Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure (TEAMS-BP)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Attaining the Target Systolic Blood Pressure of <130 mmHg
研究概览
简要总结
TEAMS-BP is a Patient-Centered Outcomes Research Institute (PCORI)-funded trial under the Phased Large Awards for Comparative Effectiveness Research (PLACER) funding mechanism to evaluate two comprehensive and evidence-based strategies for managing blood pressure (BP) following stroke.
详细描述
Hypertension affects nearly half of the US population (46% of adults) and is the strongest risk factor for recurrent stroke. Prevalence in patients with ischemic or hemorrhagic stroke in the US varies by region (highest in the South) ranging from 70% to 82%, and is associated with greater risk of recurrent stroke, major cardiovascular events, and death. A vital question for stroke patients and caregivers is how to prevent a recurrent stroke and further adverse events. Multiple clinical trials have shown that lowering BP reduces the risk for cardiovascular disease and stroke. Few trials, however, included stroke patients with a focus on secondary prevention nor were representative of vulnerable populations. The former US Surgeon General recently published a Call to Action focused on BP with three goals: 1) make hypertension control a national priority; 2) ensure that communities support hypertension control; and 3) optimize patient care for hypertension control.
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
- •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
- •At least one of the following: documented history of hypertension; self-reported history of hypertension; use of
- •hypertension medications (either prescribed prior to stroke, administered during hospital stay, or prescribed at discharge)
- •Systolic Blood Pressure ≥ 130 mmHg
- •Able to read and understand English or Spanish,
- •Have access to a functioning smartphone or tablet with cellular connectivity
- •Willing to install and use a study-compatible physical activity monitoring application on their smartphone or tablet or smartphone or tablet 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
- •Consent to enrollment in Chronic Care Management 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
- •Mid upper arm circumference > 45 cm/17.7 inches or < 22 cm / 8.66 inches
- •Missing values for Systolic Blood Pressure or Patient Activation Measure (PAM) score at baseline
- •Any condition that in the opinion of the study investigator would preclude the participant from being able to safely participate in the trial
研究组 & 干预措施
Intensive Tailored Telehealth Management (ITTM)
ITTM is a novel adaptation of the Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink) model, based on the premise that patients have social and functional barriers to blood pressure management. In the ITTM arm, barriers to care are identified and addressed through Blood Pressure Care Plan messaging and referrals to needed resources. The ITTM intervention includes a tailored Blood Pressure Care Plan and health coaching contracted through INTERVENT. INTERVENT services may be reimbursed using Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) insurance billing codes. Blood pressure monitors and wearable physical activity trackers will be provided to participants as part of the study.
干预措施: Intensive Tailored Telehealth Management (Behavioral)
Intensive Clinic Management (ICM)
ICM is based on the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) model and includes blood pressure management at in-person follow-up visits occurring every 2 months when systolic blood pressures are at target (i.e., < 130 mmHg), and monthly when systolic blood pressure is ≥ 130 mmHg. Participants will also receive low-touch health promotion messaging via text messaging, with reminders focused on medication adherence, healthy diet, and physical activity and a tailored Blood Pressure Care Plan for managing stroke recovery. Participants will be encouraged to monitor their blood pressure at home and record values in logs. Blood pressure monitors will be provided as part of the study.
干预措施: Intensive Clinic Management (Behavioral)
结局指标
主要结局
Attaining the Target Systolic Blood Pressure of <130 mmHg
时间窗: Month 6
Systolic blood pressure will be calculated as the average of the second and third of 3 successive measures by the research coordinator according to standard protocols at 6 months (Study Visit 3).
次要结局
- Change in Systolic Blood Pressure (SBP) at from baseline to 6 months post-stroke(Baseline to Month 6)
- Number of major adverse cardiovascular events (MACE)(Month 12)
- Change in Patient Activation Measured with the Patient Activation Measure (PAM)(Month 6)