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

22 augusti 2019 uppdaterad av: Stephen J. Teach, MD, MPH

Improving Asthma Outcomes Through Stress Management

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

217

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20010
        • Children's National Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

4 år till 12 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Usual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Övrig: Usual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Experimentell: Intervention
Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.
Beteende: 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."

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Symptom-free Days in the Last 14 Days
Tidsram: Repeated Measures at 6 months (3 month data collected to allow for repeated measures)
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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Asthma Morbidity - Nighttime Asthma Symptoms
Tidsram: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Nights of asthma symptoms in prior 14d
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Asthma Severity and Control
Tidsram: Repeated Measures at 3, 6, and 12 months
Repeated Measures at 3, 6, and 12 months
Asthma Medication Adherence
Tidsram: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Reported use of inhaled corticosteroids and LTRA in past two days
Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
Health Care Utilization - Emergency Department Visits for Asthma
Tidsram: 12 months after enrollment
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
Asthma Exacerbations - Courses of Systemic Steroids
Tidsram: Assessed at 6m and 12m following enrollment
Courses of systemic steroids over 12m follow up period
Assessed at 6m and 12m following enrollment
Parental Stress
Tidsram: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
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)
Parental Depression
Tidsram: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
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)
Child Anxiety
Tidsram: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
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)
Child Depression
Tidsram: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
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)
Caregiver Quality of Life
Tidsram: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
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)
Number of Participants With AEs and SAEs
Tidsram: 12m follow up period
Safety data: Number of Participants with AEs and SAEs
12m follow up period
Economic Outcomes
Tidsram: 12m follow-up period
Analysis of costs of care in both groups
12m follow-up period
Caregiver Smoking Behavior
Tidsram: Repeated Measures at 6 and 12 months
parent report of cigarettes smoked per day
Repeated Measures at 6 and 12 months
Coping Strategies
Tidsram: Repeated measures at 12m FU (6m data used for repeated measures)
Brief COPE
Repeated measures at 12m FU (6m data used for repeated measures)
Mindfulness
Tidsram: Repeated Measures at 6 and 12 months
Interpersonal Mindfulness in Parenting
Repeated Measures at 6 and 12 months
Parental Resilience
Tidsram: Repeated Measures at 6 and 12 months
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
Exacerbations - Hospital Admissions
Tidsram: Assessed at 6m and 12m after enrollment
Number of participants with hospital admissions due to exacerbations
Assessed at 6m and 12m after enrollment
Symptom-free Days in the Last 14 Days
Tidsram: Repeated Measures at 12 months (with data also assessed at 3m and 6m)
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)
Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use
Tidsram: Repeated measures at 6 and 12 months (3m data collected for repeated measures)
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)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sociodemographics
Tidsram: Baseline
Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
Baseline
Number of Participants With Positive Smoke Exposure
Tidsram: Repeated Measures at 6 and 12 months (3m data collected for repeated measures)
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)
Parental Health Literacy
Tidsram: Baseline
Single Item Literacy Screener (SILS)
Baseline
Use of Existing Ancillary Services
Tidsram: Assessed at 6m and 12m following enrollment
Assessed at 6m and 12m following enrollment
Parental Resilience
Tidsram: Baseline
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
Intervention Component Uptake
Tidsram: 6 month intervention period
Completion of intervention sessions
6 month intervention period
Intervention Satisfaction
Tidsram: 6 month intervention period
Brief survey of satisfaction with intervention components.
6 month intervention period
Intervention Fidelity
Tidsram: 6 month intervention period
Checklist of staff's fidelity to individual components of intervention protocol
6 month intervention period

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Stephen J. Teach, MD, MPH

Samarbetspartners

Patient-Centered Outcomes Research Institute

Utredare

  • Huvudutredare: Stephen Teach, MD, MPH, Children's National Health System

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2015

Primärt slutförande (Faktisk)

1 november 2016

Avslutad studie (Faktisk)

1 maj 2017

Studieregistreringsdatum

Först inskickad

10 februari 2015

Först inskickad som uppfyllde QC-kriterierna

26 februari 2015

Första postat (Uppskatta)

27 februari 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 augusti 2019

Senast verifierad

1 augusti 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 5819

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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