AsthmaNCT03335046
Home Visits to Optimize Medical and Educational Success Among Sacramento Schoolchildren With Asthma
A study testing Home Visit in people with Asthma and Chronic School Absenteeism, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Asthma, Chronic School Absenteeism
- What is being tested?
- Home Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Underlying chronic conditions such as cystic fibrosis, chronic lung disease with oxygen dependence, immunodeficiency syndromes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95817
About this study
Official title: 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.
- Conditions
- Asthma, Chronic School Absenteeism
- Being tested
- Home Visit, Standard Care
- Keywords
- Home Visit, School Absenteeism
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home VisitBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Home Visit; Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Missed School Days
The number of school days missed over the course of an academic year
Measured: One academic year
Secondary outcomes (3)
Healthcare Utilization
Number of emergency department or urgent care visits for asthma
Measured: One academic year
Asthma Symptom Report
Patient and family self-report of number of days where asthma symptoms were experienced, collected monthly
Measured: One academic year
Asthma Control Test
Numeric score from the Childhood Asthma Control Test, collected monthly
Measured: One academic year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start29 Nov 2017
- Primary completion1 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335046
- Sponsor's protocol ID
- 1114637
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2017
- Last updated
- 12 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project HOMES: Home Visits to Optimize Medical and Educational Success
- ClinicalTrials.gov ID
- NCT03335046
- Acronym / sponsor ID
- 1114637
- Conditions
- Asthma, Chronic School Absenteeism
- Keywords
- Home Visit, School Absenteeism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Home VisitThe 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. |
| Wait-List Control | Other | Behavioral: Home Visit, Behavioral: Standard CareThe 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Underlying chronic conditions such as cystic fibrosis, chronic lung disease with oxygen dependence, immunodeficiency syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home VisitThe 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. | Behavioural | Intervention, Wait-List Control |
| Standard CareStandard 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. | Behavioural | Wait-List Control |
Primary outcome
Missed School Days
Time frame: One academic year
The number of school days missed over the course of an academic year
3 secondary outcomes
Healthcare Utilization
Time frame: One academic year
Asthma Symptom Report
Time frame: One academic year
Asthma Control Test
Time frame: One academic year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Visit in people with Asthma and Chronic School Absenteeism, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Missed School Days (time frame: One academic year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.