Personalized Asthma Care Team (PACT)
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Purpose
"Individualized health care" refers to the development of strategies for disease management and health promotion that are informed by specific data on genetics and physiological processes that uniquely determine each person's health profile and potential responsiveness to interventions or susceptibility to environmental exposures.
Asthma, an inflammatory disorder of the airway, appears to be determined by multiple interacting genetic and environmental factors. Such risk factors include allergic responses, small airways, excess body weight, specific properties of airway smooth muscle, airway and generalized metabolic and inflammatory homeostasis, and exposures to environmental irritants, allergens, and psychosocial stressors. To date, asthma treatment strategies have been guided by "severity" guidelines rather than by characteristics of the child's specific phenotype (a child's underlying allergic tendency, extent of airway inflammation and airway smooth muscle dysfunction, or underlying obesity and metabolic perturbations). The growing availability of new classes of asthma medications that more directly target specific pathophysiological derangements will require accessing data on each child's asthma risk profiles to optimize selection of medications and other interventions that most specifically address the underlying pathophysiology while minimizing adverse treatment side effects.
The investigators propose to develop a model program for collecting relevant clinical information and genetic data on a high risk group of asthmatic children, including data on common co-morbidities, specifically obesity and sleep disorders; use this information to develop a comprehensive model database for characterizing children according to their health profiles; and use this characterization to initiate targeted interventions, while continuing long term follow up of these children to determine differential responsiveness to medications.
| Condition |
|---|
|
Asthma Sleep Disordered Breathing Obesity |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Individualized Health Care for Children With Common Chronic Diseases |
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All children seen at the pediatric pulmonology department with a diagnosis of asthma or symptoms of persistent wheeze, unexplained by an etiology other than asthma, ages 4 to 18 years will be recruited.
Inclusion Criteria:
- ages 4 to 18 years
- diagnosis of asthma or symptoms of persistent wheeze, unexplained by an etiology other than asthma
Exclusion Criteria:
- other severe co-morbidity (cystic fibrosis, sickle cell disease, chronic lung disease of prematurity, interstitial lung disease, cerebral palsy)
- inability of family to provide informed consent
- plans of the family to move out of the greater Cleveland area in the subsequent 24 months
- or inability to participate in regular follow up visits
Contacts and Locations| Study Director: | Susan Redline, M.D., M.P.H. | Brigham and Women's Hospital |
| Principal Investigator: | Kristie Ross, M.D. | University Hospitals of Cleveland |
| Principal Investigator: | Meeghan Hart, M.D. | University Hospitals of Cleveland |
| Principal Investigator: | Carol Rosen, M.D. | University Hospitals of Cleveland |
More Information
No publications provided
| Responsible Party: | Susan Redline, Senior Physician, Division of Sleep Medicine, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01423461 History of Changes |
| Other Study ID Numbers: | L2005-0254, KL2RR024990, UL1RR024989, 1U54CA116867, M01RR000080 |
| Study First Received: | August 24, 2011 |
| Last Updated: | August 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Respiratory Aspiration Asthma Obesity Sleep Apnea Syndromes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Bronchial Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Overnutrition Nutrition Disorders Overweight Body Weight Apnea Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013