AsthmaAFS4NCT02735174
Improving Asthma Care by Partnering With School Nurses to Bring Asthma Care Into the Inner-City Schools
A study testing Sensor cap system for inhalers, App for SmartPhone and Motivational interviews in people with Asthma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This is a pilot study to improve the partnership between Cincinnati Children's Medical Center (CCHMC), Cincinnati Public Schools (CPS), and Cincinnati Health Department (CHD) to reduce childhood asthma in the inner city schools of Cincinnati and CCHMC. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Sensor cap system for inhalers, App for SmartPhone and Motivational interviews
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 29 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- history of provider diagnosed asthma
- history of uncontrolled asthma in the past 12 months as measured by two asthma control Test (ACT) scores less than 20; or more than or equal to 1 emergency room visit or hospitalization for asthma; or more than or equal to 2 prednisone bursts with current persistent asthma as defined by National Asthma Education and Prevention Program (NAEPP) guidelines
- attendance at participating school
Who cannot join
- active chronic disease apart from asthma or allergic disease
- plans to change schools during the school year
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Phase 4: Improving Asthma Outcomes By Facilitating Patient-Centered Care At School (Asthma-Free School)
This is a pilot study to improve the partnership between Cincinnati Children's Medical Center (CCHMC), Cincinnati Public Schools (CPS), and Cincinnati Health Department (CHD) to reduce childhood asthma in the inner city schools of Cincinnati and CCHMC. We are calling this project "asthma-free schools" and bringing it to neighborhoods where the incidence of asthma is especially high. We have designed this study to work with school-based asthma care programs. Children with high-risk asthma will be asked to participate. "High-risk" will be defined as poorly controlled asthma, frequent school absences, and/or need for daily controller asthma medications. We will use a commercially available inhaler cap sensor to help track medication use and symptoms through a smartphone. The study visits will be done mostly at the school using telehealth technology similar to Skype.
Read the detailed description
This study is part of a community health collaboration between Cincinnati Children's Hospital Medical Center (CCHMC), the local public health department and designated inner city schools. The purpose is to address school-based asthma care barriers and then to test the efficacy of this program in a pilot study to improve asthma outcomes in 30 urban core youth.
Greater Cincinnati's geography places it at the environmentally tricky confluence of low-lying smog-trapping hills, three heavily traveled interstate highways, and high rate of allergen exposure. This makes it an area ripe for asthma. The overall rate of pediatric asthma in Greater Cincinnati is more than twice the national average and, in some urban-core neighborhoods, as high as 10 times the national rate.
Poor asthma control across the nation and locally in Cincinnati is associated with an overrepresentation of children from minority groups, low-income families, and single parent households who deal with economic hardship and familial strain compared to those with well-controlled asthma. Data show that no more than 50% of patients keep appointments or fill prescriptions, leading to continued poor asthma control and risk for future exacerbation.
This is an interventional pilot study where about 30 high-risk asthmatic participants will be identified to participate and a number of interventions will be incorporated including asthma specific questionnaires, use of a commercially available inhaler cap with monitoring sensor, a mobile software management platform that tracks adherence of all asthma medications, mobile based telehealth medical visits to assess asthma control, and mobile based telehealth adherence problem-solving interventions.
This proposal is funded through a Luther Foundation and Verizon Foundation philanthropic gifts.
- Conditions
- Asthma
- Being tested
- Sensor cap system for inhalers, App for SmartPhone, Motivational interviews, Telehealth clinic visits
- Keywords
- Telehealth, Sensor cap, School based care, Community health, AsthmaTreatSmart Application
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor cap system for inhalersDevice
Also called Propeller
All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.
App for SmartPhoneOther
All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.
Motivational interviewsBehavioural
All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills
Telehealth clinic visitsOther
All subjects will have asthma medical visits via telehealth technology to assess asthma control.
| Study group | Role | What they receive |
|---|---|---|
| Single arm asthma self-management | Experimental | Interventions include:
Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits Receives: Device: Sensor cap system for inhalers; Other: App for SmartPhone; Behavioral: Motivational interviews; Other: Telehealth clinic visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Asthma Severity Index (CASI) Score
Change in composite asthma severity index score (Baseline CASI score-6 month CASI score). A positive score indicates a better outcome.
