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Teen Asthma Control Encouraging a Healthier Lifestyle (TAC)

2018年8月2日 更新者:Christine Joseph、Henry Ford Health System

Developing Patient-Centered Approaches to Asthma Management in Obese Adolescents

Little guidance is given to physicians caring for obese adolescents with asthma, however, findings suggest that interventions designed to achieve asthma control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g., low self-esteem, depression, and low quality of life) successful interventions should incorporate a patient-centered approach. The proposed study design is a clinic-based, randomized controlled trial (RCT) in teens with a history of asthma and who are overweight or obese.

研究概览

详细说明

Asthma that has persisted in adolescents is likely to persist into adulthood. For 25-30% of Americans, adolescence is also the period at which they experience their greatest weight gain, particularly as they approach the final stages of puberty. Asthma management may be more of a challenge in the overweight adolescent compared to a normal weight youth. Asthma related morbidity is increased in overweight patients, reflected in higher health care utilization for this subgroup. Little guidance is given to physicians caring for obese adolescents with asthma, but findings suggest that interventions designated to achieve control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g. low self-esteem, depression and low quality of life) successful interventions should incorporate a patient-centered approach.

Patient-centered care (or patient focused care) involves a partnership between the patient and the physician, shared discussion making, as well as productive communication and health promotion. The objective of this project is to collect the information necessary to develop a tailored discussion guide for use by the physician caring for the obese teen with asthma. Project results will provide an evidence base for the development and evaluation of additional patient-centered health interventions for obese adolescents with asthma. The investigators will conduct this study among patients whom eligibility can be determined using the electronic medical record (EMR). The specific aims of this proposal are to:

Qualitatively collect information on outcomes important to obese adolescents with asthma:

Create a tailored discussion guide that incorporates patient preferences and treatment goals that can be used by providers caring for overweight adolescents with asthma:

Conduct a randomized trial to determine if patient-centered and clinical outcomes improve for patients whose physicians use the tailored discussion guide compared to those who do not.

研究类型

介入性

注册 (实际的)

44

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Michigan
      • Detroit、Michigan、美国、48202
        • Henry Ford System

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 19年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • BMI >85th Percentile & Diagnosed with asthma; using a modification of Healthcare Effectiveness Data and Information Set (HEDIS) criteria:
  • At least one emergency department visit with a principal diagnosis of asthma, or
  • At least one acute inpatient claim/encounter with asthma as the principal diagnosis or at least four outpatient visits with an asthma diagnosis and at least or
  • At least four asthma four outpatient visit with an asthma diagnosis and at least two asthma medications dispensed, or
  • At least four asthma medications dispensed in the last 12 month

Exclusion Criteria:

  • Does not meet eligibility criteria for weight and/or asthma;
  • Currently enrolled in another investigational asthma management /education/weight management trial.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Standard Control
Teens in the control group will receive standard or usual care as provided by their physician.
Teens in the control group will receive standard or usual care as provided by their physician.
其他:Intervention
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Asthma Control Test
大体时间:12 months of enrollment
A validated measure of asthma control
12 months of enrollment

次要结果测量

结果测量
措施说明
大体时间
Body Mass Index (BMI)
大体时间:12 months of enrollment
changes in participant weight
12 months of enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Christine Joseph, PhD、Henry Ford Health System

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年8月1日

初级完成 (实际的)

2018年2月1日

研究完成 (实际的)

2018年2月1日

研究注册日期

首次提交

2015年10月12日

首先提交符合 QC 标准的

2015年10月13日

首次发布 (估计)

2015年10月14日

研究记录更新

最后更新发布 (实际的)

2018年8月6日

上次提交的符合 QC 标准的更新

2018年8月2日

最后验证

2018年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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