Trial Outcomes & Findings for West Philadelphia Controls Asthma (NCT NCT03514485)
NCT ID: NCT03514485
Last Updated: 2024-10-30
Results Overview
Asthma Control Questionnaire (ACQ) developed by E.F. Juniper et al. is a 6-item recall of asthma control indicators over the past week. The 6-item recall includes awakening at night with asthma symptoms, asthma symptoms upon waking, activity limitations due to asthma symptoms, shortness of breath, wheezing, and administration of asthma rescue medications. The score range for the ACQ is 0 to 6, with lower numbers indicating greater asthma control and higher numbers indicating worse asthma control. Based on existing literature, the minimal clinically important difference (MCID) is 0.5. The range for this cohort is 0.2-2.3) For all analyses, we combined the P+S- group with the P+S0 group to describe the P+ only group. Similarly, we combined the P-S- group with the P-S0 group to create the control group.
COMPLETED
NA
626 participants
Baseline and 12 months
2024-10-30
Participant Flow
Participant milestones
| Measure |
P+S+ (Partner School)
This arm includes children who attend one of the partnering schools and are randomized to receive the enhanced school intervention Open Airways for Schools Plus, School-Based Asthma Therapy and the primary care intervention Yes We Can Children's Asthma Program.
|
P-S+ (Partner School)
This arm includes children who attend one of the partnering schools and are randomized to receive the school intervention Open Airways for Schools Plus.
Open Airways for School Plus: Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes:
1. Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school community health workers (CHW) once each semester.
2. Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment.
3. Asthma education for school staff/personnel at the start of each school year.
4. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia.
|
P+S- (Partner School)
This arm includes children who attend one of the partnering schools and are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.
Yes We Can Children's Asthma Program: The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.
|
P-S- (Partner School)
This arm includes children who attend one of the partnering schools and are randomized to the control group (no primary care or school intervention).
|
P+S0 (Non-Partner School)
This arm includes children who do not attend one of the partnering schools and are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.
|
P-S0 (Non-Partner School)
This arm includes children who do not attend one of the partnering schools and are randomized to the control group (no primary care intervention and ineligible for the school intervention).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
121
|
112
|
110
|
112
|
82
|
89
|
|
Overall Study
COMPLETED
|
116
|
108
|
105
|
111
|
79
|
84
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
5
|
1
|
3
|
5
|
Reasons for withdrawal
| Measure |
P+S+ (Partner School)
This arm includes children who attend one of the partnering schools and are randomized to receive the enhanced school intervention Open Airways for Schools Plus, School-Based Asthma Therapy and the primary care intervention Yes We Can Children's Asthma Program.
|
P-S+ (Partner School)
This arm includes children who attend one of the partnering schools and are randomized to receive the school intervention Open Airways for Schools Plus.
Open Airways for School Plus: Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes:
1. Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school community health workers (CHW) once each semester.
2. Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment.
3. Asthma education for school staff/personnel at the start of each school year.
4. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia.
|
P+S- (Partner School)
This arm includes children who attend one of the partnering schools and are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.
Yes We Can Children's Asthma Program: The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.
|
P-S- (Partner School)
This arm includes children who attend one of the partnering schools and are randomized to the control group (no primary care or school intervention).
|
P+S0 (Non-Partner School)
This arm includes children who do not attend one of the partnering schools and are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.
|
P-S0 (Non-Partner School)
This arm includes children who do not attend one of the partnering schools and are randomized to the control group (no primary care intervention and ineligible for the school intervention).
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
2
|
0
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
1
|
2
|
1
|
Baseline Characteristics
West Philadelphia Controls Asthma
Baseline characteristics by cohort
| Measure |
P+S+ (Partner School)
n=121 Participants
This arm includes children who attend one of the partnering schools and are randomized to receive the enhanced school intervention Open Airways for Schools Plus, School-Based Asthma Therapy and the primary care intervention Yes We Can Children's Asthma Program.
|
P-S+ (Partner School)
n=112 Participants
This arm includes children who attend one of the partnering schools and are randomized to receive the school intervention Open Airways for Schools Plus.
