Social Support and Education in Asthma Follow-up (SSEA) (SSEA)
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|ClinicalTrials.gov Identifier: NCT00149500|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : May 8, 2018
We will evaluate the effect of an eighteen-month asthma coaching intervention for parents/caregivers 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 (parents/caregivers) 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 children's asthma and improving interactions with the primary care providers for their children.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Coaching||Not Applicable|
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 = 0.0004). 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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||241 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Social Support and Education in Asthma Follow-up (SSEA)|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Experimental: Coaching group for lifestyle changes
Patients received monthly phone calls with coaching for lifestyle changes over 2 years.
Patients received monthly calls to assist in behavioral change relative to asthma care
No Intervention: Routine pediatric care
This group receives routine care with their pediatrician.
- ER visits [ Time Frame: 18 months ]Documenting the number of ER visits per patient in the 18 month period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149500
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Robert Strunk||Washington University School of Medicine|