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临床试验/NCT01078532
NCT01078532已完成不适用

Self Management & Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (SMART PHR)

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 1,815 人开始时间: 2010年4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
1,815
试验地点
2
主要终点
improved targeted chronic disease outcomes

研究概览

简要总结

This project seeks to improve health care outcomes in complex patients with cardiovascular disease (CVD) or who are at high risk for developing CVD by promoting patient self-management. This will be accomplished in 4 diverse, large primary care practices through the following 3 aims: (1) develop a patient-specific, active component to an existing electronic PHR directed towards patients with complex illnesses that is designed to reduce the risk of cardiovascular disease, (2) conduct a randomized controlled trial of the effectiveness of passive and active PHRs for improving adherence and clinical outcomes of complex patients in an ambulatory environment, and (3) enumerate the barriers and facilitators to implementation and use of an PHR among providers and patients in an ambulatory setting. To accomplish the aim 1, a users group will be assembled to determine which potential features of an 'active PHR' would be most acceptable and useful to them. To accomplish the 2nd aim, 1,000 patients with complex chronic disease leading to increased cardiovascular risk (i.e., CVD or 2 of the 4 conditions of hypertension (HTN), diabetes mellitus (DM), or hyperlipidemia requiring at least one medication for control) will be randomized to a passive PHR (n=500), or an active PHR (n=500) at 4 sites where the PHR currently is installed and in use. Outcomes to be assessed include improvement in control of risk factors (e.g., blood pressure), frequency of compliance with testing guidelines (e.g., annual dilated retinal exams in DM), and clinical outcomes (e.g., myocardial infarction, hospitalizations). Aim 3 will be accomplished by surveying all participants using the PHR, along with nurses and physicians at the study sites, and by conducting focus groups of PHR participants, nurses, and physicians to determine the most useful features of the PHR and to barriers and facilitators of use.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >=18, if they have medically complex diseases that increase cardiovascular risk not yet a PHR user

排除标准

  • current PHR user life-expectancy of less than 6 months dementia or disability that prevents them from being able to utilize a PHR (such as blindness)

结局指标

主要结局

improved targeted chronic disease outcomes

时间窗: 1 year

blood pressure and low density lipoprotein level (LDL) in all patients, and A1C in patients who have diabetes. For patients on medications requiring monitoring of electrolytes and creatinine, we will look at changes in these parameters as well.

次要结局

  • change in value in these outcome measures (lipid levels, blood pressure, and A1c levels)(1 year)
  • rates of adherence to diagnostic and therapeutic recommendations(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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