Social Support and Education in Asthma Follow-up (SSEA)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00149500
First received: September 6, 2005
Last updated: July 1, 2008
Last verified: July 2008

September 6, 2005
July 1, 2008
September 2003
May 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00149500 on ClinicalTrials.gov Archive Site
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Social Support and Education in Asthma Follow-up (SSEA)
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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.

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 = 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.

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 .

Interventional
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Allocation: Randomized
Primary Purpose: Treatment
Asthma
Behavioral: Coaching
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Nelson KA, Highstein GR, Garbutt J, Trinkaus K, Fisher EB, Smith SR, Strunk RC. A randomized controlled trial of parental asthma coaching to improve outcomes among urban minority children. Arch Pediatr Adolesc Med. 2011 Jun;165(6):520-6. doi: 10.1001/archpediatrics.2011.57.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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May 2008
May 2008   (final data collection date for primary outcome measure)

The parent/caregiver is the subject of this study and will be included based on the following criteria:

A. The child of the parent/caregiver has a diagnosis of asthma made by a physician and reported by the parent, or diagnosis of asthma made during the ED visit if the child has experienced two previous wheezing episodes.

B. The child will undergo treatment during the enrollment ED visit for the current asthma exacerbation, as determined by the treating ED clinician. As a result, only parents/caregivers with children experiencing a significant wheezing episode will be entered into the study.

C. The child is 2-10 years of age (second birth date until, but not including, eleventh birth date).

D. The child has Medicaid or no medical insurance. This criterion permits easy identification and selection of low-income children/families, who are the target population for this proposal.

E. The parent/caregiver has a working telephone at home. F. The child attends one of the target practices (7 private practices and 5 federally funded clinics) for routine care.

G. The parent/caregiver and child live within the St. Louis metro area.

The parent/caregiver is the subject of this study and will be excluded based on the following criteria:

A. The child attends a practice other than the target group. B. The parent/caregiver and child live outside of the St. Louis metro area. C. The child has a chronic illness other than asthma that manifests as wheezing or respiratory symptoms.

D. The parent/caregiver does not have a working telephone in home. E. The parent/caregiver is not able to effectively communicate in English.

Both
2 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00149500
259
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Robert Strunk Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP