Telemedicine Education for Caregivers and Asthma Control in Children

NCT06753214 | Recruiting

• 2 other identifiers: 2313/QD-DHYDCTU1111-1317-1148
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uncontrolled Asthma; Telemedicine-Based Education

Keywords

Asthma; Pediatrics; Telemedicine; Uncontrolled asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The improvement of caregiver's knowledge regarding asthma control

  At second follow-up visit (ranging from 4 to 24 weeks after enrollment)

• The improvement of caregiver's attitudes toward asthma management

  At second follow-up visit (ranging from 4 to 24 weeks after enrollment)

• The improvement of proper inhaler technique usage

  At second follow-up visit (ranging from 4 to 24 weeks after enrollment)

Study Arms (2)

Standard care

SHAM COMPARATOR

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)

Telemedicine

EXPERIMENTAL

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

Interventions

Telemedicine-Based Education OTHER

Intervention through telemedicine

Telemedicine

Standard Care (in control arm) OTHER

Sham comparator through telemedicine

Standard care

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho Children's Hospital

Can Tho, 900000, Vietnam

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Nghia Quang Bui, MD, PhD

  Can Tho University of Medicine and Pharmacy

  STUDY CHAIR

• Ly Cong Tran, MD, MSc

  Can Tho University of Medicine and Pharmacy

  STUDY DIRECTOR

• Thang Hoang Le, MD

  Can Tho University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thang Hoang Le, MD

CONTACT

+84962024776; hoangthang0899@gmail.com

Ly Cong Tran, MD, MSc

CONTACT

+84397938208; tcly@ctump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 31, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)