NCT05539443已完成不适用
Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Proportion of participants with 3-month SBP control
研究概览
简要总结
TEAMS-BP is a multicenter, participant-randomized controlled trial designed to compare the effectiveness of Intensive Tailored Telehealth Monitoring (ITTM) versus Intensive Clinic Management (ICM) on Blood Pressure (BP) control and patient activation for BP management following stroke
详细描述
The Feasibility phase will allow for a period in which to pilot implementation and evaluation of all systems for data acquisition, clinical management, and collection of 3-month outcomes. The study uses a parallel, 2-arm design with 1-to-1 randomization to treatment group. Randomization will be performed at the participant level, stratified by center, age (18-74, 75+), and race (Black/African American, non-Black/African American).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Diagnosis of ischemic stroke defined as acute brain, spinal cord, or retinal infarction based on objective evidence on imaging (such as a focal area of restricted diffusion on Magnetic Resonance Imaging [MRI]) in a defined vascular distribution or clinical evidence of focal ischemic injury based on symptoms persisting > 24 hours; or spontaneous hemorrhagic stroke defined as a focal collection of blood within the brain parenchyma that is non-traumatic and identified by brain computed tomography (CT) or brain MRI
- •Age ≥18 years
- •Discharged directly home from acute care or inpatient rehabilitation
- •SBP>130 at the post-acute clinic visit (within 21 days of discharge) & at Study Visit 1 (within 31 days of discharge)
- •Able to read and understand English or Spanish
- •Have access to a functioning smartphone or tablet with broadband access (required for the intervention)
- •Willing to install and use a study-compatible physical activity monitoring application on their smartphone or smartphone of a qualifying caregiver
- •Stated agreement to participate in either intervention to which they are assigned and attend all required study visits
- •Consent to receiving Short Message Service (SMS) required as part of the study interventions
- •Provision of a signed and dated informed consent form
排除标准
- •Subdural hematoma or subarachnoid hemorrhage
- •Current participation in another stroke clinical trial precluding dual enrollment
- •Presence of terminal illness, such as cancer, that limits life expectancy to <1 year
- •Diagnosis of end-stage renal disease defined as permanent kidney dysfunction requiring the use of hemodialysis or peritoneal dialysis
- •Pregnancy, lactation or planning to become pregnant
- •Late-stage Alzheimer's disease or related dementia
- •Transitioned to a facility such as skilled nursing or long-term care prior to enrollment
- •Any condition that in the opinion of the study investigator would preclude the participant from being able to safely participate in the trial
结局指标
主要结局
Proportion of participants with 3-month SBP control
时间窗: 3 months
次要结局
- Proportion of participants attending both visits among those who are randomized in the study(3 months)
- Systolic Blood Pressure Mean Value(3 months)
- Proportion of respondents with top score in overall experience on the Research Participant Perception Survey (RPPS)(3 months)
- Proportion of participants billed(3 months)
- Mean change in systolic blood pressure (SBP) at 3 months(Baseline, 3 month)
- Mean change in Partners in Health Scale (PIH) score at 3 months(Baseline, 3 month)
- Proportion of participants eligible among those screened(3 Month)
- Proportion of participants providing written informed consent among those eligible(Baseline)
研究者
研究点 (2)
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