Adults 5 to 13, any sex, with Childhood Asthma or Community Health Workers. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Asthma ControlPrimary· Baseline and 12 months
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
Baseline
Group
Value
95% CI
P+S+
1.35
1.16 – 1.54
S+ Alone
1.42
1.23 – 1.62
P+ Alone
1.38
1.23 – 1.53
Control
1.37
1.22 – 1.51
12 Months
Group
Value
95% CI
P+S+
0.74
0.56 – 0.92
S+ Alone
0.85
0.67 – 1.03
P+ Alone
0.85
0.72 – 0.99
Control
0.97
0.84 – 1.03
Difference (Month 12 minus Baseline)
Group
Value
95% CI
P+S+
-0.61
-0.82 – -0.40
S+ Alone
-0.57
-0.78 – -0.36
P+ Alone
-0.53
-0.69 – -0.37
Control
-0.39
-0.55 – -0.23
Change in Daytime Asthma SymptomsSecondary· Baseline and 12 months
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 sc
Baseline
Group
Value
95% CI
P+S+
1
0 – 3
S+ Alone
1.5
0 – 3
P+ Alone
1
0 – 4
Control
1
0 – 3
12 Months
Group
Value
95% CI
P+S+
0
0 – 1
S+ Alone
1
0 – 2
P+ Alone
0
0 – 2
Control
1
0 – 2
Change in Nighttime SymptomsSecondary· Baseline and 12 months
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 d
Baseline
Group
Value
95% CI
P+S+
0
0 – 2
S+ Alone
0
0 – 2
P+ Alone
0
0 – 2
Control
0
0 – 2
12 Months
Group
Value
95% CI
P+S+
0
0 – 1
S+ Alone
0
0 – 1
P+ Alone
0
0 – 1
Control
0
0 – 2
Change in School AbsencesSecondary· Baseline and 12 months
School report of child's school absences pre and post study enrollment
Baseline
Group
Value
95% CI
P+S+
11
3 – 20
S+ Alone
10
4 – 23
P+ Alone
17
7 – 24
Control
13
7 – 20
12 Months
Group
Value
95% CI
P+S+
12
6 – 26
S+ Alone
13
7 – 28
P+ Alone
16
7 – 24
Control
12
7 – 23
Change in Emergency Department (ED) VisitsSecondary· Baseline and 12 months
Comparison of the change in asthma-related Emergency Department visits from baseline to 12 months for each intervention group
baseline
Group
Value
95% CI
P+S+
1
0 – 1
S+ Alone
1
0 – 2
P+ Alone
1
1 – 2
Control
1
0 – 2
12 months
Group
Value
95% CI
P+S+
0
0 – 1
S+ Alone
0
0 – 1
P+ Alone
0
0 – 1
Control
0
0 – 1
Change in HospitalizationsSecondary· Baseline and 12 months
Comparison of the change in asthma-related hospitalizations from baseline to 12 months for each intervention group
baseline
Group
Value
95% CI
P+S+
0
0 – 1
S+ Alone
0
0 – 1
P+ Alone
0
0 – 1
Control
0
0 – 1
12 months
Group
Value
95% CI
P+S+
0
0 – 0
S+ Alone
0
0 – 0
P+ Alone
0
0 – 0
Control
0
0 – 0
Change in Asthma Emotional Functioning DomainSecondary· Baseline and 12 months
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.
Baseline
Group
Value
95% CI
P+S+
5.72
± 1.26
S+ Alone
5.79
± 1.18
P+ Alone
5.55
± 1.32
Control
5.63
± 1.25
12 Months
Group
Value
95% CI
P+S+
6.47
± 0.78
S+ Alone
6.21
± 1.00
P+ Alone
6.15
± 1.08
Control
6.16
± 1.10
Change in Activity Limitations DomainSecondary· Baseline and 12 months
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.
Baseline
Group
Value
95% CI
P+S+
5.13
± 1.51
S+ Alone
5.18
± 1.53
P+ Alone
5.00
± 1.67
Control
5.09
± 1.69
12 Months
Group
Value
95% CI
P+S+
6.09
± 1.13
S+ Alone
5.89
± 1.25
P+ Alone
5.79
± 1.47
Control
5.91
± 1.43
Baseline School Organizational Climate IndexSecondary· At start of school intervention
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
Group
Value
95% CI
SOCI Collegial Leadership
538.83
± 110.95
SOCI Professional Teacher Behavior
528.8
± 144.88
SOCI Achievement Press
471.46
± 121.64
SOCI Institutional Vulnerability
441.59
± 86.28
Baseline School LeadershipSecondary· At start of school intervention
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.
Group
Value
95% CI
ILS Total
1.76
± 1.16
ILS Proactive Leadership
1.82
± 1.24
ILS Knowledgeable Leadership
1.57
± 1.2
ILS Supportive Leadership
1.7
± 1.2
ILS Perseverant Leadership
2.03
± 1.27
Baseline School Staff AttitudesSecondary· At start of school intervention
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.
Group
Value
95% CI
EBPAS Total
2.53
± 0.65
EBPAS Requirements
2.31
± 1.2
EBPAS Appeal
2.42
± 0.91
EBPAS Openness
2.56
± 0.87
EBPAS Divergence
1.01
± 0.86
Sponsor's own description
This project uses community health workers (CHW) or lay health educators to implement asthma interventions that have been proven to work in the primary care setting and in schools. The objective is to integrate the home, school, healthcare system, and community for 600 school-aged asthmatic children in West Philadelphia through use of CHWs.
The children enrolled in the study will be randomized to one of four groups including: primary care CHW, school CHW, primary care and school CHW or the control group (no CHW).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Philadelphia
Last refreshed: 30 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03514485.