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临床试验/NCT00217334
NCT00217334已完成不适用

A Pragmatic Trial of Community Pharmacy Blood Pressure Clinics Linked With Family Medicine Practices to Improve the Monitoring and Management of High Blood Pressure Among Older Adults

Hamilton Health Sciences Corporation2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2002年11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
28
试验地点
2
主要终点
Difference in the change from baseline to 12 months exit

研究概览

简要总结

The Community Hypertension Assessment Trial (CHAT) is an investigation of the effect of community pharmacy based blood pressure (BP) monitoring sessions led by peer health educators, with feedback to family physicians, on the monitoring and management of blood pressure among older adults.

详细描述

Hypertension affects about 22% of Canadian adults and is a modifiable risk factor for cardiovascular disease. Most countries have increasing older adult populations and hypertension prevalence increases with age. However, the "rule of halves" still applies in many primary health care settings: half of the hypertensive patients are undiagnosed, half of the diagnosed patients are untreated, and half of the treated patients are uncontrolled.

Family physicians were randomly selected and approached to participate in CHAT. Paired cluster randomization was used, with practices as the unit of randomization. Data on blood pressure (BP) readings in the last year, diagnosis of hypertension, diagnosis of diabetes and/or target organ damage, and a current antihypertensive profile was extracted from the health records of 55 patients randomly selected in each practice. In practices allocated to the Intervention group, physicians sent a letter, with assistance from research staff, to invite all of their eligible patients 65 years and older to attend one or two BP sessions in nearby pharmacies. Inclusion criteria required that patients be regular patients in the practice, community-dwelling, and mobile/well enough to attend community sessions.

Public health authorities trained older adult volunteer peer health educators to assist patients at the sessions to accurately measure their BP using a validated automated device, and record BP readings and cardiovascular risk factors. The volunteers provided education about hypertension but did not perform a clinical function. A recommendation protocol ensured that the pharmacist and, if necessary, the physician was notified if patients had a very high BP or a very low BP accompanied by symptoms. A public health nurse was 'on-call' during the sessions in case clinical advice was needed. A volunteer coordinator facilitated the transfer of readings and patient-reported cardiovascular risk factors to physicians.

Accurate BP readings were obtained from the BPM-100 automated BP measuring device. Questionnaires were used to obtain self-report data on cardiovascular disease risk factors from patients, knowledge and attitudes about BP control from physicians, and attitudes and satisfaction with the program from peer health educators, pharmacists, and public health nurses.

The primary outcome measure followed an 'intention to treat' approach. The primary endpoint was the difference in the change from 12 months pre- to 12 months post-intervention in the proportion of eligible patients with a BP reading recorded in their health record with mean systolic <=140 mm Hg or mean diastolic <=90 mmHg; <=130 or <=80 if target organ damage or diabetes is present.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single

入排标准

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

入选标准

  • Non-academic (none of its members are full-time faculty members)
  • Full-time
  • Regular family practice in terms of size and case-mix
  • Able to provide an electronic roster that includes a mailing address of their patients 65 years and older

排除标准

  • work in walk-in clinics or emergency departments
  • about to retire
  • work part-time
  • fewer than 50 patients 65 years or older
  • specialized practice profile
  • Inclusion Criteria:
  • Community-dwelling
  • 65 years or older
  • Visited the practice at least once in the last year
  • Considered regular patients by the physician
  • Exclusion Criteria:
  • Terminally ill
  • Scheduled to have surgery during the program period
  • Not mobile to visit the pharmacy
  • Non-English-speaking and unable to attend with an English-speaking companion
  • Significant cognitive impairment

结局指标

主要结局

Difference in the change from baseline to 12 months exit

Assessment in the mean percent of patients with adequate

Assessment / blood pressure (BP) control in intervention compared to control practices

次要结局

  • Percent of patients with mean BP 140-159 / 90-99
  • Percent of patients with mean BP 160-179 / 100-110
  • Percent of patients with mean BP >180 / >110

研究者

申办方类型
Other

研究点 (2)

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