Breathe With Ease: A Unique Approach to Managing Stress (BEAMS)

NCT02374138 | Completed Results DMC

• 1 other identifier: 5819
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

Uncontrolled asthma in at-risk youth responds well to guideline-based therapy when patients remain adherent to their management plans. Adherence to inhaled corticosteroids (ICS), when indicated for persistent or uncontrolled asthma, is a critical component of most asthma management plans, and other self-management practices such as trigger avoidance are similarly related to improved asthma outcomes. Adherence to self-management practices is mediated by multiple factors, including psychosocial stress of parents and their children. A targeted, culturally appropriate intervention to manage psychosocial stress among the parents of young, African American, and socioeconomically disadvantaged urban children with asthma who are receiving guideline-based care may improve asthma self-management, and therefore asthma outcomes. Our overall aim is to implement and evaluate a highly collaborative, multi-dimensional, culturally appropriate and community-based asthma intervention to augment existing guideline-based best practice. The intervention will target the parents of at-risk, urban, African American youth, and will employ individualized psychosocial stress management and peer support.

Conditions

Asthma

Keywords

psychosocial stress

Outcome Measures

Primary Outcomes (1)

• Symptom-free Days in the Last 14 Days

  Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications

  Repeated Measures at 6 months (3 month data collected to allow for repeated measures)

Secondary Outcomes (19)

• Asthma Morbidity - Nighttime Asthma Symptoms

  Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

• Asthma Severity and Control

  Repeated Measures at 3, 6, and 12 months

• Asthma Medication Adherence

  Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

• Health Care Utilization - Emergency Department Visits for Asthma

  12 months after enrollment

• Asthma Exacerbations - Courses of Systemic Steroids

  Assessed at 6m and 12m following enrollment

Other Outcomes (8)

• Sociodemographics

  Baseline

• Number of Participants With Positive Smoke Exposure

  Repeated Measures at 6 and 12 months (3m data collected for repeated measures)

• Parental Health Literacy

  Baseline

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Other: Usual Care

Intervention

EXPERIMENTAL

Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.

Behavioral: Parental stress management

Interventions

Parental stress management BEHAVIORAL

The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by "community wellness coaches."

Intervention

Usual Care OTHER

IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Usual Care

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• self-identify as African-American
• both the legal guardian and primary asthma caregiver of an eligible child.

You may not qualify if:

• unable or unwilling to sign informed consent document
• enrolled in another asthma research study.
• parent-identified as African-American
• age 4-12 years inclusive at recruitment
• physician diagnosis of persistent asthma
• publicly financed insurance
• \- chronic medical condition (other than asthma) including but not limited to diabetes, sickle cell disease, heart disease, lung disease or neurological disorder.
• In addition, the PI may choose to not include a participant if he does not believe it is in the family's best interest to participate.

Sponsors & Collaborators

• Stephen J. Teach, MD, MPH: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• Teach SJ, Shelef DQ, Foushee N, Horn IB, Yadav K, Wang Y, Rand CS, Streisand R. Randomized clinical trial of parental psychosocial stress management to improve asthma outcomes. J Asthma. 2021 Jan;58(1):121-132. doi: 10.1080/02770903.2019.1665063. Epub 2019 Sep 23.

  PMID: 31545115 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Stephen Teach, MD, MPH
• Organization: Children's Research Institute

steach@childrensnational.org

202 476 5134

Study Officials

• Stephen Teach, MD, MPH

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Pediatrics

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 27, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: May 1, 2017
• Last Updated: September 23, 2019
• Results First Posted: September 23, 2019

Record last verified: 2019-08

Locations

US (1)