Open Airways for School Plus: Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes:
1. Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester.
2. Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment.
3. Asthma education for school staff/personnel at the start of each school year.
4. School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia.
|
P+S- (Partner School)
n=110 Participants
This arm includes children who attend one of the partnering schools and are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.
Yes We Can Children's Asthma Program: The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.
|
P-S- (Partner School)
n=112 Participants
This arm includes children who attend one of the partnering schools and are randomized to the control group (no primary care or school intervention).
|
P+S0 (Non-Partner School)
n=82 Participants
This arm includes children who do not attend one of the partnering schools and are randomized to receive the primary care intervention Yes We Can Children's Asthma Program.
|
P-S0 (Non-Partner School)
n=89 Participants
This arm includes children who do not attend one of the partnering schools and are randomized to the control group (no primary care intervention and ineligible for the school intervention).
|
Total
n=626 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age
|
9.3 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
8.8 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
8.7 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
8.4 years
STANDARD_DEVIATION 2.4 • n=4 Participants
|
8.4 years
STANDARD_DEVIATION 2.4 • n=21 Participants
|
8.5 years
STANDARD_DEVIATION 2.4 • n=10 Participants
|
8.7 years
STANDARD_DEVIATION 2.4 • n=115 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
263 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
363 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
119 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
88 Participants
n=10 Participants
|
601 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
BMI
< 5th Percentile
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
BMI
5th to 84th Percentile
|
55 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
292 Participants
n=115 Participants
|
|
BMI
85th to 94th Percentile
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
87 Participants
n=115 Participants
|
|
BMI
At or Above 95th Percentile
|
49 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
219 Participants
n=115 Participants
|
|
BMI
Missing
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Asthma Control Score
|
1.3 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
1.5 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 1.2 • n=4 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 1.2 • n=21 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.3 • n=10 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 1.3 • n=115 Participants
|
|
Asthma Control Score Groups
0 to <1.25
|
68 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
328 Participants
n=115 Participants
|
|
Asthma Control Score Groups
>=1.25
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
294 Participants
n=115 Participants
|
|
Asthma Control Score Groups
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Hospitalized Overnight for Asthma
Ever
|
78 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
61 Participants
n=10 Participants
|
408 Participants
n=115 Participants
|
|
Hospitalized Overnight for Asthma
Past 12 Months
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
214 Participants
n=115 Participants
|
|
In the ICU for Asthma
Ever
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
75 Participants
n=115 Participants
|
|
In the ICU for Asthma
Past 12 Months
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Emergency Department Visit for Asthma
Ever
|
109 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
78 Participants
n=10 Participants
|
537 Participants
n=115 Participants
|
|
Emergency Department Visit for Asthma
Past 12 Months
|
66 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
328 Participants
n=115 Participants
|
|
On a Prednisone "Burst" for Asthma
Ever
|
121 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
89 Participants
n=10 Participants
|
626 Participants
n=115 Participants
|
|
On a Prednisone "Burst" for Asthma
Past 12 Months
|
120 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
89 Participants
n=10 Participants
|
625 Participants
n=115 Participants
|
|
Quality of Life Score (Overall)
|
5.5 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.3 • n=4 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 1.1 • n=21 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 1.4 • n=10 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 1.3 • n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Asthma Control Questionnaire (ACQ) developed by E.F. Juniper et al. is a 6-item recall of asthma control indicators over the past week. The 6-item recall includes awakening at night with asthma symptoms, asthma symptoms upon waking, activity limitations due to asthma symptoms, shortness of breath, wheezing, and administration of asthma rescue medications. The score range for the ACQ is 0 to 6, with lower numbers indicating greater asthma control and higher numbers indicating worse asthma control. Based on existing literature, the minimal clinically important difference (MCID) is 0.5. The range for this cohort is 0.2-2.3) For all analyses, we combined the P+S- group with the P+S0 group to describe the P+ only group. Similarly, we combined the P-S- group with the P-S0 group to create the control group.
