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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Iraj Poureslami, PhD contact

604-440-5191

iraj.poureslami@ubc.ca

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

Other trials in Canada

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.

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 groups in NCT05484037
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention 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 groupActive comparatorControl 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted2 Aug 2022
  2. Study start1 Mar 2023 (estimated)
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion30 May 2026 (estimated)

Resources

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)
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

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.

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