Asthma
Conditions
Keywords
Telehealth, Sensor cap, School based care, Community health, AsthmaTreatSmart Application
Brief 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. 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.
Interventions
DEVICESensor cap system for inhalers
All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.
OTHERApp for SmartPhone
All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.
BEHAVIORALMotivational interviews
All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills
OTHERTelehealth clinic visits
All subjects will have asthma medical visits via telehealth technology to assess asthma control.
Sponsors
Verizon Foundation
Luther Foundation
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* active chronic disease apart from asthma or allergic disease * plans to change schools during the school year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Asthma Severity Index (CASI) Score | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Single Arm Asthma Self-management |
|---|---|
| Age, Categorical <=18 years | 21 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 13.67 years STANDARD_DEVIATION 2.46 |
| Baseline CASI score | 4.67 score on a scale STANDARD_DEVIATION 3.07 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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.
Time frame: Baseline to 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Arm Asthma Self-management | Change in Composite Asthma Severity Index (CASI) Score | Change in CASI score all participants | 0.14 Change in score on a scale | Standard Deviation 2.9 |
| Single Arm Asthma Self-management | Change in Composite Asthma Severity Index (CASI) Score | Change in CASI score >=4 at Baseline | 2.4 Change in score on a scale | Standard Deviation 2.5 |
| Single Arm Asthma Self-management | Change in Composite Asthma Severity Index (CASI) Score | Change in CASI score <4 at Baseline | -1.91 Change in score on a scale | Standard Deviation 1.22 |