The Development and Pilot Testing of a Caregiver-Child Shared Decision-Making Intervention to Improve Asthma in Urban Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- Mean Asthma Control Questionnaire Score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patient participants, data collectors, and the statistician will be blinded to assignment. Consent materials will inform patient participants that the focus of the trial is on the communication they have with their clinician about asthma management and control. Immediately after the intervention, patient participants will be asked to guess the condition to which their clinician had been randomized. At the end of participants' final data collection visit, data collectors will be asked to guess whether participants had received the active or control intervention at the visit. These data will provide some measurement of the success of masking.
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(Dyad participants):
- •Non-English speaking
- •Serious mental health conditions that preclude completion of study procedures or confound analyses or participation in a listening session
研究组 & 干预措施
BREATHE-Peds intervention
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.
干预措施: BREATHE-Peds Intervention (Behavioral)
Control Intervention
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.
干预措施: Control Intervention (Behavioral)
结局指标
主要结局
Mean Asthma Control Questionnaire Score
时间窗: Up to 3 months post intervention
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.
次要结局
- Mean Shared Decision Making-Questionnaire-9 Score(Baseline (immediately post-intervention))
- Mean Medication Adherence Report Scale - Asthma Score(Up to 3 months post intervention)
- Mean Asthma Quality of Life Questionnaire Score(Up to 3 months post intervention)
- Mean Asthma Impairment and Risk Questionnaire Score(Up to 3 months post intervention)
研究者
Maureen George
Professor of Nursing, Columbia University Irving Medical Center
Columbia University