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Supervised Asthma Medication in Schools (SAMS)

The Cost Effectiveness of School-Based Supervised Asthma Therapy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01997463
Acronym
SAMS
Enrollment
442
Registered
2013-11-28
Start date
2014-08-31
Completion date
2016-06-30
Last updated
2022-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Asthma

Brief summary

The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.

Detailed description

This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.

Interventions

DRUGSupervised asthma therapy in schools

Therapy observed daily in school. Asthma education by American Lung Association

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* A child with asthma attending a Tucson Unified School District elementary school selected for the study.

Exclusion criteria

* No asthma. * Not attending a Tucson Unified School District elementary school selected for the study.

Design outcomes

Primary

MeasureTime frameDescription
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)1 yearAn ACQ score of \> 1.5 means asthma is not well controlled. An ACQ score of \<= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ

Countries

United States

Participant flow

Participants by arm

ArmCount
Regular Therapy
Regular Asthma Therapy
192
Supervised Therapy
Supervised asthma therapy in schools Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association
250
Total442

Baseline characteristics

CharacteristicRegular TherapySupervised TherapyTotal
Age, Categorical
<=18 years
192 Participants250 Participants442 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
128 Participants168 Participants296 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
48 Participants57 Participants105 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
16 Participants25 Participants41 Participants
Race (NIH/OMB)
American Indian or Alaska Native
12 Participants32 Participants44 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
17 Participants24 Participants41 Participants
Race (NIH/OMB)
More than one race
62 Participants66 Participants128 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
4 Participants1 Participants5 Participants
Race (NIH/OMB)
Unknown or Not Reported
19 Participants34 Participants53 Participants
Race (NIH/OMB)
White
78 Participants92 Participants170 Participants
Sex: Female, Male
Female
72 Participants88 Participants160 Participants
Sex: Female, Male
Male
120 Participants162 Participants282 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1920 / 250
serious
Total, serious adverse events
0 / 1920 / 250

Outcome results

Primary

The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)

An ACQ score of \> 1.5 means asthma is not well controlled. An ACQ score of \<= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ

Time frame: 1 year

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 1ACQ score >1.5 (not well controlled)54 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 1ACQ score <=1.5(well controlled)74 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 1missing ACQ score64 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 2ACQ score >1.5 (not well controlled)56 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 2ACQ score <=1.5(well controlled)75 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 2missing ACQ score61 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 3ACQ score >1.5 (not well controlled)55 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 3ACQ score <=1.5(well controlled)75 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 3missing ACQ score62 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 4ACQ score >1.5 (not well controlled)60 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 4ACQ score <=1.5(well controlled)77 Participants
Regular TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 4missing ACQ score55 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 4ACQ score <=1.5(well controlled)123 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 1ACQ score >1.5 (not well controlled)70 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 3ACQ score >1.5 (not well controlled)65 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 1ACQ score <=1.5(well controlled)95 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 4ACQ score >1.5 (not well controlled)65 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 1missing ACQ score85 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 3ACQ score <=1.5(well controlled)116 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 2ACQ score >1.5 (not well controlled)73 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 4missing ACQ score62 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 2ACQ score <=1.5(well controlled)99 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 3missing ACQ score69 Participants
Supervised TherapyThe Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)Visit 2missing ACQ score78 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026