Outcome measures
| Measure |
P+S+
n=120 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=112 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=189 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=201 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Change in Asthma Control
Baseline
|
1.35 units on a scale
Interval 1.16 to 1.54
|
1.42 units on a scale
Interval 1.23 to 1.62
|
1.38 units on a scale
Interval 1.23 to 1.53
|
1.37 units on a scale
Interval 1.22 to 1.51
|
—
|
|
Change in Asthma Control
12 Months
|
0.74 units on a scale
Interval 0.56 to 0.92
|
0.85 units on a scale
Interval 0.67 to 1.03
|
0.85 units on a scale
Interval 0.72 to 0.99
|
0.97 units on a scale
Interval 0.84 to 1.03
|
—
|
|
Change in Asthma Control
Difference (Month 12 minus Baseline)
|
-0.61 units on a scale
Interval -0.82 to -0.4
|
-0.57 units on a scale
Interval -0.78 to -0.36
|
-0.53 units on a scale
Interval -0.69 to -0.37
|
-0.39 units on a scale
Interval -0.55 to -0.23
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Comparison of the change in daytime symptoms from baseline to 12 months for each intervention group. This data was collected at 3 month intervals with a 2 week recall for number of days with symptoms. This question asks how many days the child has had daytime asthma symptoms in the last 2 weeks and the number of days with asthma symptoms is the answer value (0-14 days). P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Outcome measures
| Measure |
P+S+
n=118 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=106 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=182 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=194 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Change in Daytime Asthma Symptoms
Baseline
|
1 number of symptom days
Interval 0.0 to 3.0
|
1.5 number of symptom days
Interval 0.0 to 3.0
|
1 number of symptom days
Interval 0.0 to 4.0
|
1 number of symptom days
Interval 0.0 to 3.0
|
—
|
|
Change in Daytime Asthma Symptoms
12 Months
|
0 number of symptom days
Interval 0.0 to 1.0
|
1 number of symptom days
Interval 0.0 to 2.0
|
0 number of symptom days
Interval 0.0 to 2.0
|
1 number of symptom days
Interval 0.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Comparison of the change in nighttime symptoms from baseline to 12 months for each intervention group. This question asks how many days the child has had nighttime asthma symptoms in the last 2 weeks and the number of days with asthma symptoms is the answer value (0-14 days). P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Outcome measures
| Measure |
P+S+
n=118 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=107 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=182 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=194 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Change in Nighttime Symptoms
Baseline
|
0 number of symptom days
Interval 0.0 to 2.0
|
0 number of symptom days
Interval 0.0 to 2.0
|
0 number of symptom days
Interval 0.0 to 2.0
|
0 number of symptom days
Interval 0.0 to 2.0
|
—
|
|
Change in Nighttime Symptoms
12 Months
|
0 number of symptom days
Interval 0.0 to 1.0
|
0 number of symptom days
Interval 0.0 to 1.0
|
0 number of symptom days
Interval 0.0 to 1.0
|
0 number of symptom days
Interval 0.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
School report of child's school absences pre and post study enrollment
Outcome measures
| Measure |
P+S+
n=75 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=75 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=61 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=67 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Change in School Absences
Baseline
|
11 days
Interval 3.0 to 20.0
|
10 days
Interval 4.0 to 23.0
|
17 days
Interval 7.0 to 24.0
|
13 days
Interval 7.0 to 20.0
|
—
|
|
Change in School Absences
12 Months
|
12 days
Interval 6.0 to 26.0
|
13 days
Interval 7.0 to 28.0
|
16 days
Interval 7.0 to 24.0
|
12 days
Interval 7.0 to 23.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Comparison of the change in asthma-related Emergency Department visits from baseline to 12 months for each intervention group
Outcome measures
| Measure |
P+S+
n=121 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=112 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=192 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=201 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Change in Emergency Department (ED) Visits
baseline
|
1 number of ED visits
Interval 0.0 to 1.0
|
1 number of ED visits
