Trial Outcomes & Findings for Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers (NCT NCT04896502)
NCT ID: NCT04896502
Last Updated: 2024-10-17
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
4 months
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
Baseline characteristics by cohort
| Measure |
Telemedicine Arm
n=13 Participants
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.
|
Standard of Care Education
n=14 Participants
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
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
11.52 years
STANDARD_DEVIATION 3.27 • n=5 Participants
|
8.76 years
STANDARD_DEVIATION 3.59 • n=7 Participants
|
10.14 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsComparison 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
Outcome measures
| Measure |
Telemedicine Arm
n=3 Participants
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.
|
Standard of Care Education
n=4 Participants
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
|
|---|---|---|
|
Number of Subjects With a Significant Change in D. Pteronyssinus Levels at End of Study Evaluation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsWe 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.
Outcome measures
| Measure |
Telemedicine Arm
n=3 Participants
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.
|
Standard of Care Education
n=4 Participants
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
|
|---|---|---|
|
Differences in ACT Score Between Telemedicine and Standard of Care Groups
Enrollment ACT score
|
23.3 score on a scale
Standard Deviation 2.36
|
21.25 score on a scale
Standard Deviation 2.165
|
|
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
|
22 score on a scale
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 6 monthsPatient 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"
Outcome measures
| Measure |
Telemedicine Arm
n=8 Participants
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.
|
Standard of Care Education
n=9 Participants
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
|
|---|---|---|
|
Patient Satisfaction
Completely satisfied
|
4 Participants
|
4 Participants
|
|
Patient Satisfaction
Very satisfied
|
2 Participants
|
1 Participants
|
|
Patient Satisfaction
Somewhat satisfied
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction
Not at all satisfied
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction
Missing data
|
2 Participants
|
4 Participants
|
Adverse Events
Telemedicine Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place