BREATHE-Peds Pilot- II III Trial and Post Trial

Study Overview
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Brief Summary
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The overall aims of this study are to develop and pilot test BRief intervention to Evaluate Asthma THErapy (BREATHE)-Peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in federally-qualified health centers (FQHCs) in urban communities. Aim 1 (Phase I) involves developing the intervention through focus groups with early adolescents and caregivers. Aims 2 and 3 (Phase II) involve preliminary testing of the intervention through a pilot randomized controlled trial. This record is for Phase II and III only

Detailed Description
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Despite high asthma prevalence and morbidity among adolescents (highest among Black and Hispanic youth and early adolescents aged 10-14), there is a lack of developmentally appropriate interventions for this at-risk group. Racial and ethnic minority early adolescents have sub-optimal asthma self-management. Critical health behaviors that emerge during early adolescence affect lifelong patterns; therefore, early adolescence offers a unique opportunity to intervene. Additionally, successful self-management requires the right division of responsibility between adolescents and their caregivers. Thus, intervening simultaneously with early adolescents and their caregivers who can help support the adolescent's growing autonomy to self-manage their condition has the potential for a synergistic effect. Prior studies have demonstrated the effects of improved asthma control of BREATHE, a brief one-time shared decision-making intervention for Black adults with uncontrolled asthma that utilizes motivational interviewing delivered by primary care providers. This study (i.e., Phase II and Phase III) ) a pilot validation phase will conduct a group-randomized trial in two FQHCs with 85 dyads treated by 8 PCPs (10 dyads/PCP) randomized to 1 of 2 study arms: (a) BREATHE-PEDS-Peds (n=42 dyads), or (b) dose-matched attention control (n=43 dyads). Post-trial interviews with PCPs, caregivers, and their children to evaluate satisfaction with the intervention will be conducted; caregiver-child dyads will be followed for 3 months post-intervention to assess the impact of BREATHE-PEDS-Peds on asthma outcomes.

Official Title
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The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth

Conditions
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Asthma in Children

Intervention / Treatment
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* Behavioral: BREATHE-Peds Intervention
* Behavioral: Control Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Dyad participants): Dyad (caregiver/child) participants will Early adolescents (10-14 years of age) or the caregiver of early adolescents (10-14 years of age) Have or the caregiver of a child that has clinician-diagnosed persistent asthma (defined as being prescribed inhaled corticosteroids in the last 12 months) Receive asthma care at a partner FQHC and Child screens positive for uncontrolled asthma as measured by the Asthma Control Questionnaire- 6 items (ACQ-6) and child or caregiver has erroneous beliefs as measured by the Conventional and Alternative Management for Asthma (CAM-A) survey. Inclusion Criterion (clinicians): 1. Those who manage a panel of pediatric asthma patients at partner FQHC. Exclusion Criteria (Dyad participants): Non-English speaking Serious mental health conditions that preclude completion of study procedures or confound analyses or participation in a listening session

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BREATHE-Peds intervention<br>The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit. | Behavioral: BREATHE-Peds Intervention<br>* BREATHE-Peds utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).<br>|
| Active Comparator: Control Intervention<br>The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control. | Behavioral: Control Intervention<br>* The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Asthma Control Questionnaire Score | Asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) score, a 6-item validated and widely used measure of asthma control. Each question is rated from 0 to 6. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. The overall ACQ score is the mean score of all 6 items with scores ranging from 0 to 6. Lower mean scores indicate greater asthma control (better outcome), higher mean scores indicate lesser asthma control. | Up to 3 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Shared Decision Making-Questionnaire-9 Score | The Shared Decision Making (SDM) Questionnaire-9, is a patient reported, 9-item validated instrument that consists of nine statements that measure the decisional process in medical visits from both patients' and physicians' perspectives. Each statement is rated on a six-point scale from completely disagree (0) to completely agree (5). The raw total score of all items range from 0-45. Lower scores indicate lower levels of shared decision making between provider and patient (in this study as it pertains to asthma treatment) and higher scores indicate higher levels of shared decision making (better outcome). | Baseline (immediately post-intervention) | 
| Mean Medication Adherence Report Scale - Asthma Score | Inhaled corticosteroid adherence as measured by the Medication Adherence Report Scale - Asthma (MARS-A). Participants are asked to rate the frequency with which they engage in each of the adherence-related behaviors on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item are summed to give a total score, with higher scores indicating higher levels of reported adherence. | Up to 3 months post intervention | 
| Mean Asthma Quality of Life Questionnaire Score | Asthma quality of life improvements as measured by the Asthma Quality of Life Questionnaire (AQLQ), a 32-item validated and widely-used measure consisting of 4 domains: symptoms (11 items), emotions (5 items), environment (4 items), and activities (12 items). Each item is measured on a 7-point Likert scale (7 = not impaired at all, 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. Lower mean scores indicate lower quality of life due to asthma (worse outcome). | Up to 3 months post intervention | 
| Mean Asthma Impairment and Risk Questionnaire Score | Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item valid and reliable survey that measures bot domains of control: symptom impairments and risk for uncontrolled asthma. AIRQ™ score ranges from 0-10, measured by total number of YES answers. Scores range from 0 to 10, with lower scores indicating a better outcome. Score tally of 0-1 indicates well controlled asthma, scores 2-4 indicate not well controlled asthma, and scores 5-10 indicate very poorly controlled asthma. | Up to 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Adolescents, Dyads, Shared decision-making, Minority health