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

Asthma Clinical Trial

Official title:

Improving Asthma Outcomes Through Stress Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374138
• Other study ID #: 5819
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: August 2019
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

We will conduct a single blind, prospective randomized controlled trial comparing the IMPACT DC Asthma Clinic's existing intervention of guideline-based clinical care, education, and short-term care coordination (usual care) to usual care plus parental stress management in a cohort of up to 200 parent-child dyads of AA youth aged 4-12 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: May 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

We plan to enroll parent-child dyads that meet the following criteria:

Inclusion criteria (Parent):

• self-identify as African-American

• both the legal guardian and primary asthma caregiver of an eligible child.

Exclusion criteria (Parent):

• unable or unwilling to sign informed consent document

• exclusionary psychiatric condition, including but not limited to psychosis, based on the screening form at recruitment

• enrolled in another asthma research study.

Inclusion criteria (Child):

• parent-identified as African-American

• age 4-12 years inclusive at recruitment

• physician diagnosis of persistent asthma

• publicly financed insurance

Exclusion criteria (Child):

• 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Parental stress management
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."

Other:
• Usual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Stephen J. Teach, MD, MPH	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographics	Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history	Baseline
Other	Number of Participants With Positive Smoke Exposure	Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: "How often did anyone smoke inside the home where child usually lives?" or "How often did anyone smoke in the room where child usually sleeps?" A positive response on either or both questions was considered positive exposure.	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Other	Parental Health Literacy	Single Item Literacy Screener (SILS)	Baseline
Other	Use of Existing Ancillary Services		Assessed at 6m and 12m following enrollment
Other	Parental Resilience	Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.	Baseline
Other	Intervention Component Uptake	Completion of intervention sessions	6 month intervention period
Other	Intervention Satisfaction	Brief survey of satisfaction with intervention components.	6 month intervention period
Other	Intervention Fidelity	Checklist of staff's fidelity to individual components of intervention protocol	6 month intervention period
Primary	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	Asthma Morbidity - Nighttime Asthma Symptoms	Nights of asthma symptoms in prior 14d	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Secondary	Asthma Severity and Control		Repeated Measures at 3, 6, and 12 months
Secondary	Asthma Medication Adherence	Reported use of inhaled corticosteroids and LTRA in past two days	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Secondary	Health Care Utilization - Emergency Department Visits for Asthma	Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere	12 months after enrollment
Secondary	Asthma Exacerbations - Courses of Systemic Steroids	Courses of systemic steroids over 12m follow up period	Assessed at 6m and 12m following enrollment
Secondary	Parental Stress	Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress.	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Secondary	Parental Depression	Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms.	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Secondary	Child Anxiety	PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Secondary	Child Depression	PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Secondary	Caregiver Quality of Life	Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed.	Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Secondary	Number of Participants With AEs and SAEs	Safety data: Number of Participants with AEs and SAEs	12m follow up period
Secondary	Economic Outcomes	Analysis of costs of care in both groups	12m follow-up period
Secondary	Caregiver Smoking Behavior	parent report of cigarettes smoked per day	Repeated Measures at 6 and 12 months
Secondary	Coping Strategies	Brief COPE	Repeated measures at 12m FU (6m data used for repeated measures)
Secondary	Mindfulness	Interpersonal Mindfulness in Parenting	Repeated Measures at 6 and 12 months
Secondary	Parental Resilience	Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.	Repeated Measures at 6 and 12 months
Secondary	Exacerbations - Hospital Admissions	Number of participants with hospital admissions due to exacerbations	Assessed at 6m and 12m after enrollment
Secondary	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 12 months (with data also assessed at 3m and 6m)
Secondary	Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use	Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d	Repeated measures at 6 and 12 months (3m data collected for repeated measures)