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Clinical Trials/NCT06753214
NCT06753214RecruitingNot Applicable

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

Can Tho University of Medicine and Pharmacy1 site in 1 country64 target enrollmentStarted: June 5, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
64
Locations
1
Primary Endpoint
The improvement of asthma control

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
4 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Standard Care (in control arm) (Other)

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.

Intervention: Telemedicine-Based Education (Other)

Outcomes

Primary Outcomes

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

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ly Cong Tran

Lecturer

Can Tho University of Medicine and Pharmacy

Study Sites (1)

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