[The CASI score has a minimum value = 0, maximum value = 20]. The rows represent the change from baseline in scores in all subjects and subsets of participants who obtained "CASI >=4 at baseline and "CASI <4" at baseline.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJan 2016
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Verizon Foundation, Luther Foundation
- Responsible party
- Principal investigator, Theresa Guilbert, MD, Children's Hospital Medical Center, Cincinnati
- Investigators
- Theresa Guilbert, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735174
- Sponsor's protocol ID
- CIN001_AFS4
- Acronym
- AFS4
- Status last verified
- Sep 2020
- First submitted
- 17 Feb 2016
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4: Improving Asthma Outcomes By Facilitating Patient-Centered Care At School (Asthma-Free School)
- ClinicalTrials.gov ID
- NCT02735174
- Acronym / sponsor ID
- AFS4 / CIN001_AFS4
- Conditions
- Asthma
- Keywords
- Telehealth, Sensor cap, School based care, Community health, AsthmaTreatSmart Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Verizon Foundation, Luther Foundation
- Study start
- Jan 2016
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to improve the partnership between Cincinnati Children's Medical Center (CCHMC), Cincinnati Public Schools (CPS), and Cincinnati Health Department (CHD) to reduce childhood asthma in the inner city schools of Cincinnati and CCHMC. We are calling this project "asthma-free schools" and bringing it to neighborhoods where the incidence of asthma is especially high. We have designed this study to work with school-based asthma care programs. Children with high-risk asthma will be asked to participate. "High-risk" will be defined as poorly controlled asthma, frequent school absences, and/or need for daily controller asthma medications. We will use a commercially available inhaler cap sensor to help track medication use and symptoms through a smartphone. The study visits will be done mostly at the school using telehealth technology similar to Skype.
Detailed description
This study is part of a community health collaboration between Cincinnati Children's Hospital Medical Center (CCHMC), the local public health department and designated inner city schools. The purpose is to address school-based asthma care barriers and then to test the efficacy of this program in a pilot study to improve asthma outcomes in 30 urban core youth.
Greater Cincinnati's geography places it at the environmentally tricky confluence of low-lying smog-trapping hills, three heavily traveled interstate highways, and high rate of allergen exposure. This makes it an area ripe for asthma. The overall rate of pediatric asthma in Greater Cincinnati is more than twice the national average and, in some urban-core neighborhoods, as high as 10 times the national rate.
Poor asthma control across the nation and locally in Cincinnati is associated with an overrepresentation of children from minority groups, low-income families, and single parent households who deal with economic hardship and familial strain compared to those with well-controlled asthma. Data show that no more than 50% of patients keep appointments or fill prescriptions, leading to continued poor asthma control and risk for future exacerbation.
This is an interventional pilot study where about 30 high-risk asthmatic participants will be identified to participate and a number of interventions will be incorporated including asthma specific questionnaires, use of a commercially available inhaler cap with monitoring sensor, a mobile software management platform that tracks adherence of all asthma medications, mobile based telehealth medical visits to assess asthma control, and mobile based telehealth adherence problem-solving interventions.
This proposal is funded through a Luther Foundation and Verizon Foundation philanthropic gifts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm asthma self-management | Experimental | Device: Sensor cap system for inhalers, Other: App for SmartPhone, Behavioral: Motivational interviews, Other: Telehealth clinic visitsInterventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- history of provider diagnosed asthma
- history of uncontrolled asthma in the past 12 months as measured by two asthma control Test (ACT) scores less than 20; or more than or equal to 1 emergency room visit or hospitalization for asthma; or more than or equal to 2 prednisone bursts with current persistent asthma as defined by National Asthma Education and Prevention Program (NAEPP) guidelines
- attendance at participating school
Key exclusion criteria (2 listed)
- active chronic disease apart from asthma or allergic disease
- plans to change schools during the school year
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 |
|---|---|---|
| Sensor cap system for inhalersAlso: PropellerAll subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers. | Device | Single arm asthma self-management |
| App for SmartPhoneAll subjects will be given smart phone with mobile software management platform to motivate and record medication adherence. | Other | Single arm asthma self-management |
| Motivational interviewsAll subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills | Behavioural | Single arm asthma self-management |
| Telehealth clinic visitsAll subjects will have asthma medical visits via telehealth technology to assess asthma control. | Other | Single arm asthma self-management |
Primary outcome
Change in Composite Asthma Severity Index (CASI) Score
Time frame: Baseline to 6 months
Change in composite asthma severity index score (Baseline CASI score-6 month CASI score). A positive score indicates a better outcome. [The CASI score has a minimum value = 0, maximum value = 20]. The rows represent the change from baseline in scores in all subjects and subsets of participants who obtained "CASI >=4 at baseline and "CASI <4" at baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Theresa Guilbert, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor cap system for inhalers, App for SmartPhone and Motivational interviews in people with Asthma, run by Children's Hospital Medical Center, Cincinnati 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 2 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 19 Oct 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?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Composite Asthma Severity Index (CASI) Score (time frame: Baseline to 6 months). 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 19 Oct 2020.