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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Coaching

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 .

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Coaching group for lifestyle changes; Patients received monthly phone calls with coaching for lifestyle changes over 2 years.	Behavioral: Coaching; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ER visits	Documenting the number of ER visits per patient in the 18 month period.	18 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Robert Strunk, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (ACTUAL): May 1, 2008
• Study Completion (ACTUAL): May 1, 2008

Study Registration Dates

• First Submitted: September 6, 2005
• First Submitted That Met QC Criteria: September 6, 2005
• First Posted (ESTIMATE): September 8, 2005

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 259; R01HL072919 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO