Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149500
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2005-09-06
Brief Title:
Social Support and Education in Asthma Follow-up SSEA
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Social Support and Education in Asthma Follow-up SSEA
Status:
COMPLETED
Status Verified Date:
2018-05
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:
SSEA
Brief Summary:
We will evaluate the effect of an eighteen-month asthma coaching intervention for parentscaregivers of children with asthma to reduce asthma morbidity The primary objective is to determine if asthma coaching will significantly reduce asthma morbidity as measured by a reduction in the number of ED visits and hospitalizations for the children during the 18 months of active coaching and during the 18 months after the coaching stops
We will provide half of the subjects parentscaregivers with access to assistance from an asthma coach for 18 months including 2 contacts with an asthma nurse during the first 6 months The other half of the subjects will not have an asthma coach but their children will have their usual routine care with their primary care providers The nurse and coach will help the subjects learn more about caring for their childrens asthma and improving interactions with the primary care providers for their children
We will provide half of the subjects parentscaregivers with access to assistance from an asthma coach for 18 months including 2 contacts with an asthma nurse during the first 6 months The other half of the subjects will not have an asthma coach but their children will have their usual routine care with their primary care providers The nurse and coach will help the subjects learn more about caring for their childrens asthma and improving interactions with the primary care providers for their children
Detailed Description:
BACKGROUND
Our previous NHLBI-supported study HL 57232 showed that a combination treatment of Coaching through follow-up phone calls 2 and 5 days following an index ED visit plus monetary incentive was highly effective in increasing the percentage of low-income urban children who received recommended primary care within 2 weeks of the ED visit for asthma 44 in the intervention group vs 29 in usual care p 00004 However the intervention was not associated with significant differences in morbidity subsequent ED visits We conclude that the intervention was effective in promoting the initial link to primary care but was not effective in sustaining that link or management practices to minimize acuity of symptoms during exacerbation
DESIGN NARRATIVE
Primary outcome The proportion of children of subjects in each group who have at least one ED visit for acute asthma symptoms during the thirty-six month period following enrollment
Key secondary outcomes A The proportion of children of subjects in each group who are hospitalized during the thirty-six month period following enrollment
B The proportion of children of subjects in each group who have either acute asthma visits or asthma-planning visits with their primary care providers
C The costs of asthma-related care during the thirty-six month period D Variables which may mediate or moderate the intervention such as the attitudes toward asthma care of the subjects and the personal social support perceived by the subjects
Our previous NHLBI-supported study HL 57232 showed that a combination treatment of Coaching through follow-up phone calls 2 and 5 days following an index ED visit plus monetary incentive was highly effective in increasing the percentage of low-income urban children who received recommended primary care within 2 weeks of the ED visit for asthma 44 in the intervention group vs 29 in usual care p 00004 However the intervention was not associated with significant differences in morbidity subsequent ED visits We conclude that the intervention was effective in promoting the initial link to primary care but was not effective in sustaining that link or management practices to minimize acuity of symptoms during exacerbation
DESIGN NARRATIVE
Primary outcome The proportion of children of subjects in each group who have at least one ED visit for acute asthma symptoms during the thirty-six month period following enrollment
Key secondary outcomes A The proportion of children of subjects in each group who are hospitalized during the thirty-six month period following enrollment
B The proportion of children of subjects in each group who have either acute asthma visits or asthma-planning visits with their primary care providers
C The costs of asthma-related care during the thirty-six month period D Variables which may mediate or moderate the intervention such as the attitudes toward asthma care of the subjects and the personal social support perceived by the subjects
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 |
|---|---|---|---|
| R01HL072919 | NIH | None | httpsreporternihgovquickSearchR01HL072919 |