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临床试验/NCT00208104
NCT00208104终止不适用

Motivational Interviewing in Hypertensive African Americans

Columbia University2 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2002年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
167
试验地点
2
主要终点
Score on Morisky Medication Adherence Scale (MMAS-4)

研究概览

简要总结

The purpose of this project is to study ways to make it more likely that patients will take their blood pressure medicine as recommended by their doctors.

详细描述

The objective of this randomized control trial is to evaluate, among 190 African-American patients with poorly controlled hypertension followed in a community-based primary care practice, whether motivational interviewing is more effective than usual care (routine counseling) in achieving adherence to prescribed blood pressure medications at 12 months.

The project aims to: 1) determine whether patients who receive motivational interview counseling have greater reduction in both systolic and diastolic blood pressure than those in the control group at 12 months. Clinic blood pressure readings will be assessed at baseline and at every three months thereafter for one year and 2) assess the effect of self-efficacy and intrinsic motivation as potential mediators of motivational interview on adherence. Self-efficacy and intrinsic motivation will be assessed at baseline and every three months thereafter for one year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Care Provider)

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

  • The target population consisted of hypertensive African American patients who fulfilled the following eligibility criteria:
  • Self-identification as African American
  • Age 18 years or older
  • Diagnosis of hypertension utilizing ICD-9 codes 401-401.9 (the code for essential hypertension)
  • Taking at least one antihypertensive medication
  • Uncontrolled hypertension of a clinic blood pressure reading >140/90 mm Hg or 130/80 mm Hg (for those with kidney disease or diabetes) on two successive clinic visits prior to screening (defined per JNC VI criteria)
  • Fluent in English language

排除标准

  • Participants were excluded if they:
  • Had a diagnosis of cognitive impairment or serious medical condition as determined by their primary physician
  • Were unable to give informed consent
  • Refused to participate

结局指标

主要结局

Score on Morisky Medication Adherence Scale (MMAS-4)

时间窗: Up to one year from baseline

Adherence to antihypertensive medications will be assessed at baseline and every three months thereafter for one year using a validated 4-item scale developed by Morisky that specifically addresses medication-taking. The scale asks patients to respond "yes" or "no" to a set of 4 questions. A positive response to any question indicates a problem with adherence. Each positive answer is assigned a score of 1. The total possible score is 4 with higher score indicating poorer adherence.

次要结局

  • Blood pressure readings(Up to one year from baseline)
  • Score on efficacy scale(Up to one year from baseline)
  • Score on the Treatment Self-Regulation Questionnaire (TSRQ)(Up to one year from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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