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临床试验/NCT06810024
NCT06810024尚未招募不适用

Stroke Homecare and Recurrence Prevention

Peking Union Medical College0 个研究点目标入组 1,614 人开始时间: 2025年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,614
主要终点
Stroke Recurrence Rate within 12 Months of Intervention

研究概览

简要总结

Background and Significance:

Stroke is the leading cause of death in China, placing a heavy burden on patients, families, and society. Despite advancements in acute stroke treatment, the recurrence rate remains high, and secondary prevention faces significant challenges. Current standard care does not fully address the diverse needs of stroke patients. Home-based health care (HBHC) offers a promising new intervention, providing continuous medical support, personalized lifestyle changes, and improved medication adherence, potentially reducing the risk of stroke recurrence.

Study Objectives and Hypotheses:

The study seeks to assess the impact of HBHC on reducing stroke recurrence, improving quality of life, enhancing physical function, addressing psychological health issues, and increasing medication adherence. Additionally, the study will explore the cost-effectiveness of HBHC in reducing medical resource utilization and preventing cardiovascular events. It is hypothesized that HBHC will effectively reduce stroke recurrence and improve overall health outcomes.

Study Design This study is a multicenter, randomized controlled trial designed to assess the effectiveness and cost-effectiveness of a home-based health care (HBHC) model in preventing recurrent strokes. A total of 1,614 stroke patients will be recruited from multiple regions in China and randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive a comprehensive 12-month HBHC program that includes managing stroke recurrence risk factors, functional rehabilitation, daily living skills recovery, psychological health interventions, nutritional and lifestyle counseling, risk prevention, and caregiver empowerment. In contrast, the control group will receive standard post-stroke care and follow-up according to local guidelines. Both groups will undergo follow-up assessments at 6 and 12 months to evaluate stroke recurrence, quality of life, physical function, and psychological health. The study will span 2 years, with the primary outcome being the stroke recurrence rate within 12 months. Secondary outcomes include improvements in quality of life, physical function recovery, psychological health, medication adherence, cardiovascular events, and medical resource utilization. A process evaluation will also be conducted to assess the feasibility, adaptability, and implementation challenges of the HBHC model across different regions and patient populations.

Value and impact:

The findings will offer valuable insights into the feasibility and adaptability of HBHC across different regions and patient populations, contributing to the development of evidence-based strategies for improving long-term stroke management. Ultimately, this research will inform policy decisions, enhance clinical practice, and support the broader adoption of HBHC interventions to mitigate the burden of stroke and improve patient outcomes.

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
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18 years and older
  • •Diagnosed with ischemic or hemorrhagic stroke within the past month
  • •Clinically stable, having completed acute phase treatment, and about to be discharged in a normal condition
  • •Physically able to receive home-based health care services
  • •Residing in a community where home-based health care is available
  • •Able to provide informed consent or have a legally authorized representative provide consent

排除标准

  • •Receiving more than one month of post-discharge care at a stroke rehabilitation center or community rehabilitation center
  • •Severe comorbidities (e.g., cancer, respiratory failure, severe infections) with a life expectancy of less than 6 months
  • •Severe cognitive impairment or mental illness affecting adherence to the intervention
  • •Currently participating in another clinical trial

研究组 & 干预措施

Intervetnion group (Home-Based care group)

Experimental

Participants in this arm will receive a comprehensive home-based health care program designed to prevent stroke recurrence and enhance recovery. The intervention includes monitoring and management of stroke recurrence risk factors (e.g., blood pressure, blood sugar, cholesterol), functional rehabilitation, psychological health support, nutritional and lifestyle interventions, complication prevention, and caregiver empowerment. These interventions will be delivered over a 12-month period, and participants will be followed up at 6 and 12 months.

干预措施: Home-based therapy (Combination Product)

Control group (standard care group)

Active Comparator

Participants in this arm will receive standard post-stroke care according to local clinical guidelines. This care may include outpatient visits for monitoring and medication management, inpatient rehabilitation services (e.g., physical, occupational, speech therapy), follow-up appointments with healthcare providers, and community-based rehabilitation services. Participants will be followed up at 6 and 12 months to assess stroke recurrence and recovery outcomes.

干预措施: Standard Care (in control arm) (Other)

结局指标

主要结局

Stroke Recurrence Rate within 12 Months of Intervention

时间窗: 12 months after the start of the intervention

This outcome measures the occurrence of stroke recurrence in participants during the 12-month period following the start of the intervention. It aims to assess the effectiveness of the home-based health care intervention in reducing the risk of stroke recurrence compared to standard post-stroke care. Recurrence will be defined as a clinically confirmed stroke event (ischemic or hemorrhagic) occurring within 12 months of the intervention's initiation.

次要结局

  • Cardiovascular Events(12 months after the start of the intervention)
  • All-Cause Mortality(12 months after the start of the intervention)
  • Motor Function(6 months and 12 months after the start of the intervention)
  • Motor Function assessed by Barthel Index(6 months and 12 months after the start of the intervention)
  • Cognitive Function(6 months and 12 months after the start of the intervention.)
  • Depression(6 months and 12 months after the start of the intervention)
  • Anxiety(6 months and 12 months after the start of the intervention.)
  • Quality of Life using the EQ-5D scale(6 months and 12 months after the start of the intervention)
  • Healthcare Utilization (Hospitalizations and Emergency Visits)(12 months after the start of the intervention)
  • Knowledge, Beliefs, and Behaviors Related to Stroke Recurrence Prevention(12 months after the start of the intervention)

研究者

发起方
Peking Union Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xuejun Yin

Prof

Peking Union Medical College

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