A Study to Develop and Implement the Asthma-Guidance and Prediction System to Improve Management of Asthma Symptoms in Children
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004435
NCT ID: NCT02865967
Sponsor Protocol Number: 15-004435
About this study
Asthma is the most common chronic condition in children and one of the five most burdensome diseases in the United States. However, research and care for childhood asthma is limited by an inefficient use of electronic medical records to assist with large-scale studies and care. The purpose of this study is to test the use and effectiveness of the asthma-Guidance and Prediction System (a-GPS) within the Asthma Management Program, a current care coordination program for the asthma care of children aged 5-17 years at Mayo Clinic.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- For children in block 1
- Must be enrolled in AMP at the time of study enrollment
- For Children in Block 2
- Physician diagnosis of persistent asthma by NLP program from the list of physician diagnoses referring to persistent asthma
- Has a persistent asthma equivalent condition defined by
- The Healthcare Effectiveness Data and Information Set (e.g., ER visit or hospitalization for asthma during the past 12 months)
- The National Asthma Education and Prevention Program (e.g., ≥ 2 exacerbations requiring oral systemic corticosteroids in the past 6 months for children aged 0-4 years and 12 months for those aged ≥ 5 years)
- Has a physician diagnosis of asthma with controller medication (e.g., inhaled corticosteroid) documented in the past 12 months, but was not enrolled in AMP at the time of enrollment or during run-in period
- For children in block 3
- Must meet the criteria for asthma delineated in Table 1 in protocol for asthma and recurrent asthma-like symptoms, but do not have a documentation of a diagnosis of asthma in medical records aged 0-17 years
Exclusion Criteria
- For all blocks
- Non-Olmsted County residents
- Is not enrolled in Mayo Clinic downtown pediatric practice
- Has no research authorization for using medical records for research
- Is on immunosuppressive therapy
- Has any condition making asthma ascertainment difficult for Block 3
- Pulmonary function tests that showed forced expiratory volume at one second (FEV1) to be consistently below 50% predicted or diminished diffusion capacity
- Tracheobronchial foreign body at or about the incidence date of asthma
- Wheezing occurring only in response to anesthesia or medications
- Bullous emphysema or pulmonary fibrosis on chest radiograph
- Homozygous alpha 1-protease inhibitor deficiency alpha1-antitrypsin
- Cystic fibrosis
- Other major chest disease such as severe kyphoscoliosis or bronchiectasis
- Declines to participate in the study
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Young Juhn, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available