Asthma in Children
Conditions
Keywords
Asthma, Telemedicine
Brief 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. 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.
Interventions
BEHAVIORALStandard of Care Education
Education regarding recognition and removal of in-home asthma triggers
OTHERInteractive Video (IAV) Telemedicine
Interactive video assessment of asthma triggers in the home.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 5 years and ≤ 18 years 2. Have a diagnosis of persistent asthma as defined by national guidelines criteria1 3. Patient receives care in Arkansas Children's Hospital (ACH) primary care, in patient and/or specialty clinics 4. 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 5. English speaking participants/parents 6. Access to WIFI, smartphone or mobile device (tablet)
Exclusion criteria
1. Age \<5 or \>18 years 2. Non-English speaking participants/parents 3. Patients not receiving primary and/or asthma specialty care or inpatient services at ACH 4. Inability of patient or family to participate in TM evaluation due to lack of access to WIFI or smartphone or mobile device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in ACT Score Between Telemedicine and Standard of Care Groups | 6 months | 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. |
| Patient Satisfaction | 6 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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 | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Standard of Care Education | Total | Telemedicine Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 27 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.76 years STANDARD_DEVIATION 3.59 | 10.14 years STANDARD_DEVIATION 3.7 | 11.52 years STANDARD_DEVIATION 3.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 21 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 2 Participants |
| Region of Enrollment United States | 14 participants | 27 participants | 13 participants |
| Sex: Female, Male Female | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
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
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telemedicine Arm | Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation | 0 Participants |
| Standard of Care Education | Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation | 0 Participants |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Telemedicine Arm | Differences in ACT Score Between Telemedicine and Standard of Care Groups | Enrollment ACT score | 23.3 score on a scale | Standard Deviation 2.36 |
| Telemedicine Arm | Differences in ACT Score Between Telemedicine and Standard of Care Groups | 6 Month ACT score | 23.3 score on a scale | Standard Deviation 2.36 |
| Standard of Care Education | Differences in ACT Score Between Telemedicine and Standard of Care Groups | Enrollment ACT score | 21.25 score on a scale | Standard Deviation 2.165 |
| Standard of Care Education | Differences in ACT Score Between Telemedicine and Standard of Care Groups | 6 Month ACT score | 22 score on a scale | Standard Deviation 3 |
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
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telemedicine Arm | Patient Satisfaction | Very satisfied | 2 Participants |
| Telemedicine Arm | Patient Satisfaction | Not at all satisfied | 0 Participants |
| Telemedicine Arm | Patient Satisfaction | Somewhat satisfied | 0 Participants |
| Telemedicine Arm | Patient Satisfaction | Missing data | 2 Participants |
| Telemedicine Arm | Patient Satisfaction | Completely satisfied | 4 Participants |
| Standard of Care Education | Patient Satisfaction | Missing data | 4 Participants |
| Standard of Care Education | Patient Satisfaction | Completely satisfied | 4 Participants |
| Standard of Care Education | Patient Satisfaction | Very satisfied | 1 Participants |
| Standard of Care Education | Patient Satisfaction | Somewhat satisfied | 0 Participants |
| Standard of Care Education | Patient Satisfaction | Not at all satisfied | 0 Participants |