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

July 2, 2025 updated by: Ly Cong Tran, Can Tho University of Medicine and Pharmacy

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Vietnam
      • Cần Thơ, Vietnam, 900000
        • Recruiting
        • Can Tho Children's Hospital
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At second follow-up visit (ranging from 4 to 24 weeks after enrollment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At second follow-up visit (ranging from 4 to 24 weeks after enrollment)
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.
At second follow-up visit (ranging from 4 to 24 weeks after enrollment)
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.
At second follow-up visit (ranging from 4 to 24 weeks after enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Can Tho University of Medicine and Pharmacy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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