Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- 12-month systolic blood pressure (SBP) change
研究概览
简要总结
This study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. Results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the United States.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Black or Hispanic
- •Age 18 years or older
- •English or Spanish speaking
- •Patients who have had an ischemic or hemorrhagic stroke
- •Modified Rankin scale score of ≤ 3
- •Average screening SBP ≥ 140 mm Hg from three BP readings taken at two separate visits with a validated automated device
- •Receiving care at the study site for at least 6 months and planning to continue receiving care at the site for the next two years.
排除标准
- •Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks including using the HBPTM or interacting with the NCM if he/she were to be randomized to the intervention group)
- •Participation in other clinical trials
- •Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record)
- •Patients with upper arm circumference ≥ 52 cm, the maximum limit of the extra-large BP cuff
- •Diagnosis of dialysis or end stage renal disease
- •Relocating out of area or extended travel during study period
- •Significant verbal speech impairment; unable to participate in intervention telephone sessions
- •Pregnant women
研究组 & 干预措施
Home BP Telemonitoring (HBPTM)
Participants will take home BP readings 3 days per week (morning and evening) for one week out of each month during the 12-month intervention.
干预措施: Home BP Telemonitoring (HBPTM) (Behavioral)
HBPTM + Nurse Case Management (NCM)
Participants will complete the same Home BP Telemonitoring protocol and will also complete 20 counseling phone calls with a nurse case manager during the 12-month intervention.
干预措施: Home BP Telemonitoring (HBPTM) (Behavioral)
HBPTM + Nurse Case Management (NCM)
Participants will complete the same Home BP Telemonitoring protocol and will also complete 20 counseling phone calls with a nurse case manager during the 12-month intervention.
干预措施: Nurse Case Management (NCM) (Behavioral)
结局指标
主要结局
12-month systolic blood pressure (SBP) change
时间窗: Baseline, 12 months
次要结局
- Cost-effectiveness for reducing SBP at 12 months(12 months)
- 24-month stroke recurrence(24 months)
- Cost-effectiveness for reducing stroke recurrence at 24 months(24 Months)