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

22 sierpnia 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

217

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • District of Columbia
      • Washington, District of Columbia, Stany Zjednoczone, 20010
        • Children's National Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

4 lata do 12 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Usual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Inny: Usual Care
IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
Eksperymentalny: Intervention
Parental stress management in addition to IMPACT DC intervention of guideline-based clinical care, education, and short-term care coordination.
Behawioralne: 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."

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Symptom-free Days in the Last 14 Days
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Asthma Morbidity - Nighttime Asthma Symptoms
Ramy czasowe: 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
Ramy czasowe: Repeated Measures at 3, 6, and 12 months
Repeated Measures at 3, 6, and 12 months
Asthma Medication Adherence
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 12m follow up period
Safety data: Number of Participants with AEs and SAEs
12m follow up period
Economic Outcomes
Ramy czasowe: 12m follow-up period
Analysis of costs of care in both groups
12m follow-up period
Caregiver Smoking Behavior
Ramy czasowe: Repeated Measures at 6 and 12 months
parent report of cigarettes smoked per day
Repeated Measures at 6 and 12 months
Coping Strategies
Ramy czasowe: 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
Ramy czasowe: Repeated Measures at 6 and 12 months
Interpersonal Mindfulness in Parenting
Repeated Measures at 6 and 12 months
Parental Resilience
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Sociodemographics
Ramy czasowe: Baseline
Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history
Baseline
Number of Participants With Positive Smoke Exposure
Ramy czasowe: 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
Ramy czasowe: Baseline
Single Item Literacy Screener (SILS)
Baseline
Use of Existing Ancillary Services
Ramy czasowe: Assessed at 6m and 12m following enrollment
Assessed at 6m and 12m following enrollment
Parental Resilience
Ramy czasowe: 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
Ramy czasowe: 6 month intervention period
Completion of intervention sessions
6 month intervention period
Intervention Satisfaction
Ramy czasowe: 6 month intervention period
Brief survey of satisfaction with intervention components.
6 month intervention period
Intervention Fidelity
Ramy czasowe: 6 month intervention period
Checklist of staff's fidelity to individual components of intervention protocol
6 month intervention period

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Stephen J. Teach, MD, MPH

Współpracownicy

Patient-Centered Outcomes Research Institute

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 maja 2015

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2016

Ukończenie studiów (Rzeczywisty)

1 maja 2017

Daty rejestracji na studia

Pierwszy przesłany

10 lutego 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 lutego 2015

Pierwszy wysłany (Oszacować)

27 lutego 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 września 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 sierpnia 2019

Ostatnia weryfikacja

1 sierpnia 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 5819

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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