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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaching
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion 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. Exclusion 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.

Sites / Locations

  • Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coaching group for lifestyle changes

Routine pediatric care

Arm Description

Patients received monthly phone calls with coaching for lifestyle changes over 2 years.

This group receives routine care with their pediatrician.

Outcomes

Primary Outcome Measures

ER visits
Documenting the number of ER visits per patient in the 18 month period.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
May 2, 2018
Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00149500
Brief Title
Social Support and Education in Asthma Follow-up (SSEA)
Acronym
SSEA
Official Title
Social Support and Education in Asthma Follow-up (SSEA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 = 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coaching group for lifestyle changes
Arm Type
Experimental
Arm Description
Patients received monthly phone calls with coaching for lifestyle changes over 2 years.
Arm Title
Routine pediatric care
Arm Type
No Intervention
Arm Description
This group receives routine care with their pediatrician.
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Intervention Description
Patients received monthly calls to assist in behavioral change relative to asthma care
Primary Outcome Measure Information:
Title
ER visits
Description
Documenting the number of ER visits per patient in the 18 month period.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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. Exclusion 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Strunk
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21646584
Citation
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.
Results Reference
derived

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

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