跳至主要内容
临床试验/NCT01038076
NCT01038076已完成不适用

Implementing Computerized Clinical Assessment of HIV Patient Adherence

Boston University6 个研究点 分布在 1 个国家目标入组 371 人开始时间: 2009年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
371
试验地点
6
主要终点
Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.

研究概览

简要总结

This study will examine whether a computerized, self-administered assessment of patient medication adherence and health behaviors, plus support for adherence, improves the ability of clinicians to identify adherence problems and leads to better adherence.

详细描述

Antiretroviral medications are highly effective in controlling HIV, if patients adhere to the regimen. However, HIV medication adherence problems are very common, and evidence is clear that providers have great difficulty 'diagnosing' poor adherence accurately. If healthcare providers can identify patients with adherence problems, they can intervene to help patients overcome these problems and take their medications as prescribed, which can improve symptoms and quality and length of life. Both clinicians and HIV positive patients will be recruited to this study. Before each clinic visit, patients randomized to the intervention will be asked to answer questions about their medications, medication-taking behavior, and risk-factors for non-adherence on MedCHEC, a tablet touch-screen computer that generates provider and patient reports. We will give these reports to the provider and patient to assist with the clinical visit. Based on the MedCHEC-generated report, the patient may be referred to an Adherence Care Manager (ACM). The ACM will assist the patient in overcoming adherence barriers by telephone and in-clinic counseling. The study will evaluate the effects of this system on adherence and clinical care using both quantitative methods (randomized controlled trials of effects on adherence and providers' adherence estimates), and qualitative methods.

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

入选标准

  • Over 18 years of age
  • Confirmed HIV-positive
  • On or newly starting antiretroviral medication for HIV
  • Under treatment at one of the study sites
  • Available by telephone

排除标准

  • Clinically diagnosed by provider with significant cognitive impairment, or Mini-Mental Status Exam score less than or equal to 22
  • Inability to read English
  • Inability or refusal to use MedCHEC touch-screen computer
  • Inability or refusal to use any form of electronic drug monitoring device (MEMS)
  • Never available by telephone

研究组 & 干预措施

MedCHEC Tablet Computer & Adherence Care

Experimental

Patients assigned to the intervention answer questions about their medication, medication-taking behavior and risks for non-adherence on the MedCHEC tablet touch-screen computer, which generates provider and patient reports. Patients may be referred to an Adherence Care Manager on the basis of the reports. In addition, patients will receive standard information about adherence.

干预措施: MedCHEC Tablet Computer & Adherence Care (Behavioral)

Adherence Information Only

No Intervention

Patients assigned to the active comparator arm will receive standard information about adherence.

结局指标

主要结局

Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.

时间窗: 1 year

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

Allen L. Gifford

Professor of Public Health and Medicine

Boston University

研究点 (6)

Loading locations...

相似试验