NCT03335046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

November 3, 2017

Last Update Submit

November 10, 2020

Conditions

Keywords

Home VisitSchool Absenteeism

Outcome Measures

Primary Outcomes (1)

  • Missed School Days

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

    One academic year

Secondary Outcomes (3)

  • Healthcare Utilization

    One academic year

  • Asthma Symptom Report

    One academic year

  • Asthma Control Test

    One academic year

Study Arms (2)

Intervention

EXPERIMENTAL

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

Wait-List Control

OTHER

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 VisitBehavioral: Standard Care

Interventions

Home VisitBEHAVIORAL

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.

InterventionWait-List Control
Standard CareBEHAVIORAL

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.

Wait-List Control

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Underlying chronic conditions such as cystic fibrosis, chronic lung disease with oxygen dependence, immunodeficiency syndromes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

House CallsStandard of Care

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationQuality Indicators, Health CareQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

November 29, 2017

Primary Completion

July 1, 2019

Study Completion

July 30, 2019

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations