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临床试验/NCT02860390
NCT02860390已完成不适用

Denver Health Asthma Management Program

Denver Health and Hospital Authority0 个研究点目标入组 154 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
主要终点
Mean Asthma Control Test Score

研究概览

简要总结

This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old individuals with persistent asthma comparing differing levels of texting interventions with each other and with a usual care group. The two texting interventions include 1) texting only the individual with asthma and 2) texting the individual with asthma and an important person in that individual's life such as a parent or spouse. These two texting groups will be compared to a group receiving usual asthma care at Denver Health.

详细描述

This is Phase 2 of a two-phase pilot project to build and study a texting program for patients at Denver Health who have persistent asthma. The overall goal of the program is to provide educational support for asthma care between clinic visits and to survey for evidence of poorly controlled asthma, which would prompt clinic recall. Phase 1 used a focus group/interview methodology to inform Phase 2 and allow Phase 2 to be more patient-centered. Based on results of focus groups/interviews, the investigators will conduct a three-arm trial among 13- to 19-year-olds and a two-arm trial among 20- to 40-year-olds. For the 13- to 19-year-old group, a 'usual care' group will be compared to two intervention groups: 1) a subject group receiving text messages about asthma care and 2) a group of subjects and their 'significant other', such as a parent, who will also receive the text messages. Overall, Phase 1 findings suggested the 20- to 40-year-old group was more reluctant to involve a significant other and therefore for this group a 'usual care' arm will be compared to an arm where only the patient receives the text messages, but not a significant other. Other features built into Phase 2 upon recommendation from the focus group/interview phase include a midpoint survey and tailoring the amount of texting a patient receives based on the level of asthma control elicited by administration of the validated tool, the Asthma Control Test (ACT).

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
None

入排标准

年龄范围
13 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subject and significant other as applicable must have phone or other device capable of receiving text messages
  • Ages 13 to 19 with persistent asthma per Denver Health electronic health record and/or HEDIS (modified) criteria for asthma
  • Ages 20 to 40 with HEDIS (modified) criteria for persistent asthma
  • Hospital-based utilization for asthma (i.e. persistent asthma)
  • Denver Health Primary Care Provider visits within last 3 years
  • Ability to read English or Spanish.

排除标准

  • complex and special health care needs pediatric patients
  • pregnant/expectant mothers
  • incarcerated individuals
  • Non-English and non-Spanish speakers
  • Chronic Obstructive Pulmonary Disease/COPD or other non-asthma pulmonary diagnoses (e.g. pulmonary function testing inconsistent with asthma and/or negative methacholine challenge testing/lack of reversibility with β-agonist, diagnostic errors despite inclusion in the Asthma Registry)
  • Patients who by input of the primary care provider are less likely to participate in an interactive asthma text messaging trial (e.g. intellectual delay, mental health issues)

结局指标

主要结局

Mean Asthma Control Test Score

时间窗: Six months

次要结局

  • Asthma-related utilization - Emergent Care(Six months)
  • Asthma-related utilization - Hospitalization(Six months)
  • Asthma-related utilization - Urgent Care(Six months)
  • Quality of Life(Six months)
  • Medication Adherence(Six months)
  • Pre/Post Comparison of Asthma Control Test score(Six months)

研究者

申办方类型
Other
责任方
Sponsor

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