Application of Telehealth Technology in Asthma Management

NCT05484037 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2022-08-02

No results posted yet for this study

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

Interventions

OTHER

CANATEXTS

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

Sponsors & Collaborators

  • Vancouver Coastal Health Research Institute

    collaborator OTHER
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Chris Carlsten, M.D. · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2026-02-28
Completion
2026-05-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484037 on ClinicalTrials.gov