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Recruiting

NCT Number: NCT06753214

Telemedicine Education for Caregivers and Asthma Control in Children

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.

Recruiting

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Key information

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Tho Children's Hospital

Can Tho, 900000, Vietnam

Location status: Recruiting

Location contact

Ly Cong Tran, MD, MSc

PRINCIPAL_INVESTIGATOR

My Hoang Le, MD, MSc

PRINCIPAL_INVESTIGATOR

Nghia Quang Bui, MD, PhD

CONTACT

[email protected]

+84918398788

Nghia Quang Bui, MD, PhD

PRINCIPAL_INVESTIGATOR

Thang Hoang Le, MD

PRINCIPAL_INVESTIGATOR

Trinh Cam Truong, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine-Based Education

Other

Intervention through telemedicine

Standard Care (in control arm)

Other

Sham comparator through telemedicine

Primary outcomes

  1. The improvement of asthma control

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

    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.

Secondary outcomes

  1. The improvement of caregiver's knowledge regarding asthma control

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

    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.

  2. The improvement of caregiver's attitudes toward asthma management

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

    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.

  3. The improvement of proper inhaler technique usage

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ly Cong Tran, MD, MSc

CONTACT

[email protected]

+84397938208

Thang Hoang Le, MD

CONTACT

[email protected]

+84962024776

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Acronym: TCARE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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