Personalized Asthma Care Team (PACT)

This study has been completed.
Sponsor:
Collaborators:
The Cleveland Foundation
University Hospitals of Cleveland
Case Western Reserve University
Information provided by (Responsible Party):
Susan Redline, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01423461
First received: August 24, 2011
Last updated: August 25, 2011
Last verified: August 2011
  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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Enrollment: 201
Study Start Date: July 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423461

Sponsors and Collaborators
Brigham and Women's Hospital
The Cleveland Foundation
University Hospitals of Cleveland
Case Western Reserve University
Investigators
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
Pathologic Processes
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014