Asthma in Children Clinical Trial
Official title:
Evaluation of a Remote Asthma Monitoring Program to Improve Health Outcomes in Pediatric Asthma
Verified date | August 2023 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective of this pilot study to is to determine the overall impact of a clinical program of remote medication monitoring administered by St. Mary's Homecare on disease control in pediatric asthma patients. The central hypothesis is that a short-term program of remote asthma medication monitoring paired with home visits and asthma education will be associated with a sustained improvement in asthma symptom control in children over time.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | September 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 21 Years |
Eligibility | Inclusion Criteria: - Age 3- 21 years - Diagnosis of persistent asthma (mild, moderate, severe) previously diagnosed by a physician - Diagnosis of poorly controlled asthma or and asthma control test (ACT) score of <19 Exclusion Criteria: - Patients who have severe cognitive delay, significant mental illness which impairs daily functioning or are non-verbal will be excluded as they are less likely to benefit from the educational techniques administered - Primary language other than English or Spanish |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in asthma control test (ACT) scores | This outcome will compare ACT scores at the time of enrollment, to month 6 and month 12 scores | Baseline (enrollment), Month 6 and Month12 | |
Secondary | Change in percent of Controller Medication administered | The percent of prescribed medication doses administered per month with comparison of mean percentage at month 3, month 6 and month 12 | 3 months, 6 months and 12months | |
Secondary | Change in number of Rescue Medication doses administered | The number of rescue medication doses administered per month, with comparison of mean number of doses at month 3, month 6 and month 12 | 3 months, 6 months and 12months | |
Secondary | Change in health-care use: Number of physician visits | This secondary outcome will compare the number of physician visits due to asthma in the 12 month period pre-enrollment, to the number of physician visits due to asthma during the study period in month 12 (at completion of study). | Enrollment, Month 12 | |
Secondary | Change in health-care use: Number of Emergency Department (ED) visits | This secondary outcome will compare the number of ED visits due to asthma in the 12 month period pre-enrollment, to the number of ED visits due to asthma during the study period in month 12 (at completion of study). | Enrollment, Month 12 | |
Secondary | Change in health-care use: Number of Hospitalizations | This secondary outcome will compare the number of hospitalizations due to asthma in the 12 month period pre-enrollment, to the number of hospitalizations due to asthma during the study period in month 12 (at completion of study). | Enrollment, Month 12 | |
Secondary | Change in health-care use: Number of oral steroid courses | This secondary outcome will compare the number of oral steroid courses prescribed due to an asthma exacerbation in the 12 month period pre-enrollment, to the number of oral steroid courses prescribed over the study period at month 12. | Enrollment, Month 12 | |
Secondary | Change in number of missed school days | Number of missed school days due to asthma in the 12-month period prior to enrollment compared to number of school days missed over the study period at month 12. | Enrollment, month 12 |
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