- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05484037
Application of Telehealth Technology in Asthma Management
Evaluating a Tele-asthma Self-management Intervention, Canadian Asthma Text Messaging Study (CANATEXTS), Among Adults With Asthma
Background: While effective treatments are available, asthma control is sub-optimal for many asthma patients. To help patients self-manage their asthma symptoms, provision of an asthma action plan (AAP) in written format (wAAP), with instructions on managing worsening asthma symptoms is recommended, as a standard of care; however, only about half of patients correctly adhere to their AAP. Canadian Asthma Text Messaging Study (CANATEXTS) is a Telehealth (TH) intervention facilitating access to an electronic AAP (eAAP) via a mobile device. In a feasibility study to assess the safety and efficacy of CANATEXTS, an 18% reduction in the relative risk of exacerbation was observed among the intervention group compared to control group. This study will assess the effectiveness of CANATEXTS on asthma outcomes in a Canada-wide study.
Methods: This is a superiority a 2-arm, multi-site randomized control trial (RCT). This study aims to determine if CANATEXTS reduces asthma exacerbation over a 12-month period, improves asthma control, quality of life (QoL) and medication adherence, and is cost-effective. The intervention includes access to an electronic asthma action plan (eAAP) on patients' mobile devices, disease-related education, and weekly reminders via a Short messaging system (SMS) interface. The study will include 620 adult participants with asthma recruited from 14 respiratory clinics across Canada. Participants will be randomly assigned to either Intervention group (eAAP) or Control groups (wAAP). All outcomes of interest will be assessed during three in-person assessments (baseline, 6-month, and 12-month) and two telephone follow-ups (3-month and 9-month). Data will be analyzed with a linear mixed-effects model across all time points. Discussion: TH has the potential to improve adult individuals with asthma's engagement in self-management practices. Our feasibility study showed TH could yield a reduction in asthma exacerbation. If the proposed TH intervention is found to be effective for asthma management in a nation-wide trial, it will generate evidence to support integration of TH in asthma self-management. This study will also provide important information on the cost-effectiveness of CANATEXTS when compared to standard asthma care.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iraj Poureslami, PhD
- Phone Number: 604-440-5191
- Email: iraj.poureslami@ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- The Lung Centre, Vancouver Coastal Health, 7th Floor 2775 Laurel Street
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Vancouver, British Columbia, Canada, V5Z 1M9
- Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute
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Vancouver, British Columbia, Canada, V5Z 1M9
- University of British Columbia - Vancouver Coastal Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis asthma
- Must have history of one exacerbation in the previous year
- Must have moderate or severe asthma
- Must be prescribed both reliever and controller medications
- Must be capable to communicate in English or French
- Mush have a digital device with access to the internet
Exclusion Criteria:
- Patients with chronic obstructive pulmonary disease (COPD)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
Intervention group/telehealth Arm: will be provided access to their electronic asthma action plan (eAAP) via a web Uniform Resource Locator (URL), receive weekly short message service (SMS) check-ins for one year, and be able to communicate with the site's research coordinator (RC) and Certified Respiratory Educator (CRE) via an integrated and interactive (two-way) SMS feature to manage their asthma
|
Canadian Asthma Text Messaging (CANATEXTS) is a TH intervention facilitating access to an electronic AAP (eAAP) via a mobile device.
Other Names:
|
ACTIVE_COMPARATOR: Control group
Control group/standard care Arm: will receive their written Asthma Action Plan (wAAP) and information on how to use it by the site's Certified Respiratory Educator to manage their asthma
|
Canadian Asthma Text Messaging (CANATEXTS) is a TH intervention facilitating access to an electronic AAP (eAAP) via a mobile device.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exacerbation
Time Frame: Every 6 months up to one year
|
An asthma attack that requires either taking a course of Oral Corticosteroids (OCS) for at least three days, or an asthma-related emergency room (ED) visit or hospitalization
|
Every 6 months up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma control
Time Frame: Every 6 months up to one year
|
How well asthma is under control that will be measured using standard asthma control assessment
|
Every 6 months up to one year
|
Medication adherence
Time Frame: every 6 months up to one year
|
Adherence to prescribed medication by taking prescribed medication routinely.
Will be measured using standard adherence checklist
|
every 6 months up to one year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost effectiveness
Time Frame: at the end of year 3 through year four of the intervention
|
Trade-off between the incremental costs and incremental effectiveness of telehealth technology
|
at the end of year 3 through year four of the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chris Carlsten, M.D., University of British Columbia
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H21-02767
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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