AsthmaNCT01451944
Effect of Home Health Case Management on Asthma Morbidity
A study testing education in people with Asthma and Childhood Asthma, run by University of Louisville at 1 site in United States.
Trial summary
The objective of our program is to evaluate the effect of home health nurse intervention and education on hospital admissions, ER utilization and asthma control of Passport asthma patients. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Asthma, Childhood Asthma
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2014
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 3-17 years with asthma who attend our clinic who present with an asthma exacerbation to the clinic, ER or hospital.
Who cannot join
- Patients with airway anomalies or tracheostomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children and Youth Project
Louisville, Kentucky, 40202
About this study
Official title: Effect of Home Health Nurse Case Management on Asthma Morbidity
The objective of our program is to evaluate the effect of home health nurse intervention and education on hospital admissions, ER utilization and asthma control of Passport asthma patients. The investigators hypothesize that case management and in home education by nurses will decrease hospitalizations and ER asthma visits and improves disease control in our population.
Our clinic population consists of primarily inner-city, low income, medicaid recipients. This population suffers from severe asthma much more than the typical pediatric population. Asthma remains the most frequent cause of hospital admission for our patient population. Home health nurse asthma education and home visits have been reported to reduce asthma triggers in the home and improve asthma control. The unique partnership between the pediatrician and the home health nurse will give us a better understanding of the health needs for this population, will improve quality of care and deliver more cost effective care.
Read the detailed description
Asthma patients age 3-17 enrolled in our clinic who have been seen in the ER, hospital or clinic for an asthma exacerbation will be invited to participate. Once enrolled they will have a home health nurse visit their home and provide medical assessment, asthma education and determine if the patients has all needed medications available. They enrolled patient will receive another home visit at 1, 4, and 12 months after enrollment. The medical record will be reviewed and ER visits and hospitalizations recorded.
- Conditions
- Asthma, Childhood Asthma
- Being tested
- education
- Keywords
- Asthma, Home Health Nursing, Patient education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
home asthma case management and education
| Study group | Role | What they receive |
|---|---|---|
| asthma education and case management | Experimental | asthma education and case management Receives: Behavioral: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased asthma hospitalization rates
patients will be followed for 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: no one enrolled
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 LouisvilleThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith A Theriot, University of Louisville
- Investigators
- Judith A Theriot, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451944
- Sponsor's protocol ID
- 11.0320
- Status last verified
- Dec 2014
- First submitted
- 4 Oct 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home Health Nurse Case Management on Asthma Morbidity
- ClinicalTrials.gov ID
- NCT01451944
- Acronym / sponsor ID
- 11.0320
- Conditions
- Asthma, Childhood Asthma
- Keywords
- Asthma, Home Health Nursing, Patient education
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no one enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Oct 2011 (estimated)
- 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.
The objective of our program is to evaluate the effect of home health nurse intervention and education on hospital admissions, ER utilization and asthma control of Passport asthma patients. The investigators hypothesize that case management and in home education by nurses will decrease hospitalizations and ER asthma visits and improves disease control in our population.
Our clinic population consists of primarily inner-city, low income, medicaid recipients. This population suffers from severe asthma much more than the typical pediatric population. Asthma remains the most frequent cause of hospital admission for our patient population. Home health nurse asthma education and home visits have been reported to reduce asthma triggers in the home and improve asthma control. The unique partnership between the pediatrician and the home health nurse will give us a better understanding of the health needs for this population, will improve quality of care and deliver more cost effective care.
Detailed description
Asthma patients age 3-17 enrolled in our clinic who have been seen in the ER, hospital or clinic for an asthma exacerbation will be invited to participate. Once enrolled they will have a home health nurse visit their home and provide medical assessment, asthma education and determine if the patients has all needed medications available. They enrolled patient will receive another home visit at 1, 4, and 12 months after enrollment. The medical record will be reviewed and ER visits and hospitalizations recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asthma education and case management | Experimental | Behavioral: educationasthma education and case management |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children age 3-17 years with asthma who attend our clinic who present with an asthma exacerbation to the clinic, ER or hospital.
Key exclusion criteria (1 listed)
- Patients with airway anomalies or tracheostomy
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 |
|---|---|---|
| educationhome asthma case management and education | Behavioural | asthma education and case management |
Primary outcome
Decreased asthma hospitalization rates
Time frame: 1 year
patients will be followed for 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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.
Judith A Theriot, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Asthma and Childhood Asthma, run by University of Louisville 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 1 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: withdrawn, as of the sponsor's last update on 2 Dec 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
Decreased asthma hospitalization rates (time frame: 1 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 2 Dec 2014.