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| Name | Class |
|---|---|
| Verizon Foundation | OTHER |
| Luther Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm asthma self-management | Experimental | Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensor cap system for inhalers | Device | All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Guilbert, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Asthma Self-management | Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers. App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence. Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2017 |
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| App for SmartPhone | Other | All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence. |
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| Motivational interviews | Behavioral | All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills |
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| Telehealth clinic visits | Other | All subjects will have asthma medical visits via telehealth technology to assess asthma control. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Asthma Self-management | Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers. App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence. Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Baseline CASI score | Composite Asthma Severity Index (CASI) score, minimum value 0 and maximum value 20. A lower score shows improvement. | Mean | Standard Deviation | score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 21 participants were analyzed for the CASI score all participants value. Participants were grouped in two categories. 11 participants with baseline CASI >=4 were analyzed independently for the CASI score >=4 at Baseline Value. 10 participants with baseline CASI <4 were also analyzed independently for the CASI score <4 at Baseline Value. | Posted | Mean | Standard Deviation | Change in score on a scale | Baseline to 6 months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Asthma Self-management | Interventions include: Sensor cap system for inhalers App for SmartPhone Motivational interviews Telehealth clinic visits Sensor cap system for inhalers: All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers. App for SmartPhone: All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence. Motivational interviews: All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills Telehealth clinic visits: All subjects will have asthma medical visits via telehealth technology to assess asthma control. | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa Guilbert, MD, MS | Cincinnati Children's Hospital Medical Center | (513) 636-6771 | Theresa.Guilbert@cchmc.org |
| Mar 10, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2018 | Mar 10, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Change in CASI score <4 at Baseline |
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