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临床试验/NCT04089046
NCT04089046招募中不适用

Telemedicine Enhanced Asthma Management - Uniting Providers for Teens

University of Rochester2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2021年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
360
试验地点
2
主要终点
Mean Symptom Free Days in prior 14 days

研究概览

简要总结

Low-income, minority teenagers have disproportionately high rates of asthma morbidity, including excess risk of emergency department visits, hospitalizations, and death from asthma. Despite well established guidelines, under-treatment for asthma is common, particularly for poor urban teens. This study aims to test a novel, developmentally appropriate and scalable model of care to ensure optimal guideline-based treatment for urban teens with difficult to control asthma. The Telemedicine Enhanced Asthma Management-Uniting Providers for Teens (TEAM-UP for Teens) program includes 3 core components: 1- An individualized asthma management plan developed at the start of the school year via a real-time, synchronous school-based telemedicine visit that directly connects the teen to an asthma specialist, 2- School-based or video supported directly observed therapy (DOT) to implement the medication plan and allow for teens to experience the benefits of consistent therapy, 3- Follow-up telehealth visits with a nurse asthma educator to facilitate ongoing care and provide developmentally appropriate self-management support. This study is a randomized trial of TEAM-UP for Teens vs an enhanced care (EC) control group (n=360, 12-16 years). We will assess the effectiveness of the program in reducing morbidity and improving guideline-based asthma care. Our main hypothesis is that Teens receiving the TEAM-UP for Teens intervention will have more symptom-free days at 3, 5, 7, and 12-months compared to EC. We will assess a number of secondary outcomes, including additional clinical outcomes, functional outcomes, airway inflammation, and receipt of specific care measures including medication adjustments and treatment of and other comorbidities. We will also identify potential mediators and moderators of the intervention effect, and will evaluate the process of intervention implementation. At the completion of the study, the program will be better defined as a sustainable means to improve care and reduce morbidity for high risk teens with difficult to control asthma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Physician-diagnosed asthma (based on caregiver report with validation from teen's physician).
  • Moderate-severe persistent severity (requiring Step 3 or higher care) or asthma that is uncontrolled despite therapy
  • Age >=12 and =<17 years
  • Residence in the City of Rochester and surrounding metro area.

排除标准

  • Inability to speak and understand either English or Spanish. (*Participants unable to read will be eligible, and all instruments will be given verbally.)
  • Current participation in an asthma study
  • Planning to move outside of Rochester in less than 6 months
  • If they have received asthma specialist care in the prior 3 months, they will be asked if they would be comfortable seeing an additional asthma specialist for our study if their current specialist is unable to participate in the study. If the family is not comfortable with seeing an additional asthma specialist for the study, they will be excluded.
  • Having other significant medical conditions (congenital heart disease, cystic fibrosis, other chronic lung disease) that could interfere with the assessment of asthma-related measures
  • In foster care or other situations in which consent cannot be obtained from a guardian

研究组 & 干预措施

TEAM-UP for Teens Intervention

Experimental

TEAM-UP for Teens pairs school-based and video-supported directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school.

干预措施: TEAM-UP for Teens (Behavioral)

Enhanced Care Comparison

Active Comparator

Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits.

干预措施: Enhanced Care (EC) (Behavioral)

结局指标

主要结局

Mean Symptom Free Days in prior 14 days

时间窗: 12-month

Mean Symptom Free Days will be calculated as a mean using data collected at 3-, 5-, 7- and 12-months post baseline. Caregivers and teens will report the number of days the teen experienced no symptoms of asthma (defined as 24 hrs with no coughing, wheezing, shortness of breath, and no need for rescue medicine) in the past 2 weeks (range 0-14).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Halterman

Professor

University of Rochester

研究点 (2)

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