Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
1614 participants
INTERVENTIONAL
2025-02-27
2026-04-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Neurological Trajectory and Clinical Outcomes in Brain Acute Ischemic Stroke
NCT06170086
Chinese Acute Ischemic Stroke Treatment Outcome Registry
NCT02470624
Ventilation Modalities and Acute Ischemic Stroke
NCT05323266
Clinical Outcomes Following Primary Intracerebral Hemorrhage
NCT06548737
The Prediction of Hemorrhage Transformation by Cerebral Autoregulation in AIS Patient After Endovascular Thrombectomy
NCT06361017
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervetnion group (Home-Based care group)
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.
Home-based therapy
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.
Control group (standard care group)
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.
Standard Care (in control arm)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Home-based therapy
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.
Standard Care (in control arm)
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking Union Medical College
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xuejun Yin
Prof
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-RC330-004
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CAMS&PUMC-IEC-2025-008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.