Asthma in ChildrenNCT04896502
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
A study testing Interactive Video (IAV) Telemedicine in people with Asthma in Children, run by University of Arkansas at 1 site in United States.
Trial summary
The study is about comparing asthma home assessments/interventions by telemedicine compared to providing education alone. Interactive Video (IAV) defines telemedicine. It allows two-way communication in real-time with both audio and visual communication between the subject and someone from the study team. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Interactive Video (IAV) Telemedicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥ 5 years and ≤ 18 years
- Have a diagnosis of persistent asthma as defined by national guidelines criteria1
- Patient receives care in Arkansas Children's Hospital (ACH) primary care, in patient and/or specialty clinics
- Patient has had at least one or more acute exacerbations of asthma within the 12 months prior to enrollment that led to an emergency department visit, hospital admission, or prescription for systemic steroids
- English speaking participants/parents
- Access to WIFI, smartphone or mobile device (tablet)
Who cannot join
- Age <5 or >18 years
- Non-English speaking participants/parents
- Patients not receiving primary and/or asthma specialty care or inpatient services at ACH
- Inability of patient or family to participate in TM evaluation due to lack of access to WIFI or smartphone or mobile device
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
The study is about comparing asthma home assessments/interventions by telemedicine compared to providing education alone. Interactive Video (IAV) defines telemedicine. It allows two-way communication in real-time with both audio and visual communication between the subject and someone from the study team. It is similar to using Face Time on a mobile device. Asthma home assessments/interventions are used to identify things in a home that can make asthma symptoms worse, called triggers. Reducing these triggers in the home can improve asthma.
Read the detailed description
In this study, supplies will be given to some participants to help reduce or remove triggers from the home. One example is dust mites. These are microscopic bugs that are found in every home, cannot be seen by the naked eye, and make asthma symptoms worse. Part of the study includes collecting two dust samples from home to check dust mite levels at the beginning of the study and at the end. This study may help elucidate whether telemedicine home assessments work better than education alone at lowering dust mite levels and improving a child's asthma symptoms.
- Conditions
- Asthma in Children
- Being tested
- Standard of Care Education, Interactive Video (IAV) Telemedicine
- Keywords
- Asthma, Telemedicine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care EducationBehavioural
Education regarding recognition and removal of in-home asthma triggers
Interactive Video (IAV) TelemedicineOther
Interactive video assessment of asthma triggers in the home.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Arm | Experimental | For the proposed study, participants will randomized to receive TM home assessments/interventions performed by a trained home visitor (HV) or standard of care asthma trigger education by the HV. Those who are randomized to TM home assessments/interventions will complete a baseline home assessment and two follow-up visits, 2 months apart. Visits will assess the presence of potential asthma triggers in the home and frequency of asthma symptoms/exacerbations. TM participants will be provided education and materials necessary to reduce asthma triggers in the home. Follow-up visits will assess the interval change in presence of asthma triggers, change in daily asthma symptoms/exacerbations, and participant/family retention of education. Receives: Other: Interactive Video (IAV) Telemedicine |
| Standard of Care Education | Active comparator | For subjects randomized to receive standard of care asthma education, written and verbal information will be provided regarding identification and removal of potential asthma triggers in the home but no formal assessment of the home will be performed, nor will participants in this arm receive trigger reduction materials. Receives: Behavioral: Standard of Care Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation
Comparison of D. pteronyssinus levels collected in participant homes at baseline and at end of study with measure of number of subjects with a significant change
Measured: 4 months
Secondary outcomes (2)
Differences in ACT Score Between Telemedicine and Standard of Care Groups
We will measure differences in ACT scores from baseline to 6 months between the Telemedicine and Standard of Care groups. Asthma Control Test (ACT) is a 5 question (<12 years of age) or 7 question (>/= 12 years of age) test utilized to assess asthma control. Scores range from 0 to 25. The maximum score is 25 and a score of 19 or less indicates "not well-controlled" asthma.
