Clinical trial NCT06810024: Stroke Homecare and Recurrence Prevention
Official title: Stroke Homecare and Recurrence Prevention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
home-based care
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 1614
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Stroke Recurrence Rate within 12 Months of Intervention
timeFrame: 12 months after the start of the intervention
Secondary outcomes:
measure: Cardiovascular Events
timeFrame: 12 months after the start of the intervention
measure: All-Cause Mortality
timeFrame: 12 months after the start of the intervention
measure: Motor Function
timeFrame: 6 months and 12 months after the start of the intervention
measure: Motor Function assessed by Barthel Index
timeFrame: 6 months and 12 months after the start of the intervention
measure: Cognitive Function
timeFrame: 6 months and 12 months after the start of the intervention.
measure: Depression
timeFrame: 6 months and 12 months after the start of the intervention
measure: Anxiety
timeFrame: 6 months and 12 months after the start of the intervention.
measure: Quality of Life using the EQ-5D scale
timeFrame: 6 months and 12 months after the start of the intervention
measure: Healthcare Utilization (Hospitalizations and Emergency Visits)
timeFrame: 12 months after the start of the intervention
measure: Knowledge, Beliefs, and Behaviors Related to Stroke Recurrence Prevention
timeFrame: 12 months after the start of the intervention
Other outcomes:
Locations:
Study officials:
References: