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临床试验/NCT01024933
NCT01024933已完成不适用

Trial Using Motivational Interviewing Positive Affect and Self-Affirmation in Hypertension (TRIUMPH)

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2010年1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
238
试验地点
2
主要终点
The primary outcome is the blood pressure control.

研究概览

简要总结

The primary aim of this study is to evaluate whether an intervention that combines positive affect and self-affirmation with motivational interviewing (TRIUMPH) improves blood pressure control compared to an educational/behavioral contract intervention at 12 months. We hypothesize that a greater proportion of participants in the experimental arm of TRIUMPH will have adequate blood pressure control as defined by Seventh Joint National Committee on Detection, Evaluation and Treatment of Hypertension (JNC-7.)

详细描述

TRIUMPH is designed to build on the findings of our previous studies by combining positive affect and self affirmation with motivational interviewing in order to increase blood pressure control in community based practices that care for large numbers of hypertensive black patients. Patients in both the educational and behavioral contract control group and would receive a workbook, would make a behavioral contract, and a home blood pressure monitor. The positive affect/self-affirmation group would receive the same components as the control group. In addition the experimental group would receive a positive affect/self-affirmation induction and motivational interviewing.

Both the control group and the experimental group would be followed at 2 month intervals. The outcome blood pressure control in this group will be contrasted to the knowledge/behavioral contract group. We hypothesize that we can increase the percent of patients who have blood pressure control to 75%.

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
Single (Participant)

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

  • 18 years or older.
  • Must be receiving care within the Renaissance Health Network for at least one year.
  • Must have uncontrolled HTN defined as an average SBP>140 mmHg or DBP>90 mmHg on at least two previous visits in the past year and be taking at least one antihypertensive medication.
  • Must self-identify as Black, or African American.
  • Must have patient's physician to participate in the study.

排除标准

  • Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks).
  • Participation in other clinical trials.
  • Diagnosis of cognitive dysfunction or significant psychiatric comorbidity.

结局指标

主要结局

The primary outcome is the blood pressure control.

时间窗: 12 months

次要结局

  • The secondary outcome is within-patient change in Systolic Blood Pressure and Diastolic Blood Pressure.(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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