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临床试验/NCT01714141
NCT01714141已完成不适用

Multi-Component Technology Intervention for Minority Emerging Adults With Asthma

Wayne State University0 个研究点目标入组 48 人开始时间: 2011年12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
48
主要终点
Change in medication adherence

研究概览

简要总结

This pilot study's main goal is to develop and preliminarily test a technology-based intervention to improve asthma medication adherence in urban African American emerging adults (ages 18-29). It is hypothesized that youth randomized to MCTI for adherence will show improvements in motivation to adhere to asthma medications and self-reported adherence compared to the comparison condition at 1- and 3- month follow up.

详细描述

This study collected pilot data with a sample of 48 African American emerging adults with asthma with suboptimal medication adherence. Half of the sample were randomized to receive a multi-component technology-based intervention (MCTI) targeting adherence to daily controller medication. The MCTI consisted of two components: 1) 2 sessions of computer-delivered motivational interviewing targeting medication adherence, and 2) individualized text messaging focused on medication adherence between the sessions. Text messages were individualized based on Ecological Momentary Assessment (EMA). The remaining half of participants completed a series of computer-delivered asthma education modules matched for length, location, and method of delivery of the intervention session. Control participants also received text messages between intervention sessions. Message content was the same for all control participants and contain general facts about asthma (not tailored).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • African American Live in the Detroit Area, approximately 30 miles from the Hutzel Building Ages 18-29
  • Have moderate to severe persistent asthma. Persistent asthma is defined according to the 2007 NHLBI guidelines. The level of symptoms, as defined by any of the following in the last 4 weeks:
  • Use of any asthma medication more than 2 times a week Daytime asthma symptoms such as wheezing, tightness of chest, problems coughing more than 2 times a week, or waking up at night because of asthma more than 2 times a month
  • Participant is prescribed a daily asthma controller medication, even if they do not take it.
  • Participant must report poor adherence to daily controller medications during eligibility screening (brief interview).
  • Poor adherence is defined as not taking medications "as prescribed" less than 4 days per week in any of the 4 weeks prior to enrollment OR as a proxy of poor adherence as self-report of <80% medication adherence in the past 30 days, self-report of emergency room visit/hospitalization for asthma in the past 6 months, or a poor score on the Asthma Control Test.
  • Participant must be able to complete questionnaires in English Participant must own or have access to a cellular phone for the duration of the study No exclusions will be made due to co-morbid mental health problems (i.e. ADHD, depression) except thought disorders (i.e. schizophrenia, autism), suicidality or mental retardation.

排除标准

  • Individuals with other chronic health conditions requiring ongoing medical intervention ( e.g., HIV, Type II Diabetes) will be excluded.
  • These chronic diseases include: Glaucoma, bi-polarism, segmented glomerular nephritis, cystic fibrosis, spondyloarthropathy, congenital heart disease, sickle cell
  • No pregnant women will be included in this study.

结局指标

主要结局

Change in medication adherence

时间窗: baseline, 1 month, 3 month

Self-reported adherence to asthma controller medication(s) through questionnaire report and, at baseline and 3 months, 7 days of momentary (real time) sampling of adherence behavior via SMS text messaging.

Change in motivation for medication adherence

时间窗: baseline, 1 month, 3 month

Self-report of motivation to take asthma controller medications as prescribed.

次要结局

  • Change in barriers to taking medication(baseline, 1 month, 3 months)
  • Change in asthma self-efficacy and attitude(baseline, 1 month, 3 month)
  • Change in asthma knowledge(baseline, 1 month, 3 month)
  • Change in asthma medication confidence(Baseline, 1 month, 3 month)
  • Change in asthma control(baseline, 1 month, 3 month)
  • Change in asthma anxiety(baseline, 1 month, 3 month)
  • Change in asthma medication importance(baseline, 1 month, 3 month)

研究者

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

Karen MacDonell, PhD

Assistante Professor

Wayne State University

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