Asthma ExacerbationNCT05484037
Application of Telehealth Technology in Asthma Management
A study testing CANATEXTS in people with Asthma Exacerbation and Quality of Life, run by University of British Columbia at 3 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Asthma Exacerbation, Quality of Life, Medication Adherence
- What is being tested?
- CANATEXTS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Mar 2023to 30 May 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9
The Lung Centre, Vancouver Coastal Health, 7th Floor 2775 Laurel Street
Vancouver, British Columbia, V5Z 1M9
University of British Columbia - Vancouver Coastal Health
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: 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.
Read the detailed description
While effective treatment is available, asthma control is sub-optimal for 53% of Canadian patients, mainly due to a lack of adequate communication between the patient and care provider. This especially relates to adherence and inhaler technique. The standard of care for asthma is for a patient to see their physician at their office and ideally includes the physician and/or airways educator giving them an asthma action plan (AAP), normally in written format (wAAP), to help patients self-manage their asthma. The primary goal of wAAP is to facilitate a patient's response to worsening asthma symptoms. The wAAPs have shown to be effective in reducing asthma exacerbation; however, only approximately 50% of patients correctly adhere to it. Recently, Telehealth (TH) has been used to address asthma patients' self-efficacy, disease management, and health outcomes. Although there is increasing use of TH in respiratory medicine, in the absence of a robust evidence base it has been recommended conducting interventions to evaluate the efficacy of TH on asthma outcomes and especially exacerbation. We aim to use a TH technology in developing electronic asthma action plan (eAAP) and evaluate the effectiveness of a telecommunication intervention [(hereafter-called Canadian Asthma Text Messaging Study (CANATEXTS)] on improving asthma outcomes among adult asthma patients. The CANATEXTS intervention will digitalis a patient's wAAP to access and use online, will send patients a weekly text message reminders to complete their asthma diary and assess their level of asthma control. If the asthma control is sub-optimal, guided by their action plan, patients will adjust their therapy. The goal is to improve patient health outcomes via enhancing patient-physician interaction and using a more practical electronic asthma action plan model (eAAP). The Primary objective is to determine the effectiveness of CANATEXTS in reducing exacerbation over a 12-month period. The Secondary objectives are to determine the effectiveness of our intervention on quality of life and asthma control, and medication adherence. The cost-effectiveness of the CANATEXTS intervention for improving asthma outcomes when compared to standard care will also be assessed. Our previous TH feasibility study showed the efficacy of this intervention with asthma patients, in which 92% of participants showed a strong commitment to study completion. In our study, we found that the exacerbation rate was reduced by 18% in the intervention group (eAAP), when compared to the control group (wAAP). In the proposed CANATEXTS study, we endeavour to increase the precision of the intervention effect estimate (to 25%), improve accessibility and usability of CANATEXTS (e.g., engaged patients in the design of the intervention and incorporate their perspectives to improve the TH intervention), and include patients from across Canada. A well-known digital health platform that aims to deliver better care for all (call WelTel technology Platform) will be applied in the study, as it was applied in our feasibility study. We calculated a sample size of 622 asthma patients, which will be recruited from collaborating asthma clinics from multiple sites across Canada, predicting a 25% absolute reduction in exacerbation rates between the two study groups. The study participants will be randomly allocated to two study groups: (1) The intervention group will receive the standard care and have access to their AAP online (eAAP), while receiving weekly text messages (SMS) reminders to check-in their eAAP for 12 months for assessment of their asthma control. They will also be able to send and receive 2-way SMS for their non-emergency queries. (2) The control group will receive the standard care, have access to written-based AAP (wAAP), and education on how to use their wAAP. Both study groups will have access to self-management educational materials and will be treated according to the step-wise approach recommended in the Canadian Asthma Continuum. After subjects provide written informed consent, they will see a certified airways educator to receive an individualized action plan, an appropriate education on how to use their AAP, and will then meet the study coordinator to complete baseline questionnaires documenting their demographics, asthma history (including number of exacerbation within the past 12 months), current asthma control, and work productivity and activity impairment, as well as spirometry test (a pulmonary function test for measuring a patient's lung capacity and breath). We will also assess asthma quality of life, medication adherence, and asthma control using validated measurement tools. Furthermore, we will also assess how confident patients feel in controlling their asthma, using a measure of self-efficacy, attitudes, and knowledge. Study subjects will be seen at 6 and 12 months post initial assessment to assess their asthma control (specifically asthma exacerbation) and the use of health care resources. In addition, we will conduct telephone calls at 3 and 9 months post initial assessment to track health care utilization and exacerbation history. All outcomes of interest will be assessed during the three in-person assessments and the two telephone follow-up calls. A comparison of both groups on primary and secondary outcomes will be made at the end of the trial (month 12) to analyze data based on sex, age, disease severity, disease duration, and education level. Hypothesis: We expect to observe a significant reduction in asthma exacerbation rates among the intervention group (eAAP), when compared to the control group (wAAP). We further hypothesize that the eAAP subjects will have an improvement in secondary measures including quality of life, better asthma control and medication adherence. We believe the CANATEXTS intervention will work more effectively and yield better asthma outcomes in the intervention group, than it did in our feasibility study. We also believe that our proposed TH intervention will be more cost-effective when compared to standard care for asthma management in Canada.