Interval 0.0 to 2.0
|
1 number of ED visits
Interval 1.0 to 2.0
|
1 number of ED visits
Interval 0.0 to 2.0
|
—
|
|
Change in Emergency Department (ED) Visits
12 months
|
0 number of ED visits
Interval 0.0 to 1.0
|
0 number of ED visits
Interval 0.0 to 1.0
|
0 number of ED visits
Interval 0.0 to 1.0
|
0 number of ED visits
Interval 0.0 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Comparison of the change in asthma-related hospitalizations from baseline to 12 months for each intervention group
Outcome measures
| Measure |
P+S+
n=121 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=112 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=192 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=201 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Change in Hospitalizations
12 months
|
0 number of hospitalizations
Interval 0.0 to 0.0
|
0 number of hospitalizations
Interval 0.0 to 0.0
|
0 number of hospitalizations
Interval 0.0 to 0.0
|
0 number of hospitalizations
Interval 0.0 to 0.0
|
—
|
|
Change in Hospitalizations
baseline
|
0 number of hospitalizations
Interval 0.0 to 1.0
|
0 number of hospitalizations
Interval 0.0 to 1.0
|
0 number of hospitalizations
Interval 0.0 to 1.0
|
0 number of hospitalizations
Interval 0.0 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Comparison of the change in caregivers' self-reported quality of life from baseline to 12 months for each intervention group. Data was collected using Juniper's Pediatric Asthma Caregiver's Quality of Life Questionnaire designed for children aged 7 to 17 years of age. The PAQLQ has 23 questions in 3 domains, including emotional function. The questions ask about a 1 week recall. The range for answer choices is 1-7, with the higher number indicating a better quality of life. The score for the subscale is the mean of the answers for that subscale.
Outcome measures
| Measure |
P+S+
n=120 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=112 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=188 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=199 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Change in Asthma Emotional Functioning Domain
Baseline
|
5.72 units on a scale
Standard Deviation 1.26
|
5.79 units on a scale
Standard Deviation 1.18
|
5.55 units on a scale
Standard Deviation 1.32
|
5.63 units on a scale
Standard Deviation 1.25
|
—
|
|
Change in Asthma Emotional Functioning Domain
12 Months
|
6.47 units on a scale
Standard Deviation 0.78
|
6.21 units on a scale
Standard Deviation 1.00
|
6.15 units on a scale
Standard Deviation 1.08
|
6.16 units on a scale
Standard Deviation 1.10
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: P+ Alone group includes children randomized to receive only the primary care intervention. This group combines two arms P+S- and P+S0 (participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0). Similarly, the control group combines P-S- and P-S0 (participants in both groups did not receive any intervention, just usual care).
Comparison of the change in caregivers' self-reported quality of life from baseline to 12 months for each intervention group. he Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) by Juniper et al. is a 13-item measure of asthma caregiver's quality of life in two domains, including activity limitation. The score for the subscale is the mean of the answers for the subscale. All items are weighted equally and the score range is 1 - 7, with lower numbers indicating poor quality of life and higher numbers indicating better quality of life around caring for a child with asthma.
Outcome measures
| Measure |
P+S+
n=120 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=112 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=188 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=199 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Change in Activity Limitations Domain
12 Months
|
6.09 units on a scale
Standard Deviation 1.13
|
5.89 units on a scale
Standard Deviation 1.25
|
5.79 units on a scale
Standard Deviation 1.47
|
5.91 units on a scale
Standard Deviation 1.43
|
—
|
|
Change in Activity Limitations Domain
Baseline
|
5.13 units on a scale
Standard Deviation 1.51
|
5.18 units on a scale
Standard Deviation 1.53
|
5.00 units on a scale
Standard Deviation 1.67
|
5.09 units on a scale
Standard Deviation 1.69
|
—
|
SECONDARY outcome
Timeframe: At start of school interventionPopulation: School teachers and staff are the respondents to the surveys, not the children who are the participants of this study.
