Telemedicine Education for Caregivers and Asthma Control in Children (TCARE)

Effectiveness of Telemedicine-Based Education for Caregivers on Asthma Control in Children With Uncontrolled Asthma: A Randomized Controlled Trial

Asthma control in pediatric patients remains a critical issue for healthcare providers. Telemedicine has emerged as an effective solution for overcoming distance barriers in healthcare delivery. This study aims to utilize telemedicine-based education for caregivers to improve asthma control in children with uncontrolled asthma. By providing remote guidance and support, the study seeks to enhance caregivers' knowledge and management practices, ultimately leading to better asthma outcomes for pediatric patients.

Study Overview

• Status: Recruiting
• Conditions: Uncontrolled Asthma; Telemedicine-Based Education
• Intervention / Treatment: Other: Standard Care (in control arm); Other: Telemedicine-Based Education

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thang Hoang Le, MD; Phone Number: +84962024776; Email: hoangthang0899@gmail.com
• Study Contact Backup: Name: Ly Cong Tran, MD, MSc; Phone Number: +84397938208; Email: tcly@ctump.edu.vn

Study Locations

• Vietnam
  • Cần Thơ, Vietnam, 900000
    • Recruiting
    • Can Tho Children's Hospital
    • Contact: Nghia Quang Bui, MD, PhD; Phone Number: +84918398788; Email: bqnghia@ctump.edu.vn
    • Principal Investigator: Thang Hoang Le, MD
    • Principal Investigator: Ly Cong Tran, MD, MSc
    • Principal Investigator: Nghia Quang Bui, MD, PhD
    • Principal Investigator: My Hoang Le, MD, MSc
    • Sub-Investigator: Trinh Cam Truong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric asthma patients diagnosed according to the GINA guidelines, classified as having uncontrolled asthma, are managed and followed up for at least 1 month at the pediatric asthma unit of the outpatient department.

Exclusion Criteria:

• Pediatric patients who do not cooperate or are unable to complete the Childhood Asthma Control Test questionnaire.
• Caregivers who cannot complete the questionnaires related to the assessment of asthma control and associated factors.
• Pediatric patients who have siblings participating in the study.
• Patients currently participating in another clinical study (excluding non-interventional studies or registries).
• Failure to return for a second visit within 6 months following enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Standard care; The caregivers will receive a video call from the intervention researcher shortly for a health check and a reminder to follow the scheduled appointments.	Other: Standard Care (in control arm); Sham comparator through telemedicine
Experimental: Telemedicine; Caregivers in the intervention group will receive a video call from the intervention researcher within 15 minutes. The call will include education on avoiding factors related to uncontrolled asthma, reminders about treatment adherence, and following the scheduled appointments. Caregivers will be shown a visual demonstration of proper inhaler use, and they can ask questions about the video's practical steps at any time during the conversation. Additionally, questions about asthma management will be discussed, and tailored advice will be provided according to each child's condition.	Other: Telemedicine-Based Education; Intervention through telemedicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The improvement of asthma control	The patients will be evaluated for asthma control using the Childhood Asthma Control Test (C-ACT) for children aged 4-11 or Asthma Control Test (ACT) for children aged 12 and older. This evaluation will also be compared to the baseline to determine whether there is improvement after the intervention period.	At second follow-up visit (ranging from 4 to 24 weeks after enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The improvement of caregiver's knowledge regarding asthma control	The caregiver's knowledge regarding asthma will be assessed using a validated questionnaire. This evaluation will also be compared to the baseline to determine whether there is improvement after the intervention period.	At second follow-up visit (ranging from 4 to 24 weeks after enrollment)
The improvement of caregiver's attitudes toward asthma management	Caregiver's attitudes toward asthma management will be assessed using a set of questions designed to evaluate their perspectives on key aspects of asthma care, including the importance of regular doctor visits, adherence to controller medications, following prescription instructions, proper cleaning of inhaler devices, and mouth rinsing after inhaler use. The evaluation will be compared to baseline data to determine whether there is an improvement in caregivers' attitudes after the intervention period.	At second follow-up visit (ranging from 4 to 24 weeks after enrollment)
The improvement of proper inhaler technique usage	The patients will be evaluated on their proper inhaler use technique using a consistent checklist. This evaluation will be compared to the baseline to determine whether there is any improvement after the intervention period.	At second follow-up visit (ranging from 4 to 24 weeks after enrollment)

Collaborators and Investigators

• Sponsor: Can Tho University of Medicine and Pharmacy
• Investigators: Study Chair: Nghia Quang Bui, MD, PhD, Can Tho University of Medicine and Pharmacy; Study Director: Ly Cong Tran, MD, MSc, Can Tho University of Medicine and Pharmacy; Principal Investigator: Thang Hoang Le, MD, Can Tho University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: December 22, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Asthma; Pediatrics; Uncontrolled asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 2313/QD-DHYDCT; U1111-1317-1148 (Other Identifier: The Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Prohibited from regulations and contracts; Fear of inappropriate use of data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No