Application of Telehealth Technology in Asthma Management

NCT05484037 | Not Yet Recruiting DMC

• 1 other identifier: H21-02767
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Asthma Exacerbation; Quality of Life; Medication Adherence

Keywords

Telehealth; Asthma; Self-management; Asthma action plan; Text messaging; Asthma exacerbation; Randomized controlled; Cost-effectiveness

Outcome Measures

Primary Outcomes (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

  Every 6 months up to one year

Secondary Outcomes (2)

• Asthma control

  Every 6 months up to one year

• Medication adherence

  every 6 months up to one year

Other Outcomes (1)

• Cost effectiveness

  at the end of year 3 through year four of the intervention

Study Arms (2)

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

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

Other: CANATEXTS

Interventions

CANATEXTS OTHER

Canadian Asthma Text Messaging (CANATEXTS) is a TH intervention facilitating access to an electronic AAP (eAAP) via a mobile device.

Also known as: Telehealth intervention

Control group; Intervention group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Gender Eligibility Details: Yes, based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Patients with chronic obstructive pulmonary disease (COPD)

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health Research Institute: collaborator

Study Sites (3)

Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute

Vancouver, British Columbia, V5Z 1M9, Canada

Location

The Lung Centre, Vancouver Coastal Health, 7th Floor 2775 Laurel Street

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University of British Columbia - Vancouver Coastal Health

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Medication Adherence; Asthma

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Chris Carlsten, M.D.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iraj Poureslami, PhD

CONTACT

604-440-5191; iraj.poureslami@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research coordinator (RC) and certified respiratory educators (CRE) are unblinded. The main investigator and an independent clinical coordinator will be blinded and collected data for primary and secondary outcomes. Statistician and economic evaluator will be blinded to the study randomized orientation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Will be added later

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 2, 2022
• Study Start: March 1, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

CA (3)