Diagnostic Labeling: Effect on White Coat Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in blood pressure
研究概览
简要总结
The purpose of this study is to find out whether labeling adults with prehypertension has negative effects on clinic blood pressure and quality of life 3 months after diagnosis.
详细描述
Previous research has shown that a diagnosis of hypertension is associated with subsequent increases in resting blood pressure, and there is preliminary evidence of a cross-sectional association between hypertension labeling and the white coat effect. The white coat effect may be particularly problematic in prehypertensives, because a small elevation in clinic blood pressure could result in crossing the diagnostic cutoff for hypertension, potentially leading to misdiagnosis and unnecessary treatment. This study will examine effects of prehypertension labeling on clinic and ambulatory blood pressure, and will examine potential psychological mediators of these associations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- 是
入选标准
- •at least 18 years
- •average screening systolic blood pressure of 120-139 mmHg OR diastolic blood pressure of 80-89 mmHg
- •average screening systolic blood pressure below 140 mmHg AND diastolic blood pressure below 90 mmHg
- •able to read and write in English
排除标准
- •past diagnosis of hypertension, prehypertension, or high blood pressure
- •current or past use of antihypertensive medications
- •renal disease
- •cardiovascular disease
- •current participation in another hypertension-related clinical trial
研究组 & 干预措施
Labeled
干预措施: Labeled prehypertension (Behavioral)
Unlabeled
干预措施: Unlabeled prehypertension (Behavioral)
结局指标
主要结局
Change in blood pressure
时间窗: Baseline, 3 months
次要结局
- Change in health-related quality of life (SF-12 questionnaires)(Baseline, 3 months)