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临床试验/NCT04685408
NCT04685408已完成不适用

A TargEted MAnageMent Intervention for Reducing Stroke Risk Factors in High Risk

Case Western Reserve University3 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2022年5月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
276
试验地点
3
主要终点
Change From Baseline Systolic Blood Pressure (BP) at 6 Months

研究概览

简要总结

The proposed 2-phase project will first refine the TargetEd MAnageMent (TEAM) intervention to ensure acceptability across a broad range of Ugandans at risk for stroke and then test the effects of TEAM in reducing stroke risk in a 3-site, prospective, 6-month randomized controlled trial (RCT).

详细描述

In Phase 1 of the project, stakeholder's advisory board (SAB) will be convened across 3 Ugandan sites. The SAB will be composed of up to 15 relevant stakeholders including 3 stroke survivors, 3 individuals with multiple stroke risk factors as defined above, 3 family members, 3 clinicians and 3 administrators who practice in the proposed study enrollment sites. The purpose of the SAB is to refine the TEAM intervention content to meet the needs of patients and professional healthcare stakeholders and suggest how TEAM might best be incorporated into clinical workflow, as well as give guidance and feedback on recruitment methods and advertisements.

Phase 2 of the project will be conducted across 3 Ugandan sites that will enroll a representative sample of Ugandans at risk for stroke (Kiruddu, Nsambya and Mbarara Hospitals and their associated outpatient clinics). In the RCT portion of the study, 246 participants will be randomized at baseline on a 1:1 basis to receive either TEAM (N= 123) or enhanced treatment as usual (ETAU) (N=123) and will be followed for a total of 6 months. Since stroke is a moderately long-term health outcome (years to decades) that typically occurs in the presence of one or more stroke risk factors, the project will focus on testing whether TEAM can modify well-established short-term biomarkers that predict stroke risk, specifically BP control, serum cholesterol and blood glucose control. Secondary outcomes of interest include additional stroke risk biomarkers, (HDL, LDL, triglycerides) diet, exercise, use of alcohol and tobacco, stroke knowledge/attitudes, stress, and treatment adherence with risk-reducing medications. We will also explore associations of age, gender, urban vs. rural residential status and stroke history (prior vs. no previous stroke) on TEAM outcomes. To help inform future scale-up should RCT findings be positive, we will assess barriers and facilitators to TEAM implementation using both qualitative and quantitative methods.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age range: ≥ 18 years
  • •At risk for stroke defined by the following:
  • •High systolic BP defined as ≥ 140 mmHg assessed on at least 2 occasions at least 3 days apart and either criterion b or c as noted below:
  • •At least 1 other modifiable stroke risk factor including: diabetes, hyperlipidemia, obesity, smoking, problem alcohol use or sedentary lifestyle. Problem alcohol use for screening purposes will be assessed with questions on frequency, type of alcohol and quantity consumed. Participants will be classified as engaging in potential problem alcohol use if they exceed the recommended level for safe alcohol intake i.e. more than 3 drinks on average every time they drink, or if they undertook binge drinking (i.e. more than 3 drinks on one occasion in the one month preceding the evaluation).
  • •History of stroke or transient ischemic attack within the past 5 years
  • •Able to participate in group sessions

排除标准

  • •Individuals who are unable or unwilling to provide written informed consent
  • •Individuals who have sickle-cell disease
  • •Females who are pregnant or lactating
  • •Individuals with dementia

研究组 & 干预措施

TargEted MAnageMent Intervention (TEAM)

Experimental

This arm will receive the experimental intervention, TargEted MAnageMent Intervention (TEAM)

干预措施: TEAM (Behavioral)

Enhanced treatment as usual (ETAU)

Active Comparator

This arm will receive the control intervention, Enhanced Treatment as Usual (ETAU).

干预措施: ETAU (Behavioral)

结局指标

主要结局

Change From Baseline Systolic Blood Pressure (BP) at 6 Months

时间窗: Baseline and 6 months

Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martha Sajatovic, MD

Professor

Case Western Reserve University

研究点 (3)

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