- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03335046
Home Visits to Optimize Medical and Educational Success Among Sacramento Schoolchildren With Asthma
November 10, 2020 updated by: University of California, Davis
Project HOMES: Home Visits to Optimize Medical and Educational Success
This study will establish a multi-disciplinary home visitation team consisting of a medical provider and school teacher or staff member, and will evaluate whether a series of visits from this team will help decrease school absenteeism among children with asthma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Sacramento, California, United States, 95817
- University of California Davis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students in elementary school (K-6) in the Sacramento City Unified School District
- Identified as at risk for chronic absenteeism based on previous year and/or first 8 weeks of school year
- Have a current diagnosis of asthma
Exclusion Criteria:
- Underlying chronic conditions such as cystic fibrosis, chronic lung disease with oxygen dependence, immunodeficiency syndromes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
The intervention arm will receive the home visit intervention, consisting of 2 visits to the home by a team consisting of a pediatric medical provider and a school teacher or school support staff member.
This team will evaluate the child's home environment to assess for potential asthma triggers that may lead to school absenteeism, and provide strategies and material goods to help reduce those triggers.
|
The intervention will consist of a series of home visitations to chronically absent students with co-morbid asthma.
These visits will consist of a home environment evaluation, medication adherence and knowledge assessment, distribution of home environmental allergen reduction items such as mattress and pillow encasements, as well as review and reinforcement of any asthma action plans or care plans provided by patient's primary care physicians or medical home.
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Other: Wait-List Control
The control group will receive standard interventions carried out by the school system for students at risk for chronic absenteeism.
Following the study observation period, this control group will then receive the home visits performed for the intervention group.
|
The intervention will consist of a series of home visitations to chronically absent students with co-morbid asthma.
These visits will consist of a home environment evaluation, medication adherence and knowledge assessment, distribution of home environmental allergen reduction items such as mattress and pillow encasements, as well as review and reinforcement of any asthma action plans or care plans provided by patient's primary care physicians or medical home.
Standard care will refer to the procedures carried out by the school district to address students with chronic absenteeism.
This includes parent-teacher and parent-school administrator meetings and communications and may also include home visits carried out by classroom teachers or student support center staff.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Missed School Days
Time Frame: One academic year
|
The number of school days missed over the course of an academic year
|
One academic year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare Utilization
Time Frame: One academic year
|
Number of emergency department or urgent care visits for asthma
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One academic year
|
|
Asthma Symptom Report
Time Frame: One academic year
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Patient and family self-report of number of days where asthma symptoms were experienced, collected monthly
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One academic year
|
|
Asthma Control Test
Time Frame: One academic year
|
Numeric score from the Childhood Asthma Control Test, collected monthly
|
One academic year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2017
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
July 30, 2019
Study Registration Dates
First Submitted
November 3, 2017
First Submitted That Met QC Criteria
November 3, 2017
First Posted (Actual)
November 7, 2017
Study Record Updates
Last Update Posted (Actual)
November 12, 2020
Last Update Submitted That Met QC Criteria
November 10, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1114637
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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