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临床试验/NCT01178060
NCT01178060已完成不适用

The Effectiveness of Personalized Stroke Risk Communication - A Pilot Randomized Controlled Trial

Durham VA Medical Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年9月1日最近更新:
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
90
试验地点
1
主要终点
Impact of personalized risk information

研究概览

简要总结

The goal of this research is to improve communication to Veterans. The investigators want to improve how doctors and nurses talk to patients about the risk of heart attack and stroke. The investigators will give everyone in the study information about the risk for heart attack or stroke. The investigators will also provide information on how to reduce this risk. This information will be given in one of two ways. The investigators want to see which way of giving information works better for veterans. The investigators also want to assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the impact of personalized risk communication on medication adherence and blood pressure. The investigators plan to enroll approximately 100 veterans for this study. All veterans will be from the Durham VA Primary Care Clinics. The investigators will ask everyone to be in the study for 3 months.

详细描述

Background:

In 2005, over 17,000 patients were treated for stroke within the VA with a cost of almost $315 million. Prevention of stroke through reduction of established risk factors is an essential part of the VA Stroke QUERI strategic plan for the VA. In spite of this, in the Veterans Affairs, only 13% of patients with known CVD achieve target BP and cholesterol control. Combining risk factors into a composite measure of risk offers a better global assessment of individual risk and is recommended by the American Heart Association and American Stroke Association for prioritizing interventions. This practice is rarely done in routine clinical practice and its use as a tool to motivate patient behavior has not been tested. Current evidence from VA patients suggests that patients with hypertension do not adequately translate their risk factors into an accurate estimation of stroke risk. Improving the accuracy of stroke risk perceptions may be particularly important in motivating risk reduction in patients.

Objectives:

The objectives of this study are to: 1.) Assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors. 2.) Evaluate the impact of personalized risk communication on medication adherence and blood pressure. 3.) Explore the feasibility and obtain sample size estimates for a larger, investigator initiative research (IIR) application testing this tool.

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •Enrolled in a Durham VA Primary Care Clinic for at least one year
  • •Age ≥ 55 years old
  • •Diagnosis ICD 401.0, 401.1, or 401.9 on outpatient electronic encounter forms in the prior year
  • •Received a prescription for hypertensive medication (ACE inhibitors, beta blockers, calcium channel blockers, diuretics, alpha1 blockers, and/or central alpha2 agonists) in the previous year
  • •Inadequate BP control based on an average of prior 12-month clinic BP measurements
  • •Have a baseline EKG within the last 5 years to evaluate the presence of left ventricular hypertrophy.

排除标准

  • •Hospitalized at the DVAMC for a myocardial infarction (MI), coronary artery revascularization, or diagnosis of metastatic cancer in the past 6 months
  • •Prior history of stroke
  • •Active diagnosis of psychosis or dementia documented in medical record
  • •Participating in another chronic disease self-management study
  • •Resident of a nursing home
  • •Does not have access to a telephone
  • •Refusal to provide informed consent

研究组 & 干预措施

Personalized Risk Information

Active Comparator

Patients received personalized stroke and heart attack risk assessment information.

干预措施: Personalized Heart Attack and Stroke Risk (Other)

Standard Education

Other

Patients received general risk information on heart attack and stroke.

干预措施: Standard Education (Other)

结局指标

主要结局

Impact of personalized risk information

时间窗: 3 month

Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.

Impact of personalized risk information

时间窗: baseline

Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.

次要结局

  • Evaluate impact on medication adherence(3-months)

研究者

申办方类型
Fed

研究点 (1)

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