RCT of LifeSkills Workshop on BP in Hypertensive Employees
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 主要终点
- change in mean office BP, covarying hostility and hostility x time (stratification variable)
研究概览
简要总结
A number of psychosocial risk factors have been strongly related to a range of health problems (chief among them CVD). Clinical research has shown that behavioral interventions have enormous promise to ameliorate the psychosocial distress, the health-damaging effects and the costs associated with these risk factors. However, few such programs have been implemented in a large-scale way. Corporations are increasingly interested in providing such services for their employees, but they have encountered difficulties in knowing which programs are most effective. Until these programs are developed as products that can be tested and shown to produce consistent benefits, dissemination of these beneficial programs will be hindered. Taken together, these findings make a strong case that the development of a standardized, protocol-driven behavioral intervention package that can be delivered in a wide range of corporate settings presents a remarkable commercial opportunity. The overall goal of this SBIR Fast-Track-funded project is to gain empirical evidence in a RCT that documents the effectiveness of the Williams LifeSkills Workshop (a protocol driven 6-session workshop) in reducing BP, psychosocial risk factors, and promoting positive health outcomes in a cost effective manner in a corporate setting. This empirical support, tested in a setting independent of the program developers and by an experienced research team, will then be used to help market the product in the corporate wellness marketplace. It is hypothesized that participants (employees in an urban medical center) in the LifeSkills intervention will experience greater reductions in blood pressure and improvements in measures of psychosocial well-being than those receiving usual medical care and given educational materials on reducing BP.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18-75
- •Employees of Columbia University Medical Center
- •BP >= 140/90 on 2 occasions (average of 3 readings each time)
排除标准
- •Pregnancy
- •End-stage Renal disease
- •BP > 165/110 (average over 3 readings)
结局指标
主要结局
change in mean office BP, covarying hostility and hostility x time (stratification variable)
时间窗: 2 months after end of treatment
The change in the mean office BP (evaluated automatically by BP-Tru device) from baseline to follow-up. Hostility, evaluated by Cook-Medley questionnaire (Barefoot scoring) was a stratification variable and thus was used as a covariate in the analysis
次要结局
- Changes in mean office BP, controlling for baseline medications and medication changes during trial(baseline to follow-up 2 months after end of intervention)
