NCT00662753已完成1 期
A Structured Program for Hypertension Control in Community Clinics: A Randomized Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 4
- 主要终点
- Blood Pressure
研究概览
简要总结
The purpose of this study is to determine if the use of home blood pressure monitors plus nurse telephone monitoring is more effective than the use of blood pressure monitors alone in improving control of high blood pressure in an urban medical clinic.
详细描述
Participants will all have home blood pressure monitors, education session on controlling their blood pressure and will be randomized to recieve 6 months of intensive telephonic on a set monitoring schedule or no telephonic follow up. Phone calls will be weekly for 4 weeks, then every 2 weeks for 8 weeks then monthly for 3 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with essential hypertension
- •systolic blood pressure >140 mm Hg (130 if diabetic) OR diastolic blood pressure > 90 mm Hg (80 if diabetic)on at least 2 clinic visits prior to randomization
- •BP at time of screening is > than systolic 140 (130 if diabetic) or diastolic 90 (80 if diabetic)
- •patient is prescribed at least 1 antihypertensive medication
- •Patient is fluent in English
- •Patient is easily accessible by telephone
排除标准
- •persons with stage 4 or 5 chronic kidney disease or end stage renal disease on dialysis
- •Patients with a terminal illness
- •Patients with severe dementia or serious mental illness
- •Inability to preform self blood pressure monitoring
- •Patient lacks a functioning home phone or personal cellular phone
- •Pregnant or planning to get pregnant
- •Arm circumference exceeds the allowable limit on the largest home BP monitor cuff
结局指标
主要结局
Blood Pressure
时间窗: at 6 mo and 12 mo after randomization
次要结局
- Blood pressure measured at home(6 and 12 months post randomization)
- Patient satisfaction and Quality of Life(6 and 12 months post randomization)
- Primary care provider satisfaction with intervention(6 mo post randomization of a provider's first patient to enroll in the trial)
- Number and quality of adverse events(3, 6, and 12 months post randomization)
- cost analysis(12 months post randomization)
- Number and type of antihypertensives prescribed(12 months post randomization)
- Compliance with use of home blood pressure monitor(6 and 12 months post randomization)
- Number of primary care provider visits(12 months post randomization)
研究者
研究点 (4)
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