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临床试验/NCT01304186
NCT01304186已完成不适用

An Automated, Tailored Information Application for Medication Health Literacy

Nova Southeastern University2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2010年6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
124
试验地点
2
主要终点
Medication adherence

研究概览

简要总结

The purpose of this study is to evaluate the acceptability and efficacy of a computer-based tailored information application designed to promote health literacy in persons treated for HIV infection. The study hypothesis is that the application will be acceptable and usable for persons treated for HIV infection, and will improve their levels of adherence to antiretroviral medication treatment.

详细描述

Health literacy is a critically important problem in improving the effectiveness of health care interventions. Patient behaviors essential to the successful treatment of HIV infection, such as high levels of medication adherence, may depend on patients understanding how to take medication, how to solve medication-related problems, and how to cope with medication side effects. An approach that has shown promise in promoting behavior change in HIV+ persons is the Information-Motivation-Behavior Skills (IMB) model. The intervention proposed in this application will implement a health literacy intervention based in part on insights about behavior change drawn from studies of this model. The purpose of the proposed research is to implement this intervention via a computer-based and automated tailored information application. Participants will first complete an automated computer-administered self interview (ACASI) that will assess medication knowledge, disease knowledge likely to be related to motivation, and problem solving skills. Results of this assessment will feed forward to an automated training application that provides individually-tailored training on these topics. This computer-based program will provide training, test understanding, and if necessary reteach and retest. It will also provide printed information for participants to take home to provide ongoing prompts. This study will comprise two phases. In the first, the program will be developed and tested with potential users to assess its usability and detect problems with the wording of materials. In the second phase, participants' health literacy and cognitive status will be evaluated, their adherence to a medication for HIV infection will be assessed using electronic monitoring, and the effects of the program on their adherence will be tested.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Aged 18 years or older
  • Currently treated with at least one medication for HIV infection
  • No change in target medication anticipated in the next two months
  • Able to participate in the study intervention in English

排除标准

  • Psychiatric or cognitive disorder of severity sufficient to make the potential participant unable to provide informed consent.
  • Not able to participate in the intervention using English.

结局指标

主要结局

Medication adherence

时间窗: Four weeks after intervention

Medication adherence is assessed using electronic monitoring of pill bottle openings via the Medication Event Monitoring System (MEMS) for the month before and the month after participants engage in the study intervention.

次要结局

  • Participant self-efficacy(Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention)
  • Mood(Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention)
  • Elements of the Information, Motivation, and Behavioral Skills Model(Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention)
  • Intervention acceptability and usability(Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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