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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care Education | Behavioral | Education regarding recognition and removal of in-home asthma triggers |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Pesek, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemedicine Arm | 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. Interactive Video (IAV) Telemedicine: Interactive video assessment of asthma triggers in the home. |
| FG001 | Standard of Care Education | 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. Standard of Care Education: Education regarding recognition and removal of in-home asthma triggers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telemedicine Arm | 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. Interactive Video (IAV) Telemedicine: Interactive video assessment of asthma triggers in the home. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 4 months |
|
6 months
No patients experienced an adverse event, serious adverse event, or mortality during the study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telemedicine Arm | 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. Interactive Video (IAV) Telemedicine: Interactive video assessment of asthma triggers in the home. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robbie Pesek, MD | Arkansas Children's Hospital | 501-364-3149 | rdpesek@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2021 | Mar 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Interactive Video (IAV) Telemedicine | Other | Interactive video assessment of asthma triggers in the home. |
|
| 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" | 6 months |
| BG001 | Standard of Care Education | 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. Standard of Care Education: Education regarding recognition and removal of in-home asthma triggers |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care Education | 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. Standard of Care Education: Education regarding recognition and removal of in-home asthma triggers |
|
|
| Secondary | 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. | Posted | Median | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | 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" | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Standard of Care Education | 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. Standard of Care Education: Education regarding recognition and removal of in-home asthma triggers | 0 | 4 | 0 | 4 | 0 | 4 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Somewhat satisfied |
|
| Not at all satisfied |
|
| Missing data |
|