Uncontrolled AsthmaTCARENCT06753214
Telemedicine Education for Caregivers and Asthma Control in Children
A study testing Telemedicine-Based Education in people with Uncontrolled Asthma and Telemedicine-Based Education, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Uncontrolled Asthma, Telemedicine-Based Education
- What is being tested?
- Telemedicine-Based Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteVietnam
- Study dates
- 5 Jun 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Can Tho Children's Hospital
Can Tho, 900000
Nghia Quang Bui, MD, PhD, +84918398788, bqnghia@ctump.edu.vn
Thang Hoang Le, MD
About this study
Official title: 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.
- Conditions
- Uncontrolled Asthma, Telemedicine-Based Education
- Being tested
- Telemedicine-Based Education, Standard Care (in control arm)
- Keywords
- Asthma, Pediatrics, Telemedicine, Uncontrolled asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-Based EducationOther
Intervention through telemedicine
Standard Care (in control arm)Other
Sham comparator through telemedicine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Telemedicine-Based Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: At second follow-up visit (ranging from 4 to 24 weeks after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start5 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ly Cong Tran, Can Tho University of Medicine and Pharmacy
- Investigators
- Nghia Quang Bui, MD, PhD, Study chair, Can Tho University of Medicine and PharmacyLy Cong Tran, MD, MSc, Study director, Can Tho University of Medicine and PharmacyThang Hoang Le, MD, Principal investigator, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753214
- Sponsor's protocol ID
- 2313/QD-DHYDCT
- Other IDs
- U1111-1317-1148
- Acronym
- TCARE
- Status last verified
- Jul 2025
- First submitted
- 22 Dec 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prohibited from regulations and contracts; Fear of inappropriate use of data
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telemedicine-Based Education for Caregivers on Asthma Control in Children With Uncontrolled Asthma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06753214
- Acronym / sponsor ID
- TCARE / 2313/QD-DHYDCT
- Conditions
- Uncontrolled Asthma, Telemedicine-Based Education
- Keywords
- Asthma, Pediatrics, Telemedicine, Uncontrolled asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Sham comparator | Other: Standard Care (in control arm)The caregivers will receive a video call from the intervention researcher shortly for a health check and a reminder to follow the scheduled appointments. |
| Telemedicine | Experimental | Other: Telemedicine-Based EducationCaregivers 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. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-Based EducationIntervention through telemedicine | Other | Telemedicine |
| Standard Care (in control arm)Sham comparator through telemedicine | Other | Standard care |
Primary outcome
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.
3 secondary outcomes
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 improvement of caregiver's attitudes toward asthma management
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No. Prohibited from regulations and contracts; Fear of inappropriate use of data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nghia Quang Bui, MD, PhD study chair
Can Tho University of Medicine and Pharmacy
Ly Cong Tran, MD, MSc study director
Can Tho University of Medicine and Pharmacy
Thang Hoang Le, MD principal investigator
Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine-Based Education in people with Uncontrolled Asthma and Telemedicine-Based Education, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thang Hoang Le, MD (+84962024776, hoangthang0899@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of asthma control (time frame: At second follow-up visit (ranging from 4 to 24 weeks after enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.