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Home Visits to Optimize Medical and Educational Success Among Sacramento Schoolchildren With Asthma

Primary Purpose

Asthma, Chronic School Absenteeism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Visit
Standard Care
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Home Visit, School Absenteeism

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Wait-List Control

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Missed School Days
The number of school days missed over the course of an academic year

Secondary Outcome Measures

Healthcare Utilization
Number of emergency department or urgent care visits for asthma
Asthma Symptom Report
Patient and family self-report of number of days where asthma symptoms were experienced, collected monthly
Asthma Control Test
Numeric score from the Childhood Asthma Control Test, collected monthly

Full Information

First Posted
November 3, 2017
Last Updated
November 10, 2020
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03335046
Brief Title
Home Visits to Optimize Medical and Educational Success Among Sacramento Schoolchildren With Asthma
Official Title
Project HOMES: Home Visits to Optimize Medical and Educational Success
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chronic School Absenteeism
Keywords
Home Visit, School Absenteeism

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a randomized wait-list control trial. Participants will be randomized to the intervention or control arm for the study observation period. At the conclusion of the observation period, the control group will receive the intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-List Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home Visit
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Missed School Days
Description
The number of school days missed over the course of an academic year
Time Frame
One academic year
Secondary Outcome Measure Information:
Title
Healthcare Utilization
Description
Number of emergency department or urgent care visits for asthma
Time Frame
One academic year
Title
Asthma Symptom Report
Description
Patient and family self-report of number of days where asthma symptoms were experienced, collected monthly
Time Frame
One academic year
Title
Asthma Control Test
Description
Numeric score from the Childhood Asthma Control Test, collected monthly
Time Frame
One academic year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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Home Visits to Optimize Medical and Educational Success Among Sacramento Schoolchildren With Asthma

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