Stroke Homecare and Recurrence Prevention (SHARP)

Peking Union Medical College

Status: Not yet enrolling

Conditions: Stroke

Treatments: Other: Standard Care (in control arm); Combination Product: Home-based therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06810024

2021-RC330-004 (Other Grant/Funding Number)

CAMS&PUMC-IEC-2025-008

Details and patient eligibility

About

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.

Enrollment: 1,614 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,614 participants in 2 patient groups

Intervetnion group (Home-Based care group)

Experimental group

Description:

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.

Treatment:

Combination Product: Home-based therapy

Control group (standard care group)

Active Comparator group

Description:

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.

Treatment:

Other: Standard Care (in control arm)