

January 21, 2013

Last Update Submit

August 15, 2019

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Quality - Health Care Utilization

    1 year

Other Outcomes (2)

  • Health Outcome - Quality

    1 year

  • Health Outcome - Quality of Life

    6 months

Study Arms (3)

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.

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.

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.

Interventions

mobile & web-based action planBEHAVIORAL

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

Written self-management action planmobile & web based action plan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of asthma
  • Age 18 of age or older
  • Familiar with web technology
  • Provide consent
  • Understand/read/write English

You may not qualify if:

  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Amherstburg FHT

Amherstburg, Ontario, Canada

Location

Chatham-Kent FHT

Chatham, Ontario, Canada

Location

Harrow FHT

Harrow, Ontario, Canada

Location

Kingston Hospital Asthma Clinic

Kingston, Ontario, Canada

Location

Leamington FHT

Leamington, Ontario, N8H 1N8, Canada

Location

St. Joseph's Hospital Asthma Clinic

London, Ontario, Canada

Location

Sault St. Marie Group Health Centre

Sault Ste. Marie, Ontario, Canada

Location

Windsor FHT

Windsor, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30688654DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christopher Licskai

    Lawson Health Research Institution

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, University of Western Ontario

Study Record Dates

First Submitted

January 21, 2013

First Posted

October 17, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2014

Study Completion

March 1, 2016

Last Updated

August 19, 2019

Record last verified: 2019-08

Locations

CA(8)