Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02141893
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2014-05-12
Brief Title:
Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
Sponsor:
University of Puerto Rico
Organization:
University of Puerto Rico
Study Overview
Official Title:
Effectiveness of a Multi-level Clinic and Family Asthma Intervention With a Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this group-randomized trial was to test the effectiveness of a new comprehensive program which the investigators called CALMA -plus in increasing controller medication use and reducing asthma symptoms CALMA-plus involved the CALMA home-based family intervention plus educational training of physicians and nurses as well as screening for asthma in clinics serving Medicaid island Puerto Rican children with asthma Because the provider training was expected to have an impact on the entire clinical setting where trained providers work as well as the patients using that setting the investigators randomized clinic groups rather than individual patients The investigators compared the CALMA-Plus intervention to a CALMA-only group which the investigators expected to obtain the same benefits as the investigators have previously documented
Detailed Description:
Puerto Rico has high rates of pediatric asthma and morbidity associated in part with poor family asthma management and low rates of controller medication use A previous study found a family management intervention called CALMA to be effective in reducing asthma symptoms and service utilization However CALMA was not effective in increasing the use of controller medications CALMA- plus was developed to address this issue by adding to CALMA components of educational training of physicians and nurses and screening for asthma in clinics serving Medicaid Puerto Rican children with persistent asthma A total of 404 children in eight clinics were studied after forming four pairs of clinics and randomizing the clinics 11 to CALMA-only or CALMA-plus within each pair After adjusting for clinic variation the study failed to demonstrate that the CALMA-plus intervention was more efficacious than the CALMA- only intervention for increasing reported controller medication use or decreasing symptoms in children with persistent asthma Both groups had lower rates of asthma symptoms and service utilization consistent with previous results of the CALMA-only intervention Limitations of the study were small number of clinics available comparison of the experimental intervention with an evidence based intervention and limited exposure to some aspects of the intervention More effective interventions may include aggressive case management and providing the physician with more relevant information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P60MD00226 | OTHER_GRANT | National Center on Minority Health and Health Disparities | None |