Home Centered Comprehensive Care (HCCC) for Children With Asthma
HCCC
Home-Centered Comprehensive Care (HCCC) for Children With Severe Asthma: A Pilot Trial
3 other identifiers
interventional
63
1 country
1
Brief Summary
The purpose of this study is to assess whether comprehensive care enhanced with new technology to optimize asthma care in the home (using both a special sensor to track inhaler use and a hand-held PIKO-1 device to assess patients' forced expiratory volume in the 1st second \[FEV1\]) is effective in reducing total days when medical treatment is given outside the home (in clinic, emergency department, or hospital) among children with severe asthma receiving comprehensive care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Oct 2014
Typical duration for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 4, 2017
May 1, 2017
2.2 years
September 30, 2014
May 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medical treatment outside of home
Total number of days when medical treatment was given outside the home (in a clinic, ED, or hospital). Measured by parent report every 3 months for both groups.
2 years
Secondary Outcomes (5)
Days of missed school
2 years
Pulmonary Function Tests. (PFTs)
2 years
Parental Satisfaction
2 years
Total costs of clinic and hospital care
2 years
Physician Services Cost to Reimbursement
2 years
Study Arms (2)
Standard comprehensive care
ACTIVE COMPARATORStandard comprehensive care at High Risk Children's Clinic
Enhanced comprehensive care
EXPERIMENTALstandard comprehensive care at the High Risk Children's Clinic enhaced with new technologies: * If between 2 and 5 years old--\> will receive Home-centered comprehensive care with the propeller * 5 and above--\> will receive home-centered comprehensive care with propeller and PIKO
Interventions
Standard comprehensive care at High Risk Children's Clinic
standard comprehensive care at the High Risk Children's Clinic enhaced with new technologies: * If between 2 and 5 years old--\> will receive Home-centered comprehensive care with the propeller * 5 and above--\> will receive home-centered comprehensive care with propeller and PIKO
Eligibility Criteria
You may not qualify if:
- other major lung disease (e.g. cystic fibrosis or bronchopulmonary dysplasia) or neuromuscular impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
High Risk Children's Clinic
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo A Mosquera, MD
University of Texas Medical School in Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 3, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2016
Study Completion
April 1, 2017
Last Updated
May 4, 2017
Record last verified: 2017-05