Stroke Homecare and Recurrence Prevention
SHARP
2 other identifiers
interventional
1,614
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Feb 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2026
CompletedFebruary 5, 2025
January 1, 2025
1.2 years
January 21, 2025
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stroke Recurrence Rate within 12 Months of 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.
12 months after the start of the intervention
Secondary Outcomes (10)
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.
- +5 more secondary outcomes
Study Arms (2)
Intervetnion group (Home-Based care group)
EXPERIMENTALParticipants 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.
Control group (standard care group)
ACTIVE COMPARATORParticipants 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.
Interventions
The home-based intervention includes the following modules: 1. Management of Stroke Recurrence Risk Factors: Home-based monitoring and management of blood pressure, blood sugar, cholesterol, and medication adherence. 2. Functional Rehabilitation and Daily Living Skills: Home-based physical therapy, rehabilitation exercises, and recovery of daily living skills. 3. Psychological Health and Emotional Management: Home-based counseling and mental health support to address anxiety, depression, and stress. 4. Nutritional and Lifestyle Interventions: At-home guidance on healthy eating, lifestyle changes, and behavior modification to reduce stroke recurrence. 5. Risk and Complication Prevention: Home monitoring to prevent infections and other complications during recovery. 6. Caregiver Empowerment: Home-based caregiver training and support to improve caregiving skills and reduce caregiver stress.
The standard care intervention involves: Outpatient Visits: Routine follow-up visits to healthcare providers for stroke recovery monitoring, medication management, and adjustments. Inpatient Rehabilitation: Physical, occupational, and speech therapy delivered in hospital or rehabilitation centers, if required. Follow-up Appointments: Regular visits with stroke specialists and rehabilitation professionals for ongoing care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
January 21, 2025
First Posted
February 5, 2025
Study Start
February 27, 2025
Primary Completion
April 26, 2026
Study Completion
April 26, 2026
Last Updated
February 5, 2025
Record last verified: 2025-01