Trial Outcomes & Findings for Reducing Asthma Morbidity In High Risk Minority Preschool Children (NCT NCT01519453)
NCT ID: NCT01519453
Last Updated: 2021-05-11
Results Overview
The Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
404 participants
Primary outcome timeframe
Baseline, 3, 6, 9 and 12 months
Results posted on
2021-05-11
Participant Flow
2 refused to complete a baseline assessment after consent 1 participant dropped due to no asthma after consent 3 families were pilot participants and their data is not represented in final outcomes except in sponsor reporting
Participant milestones
| Measure |
Home Based Asthma Education Arm
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver.
|
Control Arm
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
Caregiver is not provided a control arm specific intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
199
|
|
Overall Study
3 Month
|
160
|
181
|
|
Overall Study
6 Month
|
153
|
175
|
|
Overall Study
9 Month
|
159
|
166
|
|
Overall Study
COMPLETED
|
147
|
163
|
|
Overall Study
NOT COMPLETED
|
52
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Asthma Morbidity In High Risk Minority Preschool Children
Baseline characteristics by cohort
| Measure |
Home Based Asthma Education
n=199 Participants
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver.
|
Control
n=199 Participants
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
Caregiver is not provided a control arm specific intervention.
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Child in caregiver-child pair · <=18 years
|
199 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
|
Age, Categorical
Child in caregiver-child pair · Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Child in caregiver-child pair · >=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Caregiver in caregiver-child pair · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Caregiver in caregiver-child pair · Between 18 and 65 years
|
199 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
|
Age, Categorical
Caregiver in caregiver-child pair · >=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
Child in caregiver-child pair
|
4.2 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
4.2 years
STANDARD_DEVIATION 0.8 • n=7 Participants
|
4.2 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Age, Continuous
Caregiver in caregiver-child pair
|
30.9 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Child in caregiver-child pair · Female
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Child in caregiver-child pair · Male
|
123 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Sex: Female, Male
Caregiver in caregiver-child pair · Female
|
184 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Sex: Female, Male
Caregiver in caregiver-child pair · Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Child in caregiver-child pair · Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Child in caregiver-child pair · Not Hispanic or Latino
|
193 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
384 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Child in caregiver-child pair · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child in caregiver-child pair · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child in caregiver-child pair · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child in caregiver-child pair · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child in caregiver-child pair · Black or African American
|
189 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child in caregiver-child pair · White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child in caregiver-child pair · More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Child in caregiver-child pair · Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
199 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, 9 and 12 monthsPopulation: Participants analyzed represent children with asthma enrolled in the protocol as caregiver-child pairs. Number analyzed per row vary since some families were unable to be contacted for specific assessment time points, but were able to be contacted for future assessments.
The Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control.
Outcome measures
| Measure |
Home Based Asthma Education
n=199 Participants
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver.
|
Control
n=199 Participants
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
Caregiver is not provided a control arm specific intervention.
|
|---|---|---|
|
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
Baseline
|
70 score on a scale
Interval 50.0 to 80.0
|
75 score on a scale
Interval 55.0 to 85.0
|
|
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
3 months
|
85 score on a scale
Interval 70.0 to 95.0
|
80 score on a scale
Interval 60.0 to 90.0
|
|
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
6 months
|
85 score on a scale
Interval 75.0 to 95.0
|
85 score on a scale
Interval 70.0 to 95.0
|
|
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
9 months
|
85 score on a scale
Interval 65.0 to 95.0
|
85 score on a scale
Interval 75.0 to 95.0
|
|
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
12 months
|
85 score on a scale
Interval 70.0 to 95.0
|
85 score on a scale
Interval 75.0 to 95.0
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 9 and 12 monthsPopulation: Participants analyzed represent children with asthma enrolled in the protocol as caregiver-child pairs. Number analyzed per row vary since some families were unable to be contacted for specific assessment time points, but were able to be contacted for future assessments.
Aggregate number of ED visits for asthma in past 90 days for all participants.
Outcome measures
| Measure |
Home Based Asthma Education
n=199 Participants
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver.
|
Control
n=199 Participants
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
Caregiver is not provided a control arm specific intervention.
|
|---|---|---|
|
Total Number of Emergency Department (ED) Visits [Child]
Baseline
|
65 ED visits
|
50 ED visits
|
|
Total Number of Emergency Department (ED) Visits [Child]
3 months
|
34 ED visits
|
42 ED visits
|
|
Total Number of Emergency Department (ED) Visits [Child]
6 months
|
28 ED visits
|
32 ED visits
|
|
Total Number of Emergency Department (ED) Visits [Child]
9 months
|
37 ED visits
|
38 ED visits
|
|
Total Number of Emergency Department (ED) Visits [Child]
12 months
|
31 ED visits
|
35 ED visits
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Participants analyzed represent children with asthma enrolled in the protocol as caregiver-child pairs. Number analyzed per row vary since some families were unable to be contacted for specific assessment time points, but were able to be contacted for future assessments.
Aggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants.
Outcome measures
| Measure |
Home Based Asthma Education
n=199 Participants
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver.
|
Control
n=199 Participants
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
Caregiver is not provided a control arm specific intervention.
|
|---|---|---|
|
Total Number of Hospitalizations [Child]
Baseline
|
6 asthma related hospitalizations
|
10 asthma related hospitalizations
|
|
Total Number of Hospitalizations [Child]
12 months
|
7 asthma related hospitalizations
|
24 asthma related hospitalizations
|
Adverse Events
Home Based Asthma Education
Serious events: 8 serious events
Other events: 2 other events
Deaths: 0 deaths
Control
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home Based Asthma Education
n=398 participants at risk
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver.
|
Control
n=398 participants at risk
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
Caregiver is not provided a control arm specific intervention.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to asthma [child]
|
3.0%
6/199 • Number of events 9 • 12 months.
Reportable Adverse Events included: Deaths of child or consented caregiver, Asthma related hospitalization for child or consented caregiver, formal complaint about study, any psychosocial adverse event related to the study intervention, or any other potential adverse event as identified by Principal Investigator. Note: 199 child/consented caregiver pairs were enrolled making a total of 398 per arm assessed for adverse events.
|
7.0%
14/199 • Number of events 24 • 12 months.
Reportable Adverse Events included: Deaths of child or consented caregiver, Asthma related hospitalization for child or consented caregiver, formal complaint about study, any psychosocial adverse event related to the study intervention, or any other potential adverse event as identified by Principal Investigator. Note: 199 child/consented caregiver pairs were enrolled making a total of 398 per arm assessed for adverse events.
|
|
Blood and lymphatic system disorders
Non asthma related hospitalization [child]
|
0.00%
0/199 • 12 months.
Reportable Adverse Events included: Deaths of child or consented caregiver, Asthma related hospitalization for child or consented caregiver, formal complaint about study, any psychosocial adverse event related to the study intervention, or any other potential adverse event as identified by Principal Investigator. Note: 199 child/consented caregiver pairs were enrolled making a total of 398 per arm assessed for adverse events.
|
0.50%
1/199 • Number of events 1 • 12 months.
Reportable Adverse Events included: Deaths of child or consented caregiver, Asthma related hospitalization for child or consented caregiver, formal complaint about study, any psychosocial adverse event related to the study intervention, or any other potential adverse event as identified by Principal Investigator. Note: 199 child/consented caregiver pairs were enrolled making a total of 398 per arm assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to asthma [consented caregiver]
|
1.0%
2/199 • Number of events 2 • 12 months.
Reportable Adverse Events included: Deaths of child or consented caregiver, Asthma related hospitalization for child or consented caregiver, formal complaint about study, any psychosocial adverse event related to the study intervention, or any other potential adverse event as identified by Principal Investigator. Note: 199 child/consented caregiver pairs were enrolled making a total of 398 per arm assessed for adverse events.
|
1.0%
2/199 • Number of events 2 • 12 months.
Reportable Adverse Events included: Deaths of child or consented caregiver, Asthma related hospitalization for child or consented caregiver, formal complaint about study, any psychosocial adverse event related to the study intervention, or any other potential adverse event as identified by Principal Investigator. Note: 199 child/consented caregiver pairs were enrolled making a total of 398 per arm assessed for adverse events.
|
Other adverse events
| Measure |
Home Based Asthma Education
n=398 participants at risk
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver.
|
Control
n=398 participants at risk
This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
Caregiver is not provided a control arm specific intervention.
|
|---|---|---|
|
Social circumstances
Psychosocial Event [consented caregiver]
|
1.0%
2/199 • Number of events 2 • 12 months.
Reportable Adverse Events included: Deaths of child or consented caregiver, Asthma related hospitalization for child or consented caregiver, formal complaint about study, any psychosocial adverse event related to the study intervention, or any other potential adverse event as identified by Principal Investigator. Note: 199 child/consented caregiver pairs were enrolled making a total of 398 per arm assessed for adverse events.
|
0.00%
0/199 • 12 months.
Reportable Adverse Events included: Deaths of child or consented caregiver, Asthma related hospitalization for child or consented caregiver, formal complaint about study, any psychosocial adverse event related to the study intervention, or any other potential adverse event as identified by Principal Investigator. Note: 199 child/consented caregiver pairs were enrolled making a total of 398 per arm assessed for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place