The Standardized Organizational Climate Index (SOCI) is a 30-item descriptive measure for schools. The index has four dimensions: principal leadership, teacher professionalism, achievement press for students to perform academically, and vulnerability to the community. The score range for each questionnaire item is 1 - 4. The answers assign the value of 1 to "rarely occurs," 2 to "sometimes occurs," 3 to "often occurs," and 4 to "very frequently occurs. For the subscores, ninety-nine percent of the scores range from 200 to 800 with a population mean of 500 and a population standard deviation of 100. Higher scores indicate a better school climate. Scores are converted to standardized scores and compared with national norms.
Outcome measures
| Measure |
P+S+
n=253 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=253 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=253 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=253 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Baseline School Organizational Climate Index
|
538.83 units on a scale
Standard Deviation 110.95
|
528.8 units on a scale
Standard Deviation 144.88
|
471.46 units on a scale
Standard Deviation 121.64
|
441.59 units on a scale
Standard Deviation 86.28
|
—
|
SECONDARY outcome
Timeframe: At start of school interventionPopulation: School teachers and staff are the respondents to the surveys, not the children who are the participants of this study.
The Implementation Leadership Scale (ILS) is comprised of 12 items assessing the degree to which a leader is Proactive, Knowledgeable, Supportive, and shows Perseverance in implementing evidence-based practice. The range for total score and each subscale score is 0 - 4. Higher scores represent better implementation leadership. The mean of the subscale scores yields the total score.
Outcome measures
| Measure |
P+S+
n=253 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=253 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=253 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=253 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
n=253 Participants
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Baseline School Leadership
|
1.76 units on a scale
Standard Deviation 1.16
|
1.82 units on a scale
Standard Deviation 1.24
|
1.57 units on a scale
Standard Deviation 1.2
|
1.7 units on a scale
Standard Deviation 1.2
|
2.03 units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: At start of school interventionPopulation: School teachers and staff are the respondents to the surveys, not the children who are the participants of this study.
The Evidence-Based Practice Attitude Scale (EBPAS) is a 15-item self-report measure of attitudes toward adoption of EBPs. It consists of four subscales: Appeal (is EBP intuitively appealing), Requirements (would an EBP be used if required), Openness (general openness to innovation), and Divergence (perceived divergence between EBP and current practice). Total score range is 0 - 60. The Appeal, Openness, and Divergence subscales have a range of 0 - 16. The Requirements subscale has a range of 0 - 12. Higher scores indicate more positive attitudes. Subscales are summed to compute a total score.
Outcome measures
| Measure |
P+S+
n=253 Participants
This group includes children who attend one of the partnering schools and were randomized to receive both the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy) and the primary care intervention (Yes We Can Children's Asthma Program).
|
S+ Alone
n=253 Participants
This group includes children randomized to receive only the enhanced school intervention (Open Airways for Schools Plus, School-Based Asthma Therapy).
|
P+ Alone
n=253 Participants
This group includes children randomized to receive only the primary care intervention (Yes We Can Children's Asthma Program) and combines participants who attended a partner school (P+S-) and those who did not attend a partner school (P+S0).
|
Control
n=253 Participants
This group includes children who were randomized to the control group (no primary care or school intervention) and combines participants who attended a partner school (P-S-) and those who did not attend a partner school (P-S0).
|
ILS Perseverant Leadership
n=253 Participants
Subscale of ILS that refers to the degree to which the leader is consistent, unwavering, and responsive to EBP implementation issues.
|
|---|---|---|---|---|---|
|
Baseline School Staff Attitudes
|
2.53 units on a scale
Standard Deviation 0.65
|
2.31 units on a scale
Standard Deviation 1.2
|
2.42 units on a scale
Standard Deviation 0.91
|
2.56 units on a scale
Standard Deviation 0.87
|
1.01 units on a scale
Standard Deviation 0.86
|
Adverse Events
P+S+ (Partner School)
P-S+ (Partner School)
P+S- (Partner School)
P-S- (Partner School)
P+S0 (Non-Partner School)
P-S0 (Non-Partner School)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tyra Bryant-Stephens, MD
Children's Hospital of Philadelphia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60