Measured: 6 months
Patient Satisfaction
Patient satisfaction measured by standardized survey. Respondents were asked "How satisfied were you with your overall experience?" and were scored on a scale from "Complete Satisfied" to "Not at All Satisfied"
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start26 Sep 2019
- Primary completion8 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Pesek, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896502
- Sponsor's protocol ID
- 239759
- Status last verified
- Mar 2023
- First submitted
- 11 May 2021
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
- ClinicalTrials.gov ID
- NCT04896502
- Acronym / sponsor ID
- 239759
- Conditions
- Asthma in Children
- Keywords
- Asthma, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is about comparing asthma home assessments/interventions by telemedicine compared to providing education alone. Interactive Video (IAV) defines telemedicine. It allows two-way communication in real-time with both audio and visual communication between the subject and someone from the study team. It is similar to using Face Time on a mobile device. Asthma home assessments/interventions are used to identify things in a home that can make asthma symptoms worse, called triggers. Reducing these triggers in the home can improve asthma.
Detailed description
In this study, supplies will be given to some participants to help reduce or remove triggers from the home. One example is dust mites. These are microscopic bugs that are found in every home, cannot be seen by the naked eye, and make asthma symptoms worse. Part of the study includes collecting two dust samples from home to check dust mite levels at the beginning of the study and at the end. This study may help elucidate whether telemedicine home assessments work better than education alone at lowering dust mite levels and improving a child's asthma symptoms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Arm | Experimental | Other: Interactive Video (IAV) TelemedicineFor the proposed study, participants will randomized to receive TM home assessments/interventions performed by a trained home visitor (HV) or standard of care asthma trigger education by the HV. Those who are randomized to TM home assessments/interventions will complete a baseline home assessment and two follow-up visits, 2 months apart. Visits will assess the presence of potential asthma triggers in the home and frequency of asthma symptoms/exacerbations. TM participants will be provided education and materials necessary to reduce asthma triggers in the home. Follow-up visits will assess the interval change in presence of asthma triggers, change in daily asthma symptoms/exacerbations, and participant/family retention of education. |
| Standard of Care Education | Active comparator | Behavioral: Standard of Care EducationFor subjects randomized to receive standard of care asthma education, written and verbal information will be provided regarding identification and removal of potential asthma triggers in the home but no formal assessment of the home will be performed, nor will participants in this arm receive trigger reduction materials. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age ≥ 5 years and ≤ 18 years
- Have a diagnosis of persistent asthma as defined by national guidelines criteria1
- Patient receives care in Arkansas Children's Hospital (ACH) primary care, in patient and/or specialty clinics
- Patient has had at least one or more acute exacerbations of asthma within the 12 months prior to enrollment that led to an emergency department visit, hospital admission, or prescription for systemic steroids
- English speaking participants/parents
Key exclusion criteria (4 listed)
- Age <5 or >18 years
- Non-English speaking participants/parents
- Patients not receiving primary and/or asthma specialty care or inpatient services at ACH
- Inability of patient or family to participate in TM evaluation due to lack of access to WIFI or smartphone or mobile device
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 |
|---|---|---|
| Standard of Care EducationEducation regarding recognition and removal of in-home asthma triggers | Behavioural | Standard of Care Education |
| Interactive Video (IAV) TelemedicineInteractive video assessment of asthma triggers in the home. | Other | Telemedicine Arm |
Primary outcome
Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation
Time frame: 4 months
Comparison of D. pteronyssinus levels collected in participant homes at baseline and at end of study with measure of number of subjects with a significant change
2 secondary outcomes
Differences in ACT Score Between Telemedicine and Standard of Care Groups
Time frame: 6 months
Patient Satisfaction
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Robert Pesek, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Video (IAV) Telemedicine in people with Asthma in Children, run by University of Arkansas at 1 site in United States.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 17 Oct 2024. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation (time frame: 4 months). 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 17 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.