- Conditions
- Asthma Exacerbation, Quality of Life, Medication Adherence
- Being tested
- CANATEXTS
- Keywords
- Telehealth, Asthma, Self-management, Asthma action plan, Text messaging, Asthma exacerbation, Randomized controlled, Cost-effectiveness
- Medical subject headings
- Medication Adherence, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANATEXTSOther
Also called Telehealth intervention
Canadian Asthma Text Messaging (CANATEXTS) is a TH intervention facilitating access to an electronic AAP (eAAP) via a mobile device.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Other: CANATEXTS |
| Control group | Active comparator | 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 Receives: Other: CANATEXTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation
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
Measured: Every 6 months up to one year
Secondary outcomes (2)
Asthma control
How well asthma is under control that will be measured using standard asthma control assessment
Measured: Every 6 months up to one year
Medication adherence
Adherence to prescribed medication by taking prescribed medication routinely. Will be measured using standard adherence checklist
Measured: every 6 months up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Mar 2023 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ExacerbationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Will be added later
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, Christopher Carlsten, University of British Columbia
- Investigators
- Chris Carlsten, M.D., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484037
- Sponsor's protocol ID
- H21-02767
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Tele-asthma Self-management Intervention, Canadian Asthma Text Messaging Study (CANATEXTS), Among Adults With Asthma
- ClinicalTrials.gov ID
- NCT05484037
- Acronym / sponsor ID
- H21-02767
- Conditions
- Asthma Exacerbation, Quality of Life, Medication Adherence
- Keywords
- Telehealth, Asthma, Self-management, Asthma action plan, Text messaging, Asthma exacerbation, Randomized controlled, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 2 Aug 2022 (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.
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.
Detailed description
While effective treatment is available, asthma control is sub-optimal for 53% of Canadian patients, mainly due to a lack of adequate communication between the patient and care provider. This especially relates to adherence and inhaler technique. The standard of care for asthma is for a patient to see their physician at their office and ideally includes the physician and/or airways educator giving them an asthma action plan (AAP), normally in written format (wAAP), to help patients self-manage their asthma. The primary goal of wAAP is to facilitate a patient's response to worsening asthma symptoms. The wAAPs have shown to be effective in reducing asthma exacerbation; however, only approximately 50% of patients correctly adhere to it. Recently, Telehealth (TH) has been used to address asthma patients' self-efficacy, disease management, and health outcomes. Although there is increasing use of TH in respiratory medicine, in the absence of a robust evidence base it has been recommended conducting interventions to evaluate the efficacy of TH on asthma outcomes and especially exacerbation. We aim to use a TH technology in developing electronic asthma action plan (eAAP) and evaluate the effectiveness of a telecommunication intervention [(hereafter-called Canadian Asthma Text Messaging Study (CANATEXTS)] on improving asthma outcomes among adult asthma patients. The CANATEXTS intervention will digitalis a patient's wAAP to access and use online, will send patients a weekly text message reminders to complete their asthma diary and assess their level of asthma control. If the asthma control is sub-optimal, guided by their action plan, patients will adjust their therapy. The goal is to improve patient health outcomes via enhancing patient-physician interaction and using a more practical electronic asthma action plan model (eAAP). The Primary objective is to determine the effectiveness of CANATEXTS in reducing exacerbation over a 12-month period. The Secondary objectives are to determine the effectiveness of our intervention on quality of life and asthma control, and medication adherence. The cost-effectiveness of the CANATEXTS intervention for improving asthma outcomes when compared to standard care will also be assessed. Our previous TH feasibility study showed the efficacy of this intervention with asthma patients, in which 92% of participants showed a strong commitment to study completion. In our study, we found that the exacerbation rate was reduced by 18% in the intervention group (eAAP), when compared to the control group (wAAP). In the proposed CANATEXTS study, we endeavour to increase the precision of the intervention effect estimate (to 25%), improve accessibility and usability of CANATEXTS (e.g., engaged