TREATMENT OF MILD HYPERTENSION--SIDE EFFECTS AND EFFICAC
TREATMENT OF MILD HYPERTENSION--SIDE EFFECTS AND EFFICAC
批准号:
3346297
负责人:
Thomas J. Coates
金额:
$37.51万
依托单位国家:
美国
项目类别:
财政年份:
1985
资助国家:
美国
项目状态:
已结题
起止时间:
1985-09-01 至 1988-08-31
关键词:
anxiety behavioral medicine beta antiadrenergic agent blood chemistry blood glucose body weight cardiovascular disorder prevention cholesterol drug adverse effect ethnic group human middle age (35-64) human subject human therapy evaluation hypertension memory perception placebos psychomotor reaction time triglycerides type A /type B personality urinalysis young adult human (21-34)
中文摘要
这是一项关于门诊轻症患者行为因素的研究,
高血压 研究人员将检查:(1)行为方面
影响(记忆缺陷和抑郁症状);和(2)
舒张压(DBP)控制的药物和非药物策略,
轻度高血压的治疗。
目标人群为轻度高血压患者(DBP - 90-104
18至59岁,在旧金山弗朗西斯科工作或居住。 一
在18个月的累积期内,将总共招募500名参与者
来自加州大学旧金山分校医疗中心的合作医疗机构,
由美国银行和海湾地区高血压理事会推荐
筛选程序。 将对潜在参与者进行评估,
两次临床访视和基线期间的合格性和排除标准
将在第三次门诊访视时进行心理测量。
将使用分层区组设计将受试者随机分配至以下组之一
四种治疗分配:美托洛尔、安慰剂、非药物+
安慰剂和非药物加美托洛尔。 非药理学
治疗是一种行为干预,改变饮食习惯和其他
生活方式因素,导致血液中的
压力 β-肾上腺素能受体阻滞剂的药物治疗
药物是治疗轻度高血压的标准方法。 至少15
将在一年随访期内安排访视,护士
从业人员将成为医疗保健提供者。 析因设计将
允许分别评估这两种干预措施的效果,
结合起来。
主要的结果测量将是记忆缺陷,抑郁
症状与DBP 心理变量将在3时进行评估,
12个月,每次访视时将获得DBP。
本研究将具有至少0.80的功效来检测显著的
记忆缺陷、抑郁症状和/或
治疗组之间的DBP控制。 这项研究还将审查,
虽然权力较小,但在特定情况下干预措施的有效性
轻度高血压患者的亚组。
如果非药物干预有效降低血液中
压力与较少的生物行为后遗症,它将适用于人
轻度高血压患者在该国的其他流动护理机构。
这项研究也将作为进一步调查的模式,
其他降压方案的非生物行为后遗症。
英文摘要
This is a study of behavioral factors in medical outpatients with mild
hypertension. The investigators will examine: (1) the behavioral side
effects (memory deficits and depressive symptoms); and (2) the efficacy in
diastolic blood pressure (DBP) control of drug and nondrug strategies in
the treatment of mild hypertension.
The target population will be persons with mild hypertension (DBP - 90-104
mm Hg) between 18 and 59 years old working or living in San Francisco. A
total of 500 participants will be recruited over an 18 month accrual period
from collaborating health facilities at the UCSF Medical Center and from
referrals made by the Bank of America and the Bay Area Hypertension Council
screening program. Potential participants will be evaluated for
eligibility and exclusion criteria during two clinic visits and baseline
psychological measures will be obtained at a third clinic visit.
Participants will be randomized using a stratified blocked design to one of
four treatment assignments: metoprolol, placebo, nonpharmacologial plus
placebo, and nonpharmacological plus metropolol. The nonpharmacological
treatment is a behavioral intervention to change dietary habits and other
lifestyle factors which contribute to the presence of elevated blood
pressure. The pharmacological treatment with a beta adrenergic blocking
drug is a standard approach to treating mild hypertension. At least 15
visits will be scheduled over the one year follow-up period and nurse
practitioners will be the health care providers. The factorial design will
permit the effects of these two interventions to be assessed separately and
in combination.
The primary outcome measurement will be memory deficits, depressive
symptoms and DBP. The psychological variables will be asssessed at 3 and
12 months and DBP will be obtained at each visit.
This study will have a power of at least .80 to detect a significant
difference (Alpha = 0.05) in memory deficits, depressive symptoms and/or
DBP control between the treatment groups. The study will also examine,
though with less power, the efficacy of the interventions in specified
subgroups of persons with mild hypertension.
If the nonpharmacologic intervention is effective in lowering blood
pressure with less biobehavioral sequelae, it will be applicable to persons
with mild hypertension in other ambulatory care settings of the country.
This study will also serve as a model for further investigation of
nonbiobehavioral sequelae of other antihypertensive regimes.
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海外基金