About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Parallel
Treatments tested in this trial
Home-based therapy
Combination productThe 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.
Standard Care (in control arm)
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Cardiovascular Events
This outcome measures the occurrence of cardiovascular events, including heart attacks, arrhythmias, and other major cardiovascular incidents, as confirmed by clinical doctors through electronic medical records, electrocardiograms, and imaging studies during the follow-up period.
All-Cause Mortality
This outcome tracks the occurrence of all-cause death during the study period, obtained through hospital records and death certificates.
Motor Function
This outcome assesses changes in motor function using standardized scale such as the Modified Rankin Scale (mRS)
Motor Function assessed by Barthel Index
This outcome assesses changes in motor function using standardized scale as the Barthel Index.
Locations
Sponsors and contacts
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