patients in the design of the intervention and incorporate their perspectives to improve the TH intervention), and include patients from across Canada. A well-known digital health platform that aims to deliver better care for all (call WelTel technology Platform) will be applied in the study, as it was applied in our feasibility study. We calculated a sample size of 622 asthma patients, which will be recruited from collaborating asthma clinics from multiple sites across Canada, predicting a 25% absolute reduction in exacerbation rates between the two study groups. The study participants will be randomly allocated to two study groups: (1) The intervention group will receive the standard care and have access to their AAP online (eAAP), while receiving weekly text messages (SMS) reminders to check-in their eAAP for 12 months for assessment of their asthma control. They will also be able to send and receive 2-way SMS for their non-emergency queries. (2) The control group will receive the standard care, have access to written-based AAP (wAAP), and education on how to use their wAAP. Both study groups will have access to self-management educational materials and will be treated according to the step-wise approach recommended in the Canadian Asthma Continuum. After subjects provide written informed consent, they will see a certified airways educator to receive an individualized action plan, an appropriate education on how to use their AAP, and will then meet the study coordinator to complete baseline questionnaires documenting their demographics, asthma history (including number of exacerbation within the past 12 months), current asthma control, and work productivity and activity impairment, as well as spirometry test (a pulmonary function test for measuring a patient's lung capacity and breath). We will also assess asthma quality of life, medication adherence, and asthma control using validated measurement tools. Furthermore, we will also assess how confident patients feel in controlling their asthma, using a measure of self-efficacy, attitudes, and knowledge. Study subjects will be seen at 6 and 12 months post initial assessment to assess their asthma control (specifically asthma exacerbation) and the use of health care resources. In addition, we will conduct telephone calls at 3 and 9 months post initial assessment to track health care utilization and exacerbation history. All outcomes of interest will be assessed during the three in-person assessments and the two telephone follow-up calls. A comparison of both groups on primary and secondary outcomes will be made at the end of the trial (month 12) to analyze data based on sex, age, disease severity, disease duration, and education level. Hypothesis: We expect to observe a significant reduction in asthma exacerbation rates among the intervention group (eAAP), when compared to the control group (wAAP). We further hypothesize that the eAAP subjects will have an improvement in secondary measures including quality of life, better asthma control and medication adherence. We believe the CANATEXTS intervention will work more effectively and yield better asthma outcomes in the intervention group, than it did in our feasibility study. We also believe that our proposed TH intervention will be more cost-effective when compared to standard care for asthma management in Canada.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Will be added later
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: CANATEXTSIntervention 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 |
| Control group | Active comparator | Other: CANATEXTSControl 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 |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with chronic obstructive pulmonary disease (COPD)
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 |
|---|---|---|
| CANATEXTSAlso: Telehealth interventionCanadian Asthma Text Messaging (CANATEXTS) is a TH intervention facilitating access to an electronic AAP (eAAP) via a mobile device. | Other | Control group, Intervention group |
Primary outcome
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
2 secondary outcomes
Asthma control
Time frame: Every 6 months up to one year
Medication adherence
Time frame: every 6 months up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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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.
Chris Carlsten, M.D. principal investigator
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CANATEXTS in people with Asthma Exacerbation and Quality of Life, run by University of British Columbia at 3 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 6 inclusion and 1 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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Contact Iraj Poureslami, PhD (604-440-5191, iraj.poureslami@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbation (time frame: Every 6 months up to one year). 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 2 Aug 2022.