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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335046
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Asthma Chronic School Absenteeism Behavioral: Home Visit Behavioral: Standard Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Project HOMES: Home Visits to Optimize Medical and Educational Success
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.
Behavioral: Home Visit
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.

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.
Behavioral: Home Visit
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.

Behavioral: Standard Care
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 Measures :
  1. Missed School Days [ Time Frame: One academic year ]
    The number of school days missed over the course of an academic year


Secondary Outcome Measures :
  1. Healthcare Utilization [ Time Frame: One academic year ]
    Number of emergency department or urgent care visits for asthma

  2. Asthma Symptom Report [ Time Frame: One academic year ]
    Patient and family self-report of number of days where asthma symptoms were experienced, collected monthly

  3. Asthma Control Test [ Time Frame: One academic year ]
    Numeric score from the Childhood Asthma Control Test, collected monthly



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335046


Locations
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United States, California
University of California Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03335046    
Other Study ID Numbers: 1114637
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
Home Visit
School Absenteeism
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases