An interventional study of Standard of Care Education and Interactive Video (IAV) Telemedicine in Asthma in Children, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by University of Arkansas · Not applicable, Interventional, and Prevention
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 27 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Interactive Video (IAV) Telemedicine
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.
Behavioral: Standard of Care Education
Education regarding recognition and removal of in-home asthma triggers
Interactive video assessment of asthma triggers in the home.
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
Time frame: 4 months
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.
Time frame: 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"
Time frame: 6 months
| Milestone | Telemedicine Arm | Standard of Care Education |
|---|---|---|
| Started | 13 | 14 |
| Completed | 3 | 4 |
| Not completed | 10 | 10 |
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
| Participants | Telemedicine Arm | Standard of Care Education |
|---|---|---|
| Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation | 0 | 0 |
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.
| score on a scale | Telemedicine Arm | Standard of Care Education |
|---|---|---|
| Enrollment ACT score | 23.3 ± 2.36 | 21.25 ± 2.165 |
| 6 Month ACT score | 23.3 ± 2.36 | 22 ± 3 |
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"
| Participants | Telemedicine Group | Standard of Care Education |
|---|---|---|
| Completely satisfied | 4 | 4 |
| Very satisfied | 2 | 1 |
| Somewhat satisfied | 0 | 0 |
| Not at all satisfied | 0 | 0 |
| Missing data | 2 | 4 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telemedicine Arm | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Standard of Care Education | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Telemedicine Arm | Standard of Care Education | Total |
|---|---|---|---|
| <=18 years | 13 | 14 | 27 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Telemedicine Arm | Standard of Care Education | Total |
|---|---|---|---|
| Mean | 11.52 ± 3.27 | 8.76 ± 3.59 | 10.14 ± 3.7 |
| Sex: Female, Male(Participants) | Telemedicine Arm | Standard of Care Education | Total |
|---|---|---|---|
| Female | 7 | 5 | 12 |
| Male | 6 | 9 | 15 |
| Race (NIH/OMB)(Participants) | Telemedicine Arm | Standard of Care Education | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 10 | 21 |
| White | 2 | 3 | 5 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Telemedicine Arm | Standard of Care Education | Total |
|---|---|---|---|
| United States | 13 | 14 | 27 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Arkansas