StrokeSHARPNCT06810024
Stroke Homecare and Recurrence Prevention
A study testing Home-based therapy in people with Stroke, run by Peking Union Medical College.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Home-based therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,614 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2025to 26 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Stroke
- Being tested
- Home-based therapy, Standard Care (in control arm)
- Keywords
- stroke, home-based care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based therapyCombination product
The home-based intervention includes the following modules:
- Management of Stroke Recurrence Risk Factors: Home-based monitoring and management of blood pressure, blood sugar, cholesterol, and medication adherence.
- Functional Rehabilitation and Daily Living Skills: Home-based physical therapy, rehabilitation exercises, and recovery of daily living skills.
- Psychological Health and Emotional Management: Home-based counseling and mental health support to address anxiety, depression, and stress.
- Nutritional and Lifestyle Interventions: At-home guidance on healthy eating, lifestyle changes, and behavior modification to reduce stroke recurrence.
- Risk and Complication Prevention: Home monitoring to prevent infections and other complications during recovery.
- Caregiver Empowerment: Home-based caregiver training and support to improve caregiving skills and reduce caregiver stress.
Standard Care (in control arm)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervetnion group (Home-Based care group) | Experimental | 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. Receives: Combination Product: Home-based therapy |
| Control group (standard care group) | Active comparator | 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. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the start of the intervention
Secondary outcomes (10)
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.
Measured: 12 months after the start of the intervention
All-Cause Mortality
This outcome tracks the occurrence of all-cause death during the study period, obtained through hospital records and death certificates.
Measured: 12 months after the start of the intervention
Motor Function
This outcome assesses changes in motor function using standardized scale such as the Modified Rankin Scale (mRS)
Measured: 6 months and 12 months after the start of the intervention
Motor Function assessed by Barthel Index
This outcome assesses changes in motor function using standardized scale as the Barthel Index.
Measured: 6 months and 12 months after the start of the intervention
Cognitive Function
This outcome evaluates changes in cognitive function using assessments such as the Mini-Mental State Examination (MMSE).
Measured: 6 months and 12 months after the start of the intervention.
Depression
This outcome evaluates changes in depression levels using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a standardized tool for assessing the severity of depressive symptoms. The PHQ-9 score ranges from 0 to 27, with higher scores indicating worse depression severity.
Measured: 6 months and 12 months after the start of the intervention
Anxiety
This outcome assesses changes in anxiety levels using the Generalized Anxiety Disorder-7 (GAD-7) scale. The GAD-7 is a widely used tool for screening and measuring the severity of generalized anxiety disorder symptoms. The GAD-7 score ranges from 0 to 21, with higher scores indicating worse anxiety severity.
Measured: 6 months and 12 months after the start of the intervention.
Quality of Life using the EQ-5D scale
This outcome measures quality of life using the EQ-5D scale, which assesses various health dimensions such as mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: 6 months and 12 months after the start of the intervention
Healthcare Utilization (Hospitalizations and Emergency Visits)
This outcome evaluates the frequency of hospitalizations and emergency visits during the study period, as documented in hospital electronic medical records, emergency department records, and patient-reported data, confirmed through follow-up visits.
Measured: 12 months after the start of the intervention
Knowledge, Beliefs, and Behaviors Related to Stroke Recurrence Prevention
This outcome measures participants' knowledge, beliefs, and behaviors regarding stroke recurrence prevention, assessed through a structured survey questionnaire.
Measured: 12 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start27 Feb 2025 (estimated)
- Primary completion26 Apr 2026 (estimated)
- Study completion26 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuejun Yin, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810024
- Sponsor's protocol ID
- CAMS&PUMC-IEC-2025-008
- Other IDs
- 2021-RC330-004
- Acronym
- SHARP
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: In this study, individual participant data (IPD) might not be shared due to concerns related to privacy and confidentiality. Since the study involves sensitive health information, including stroke diagnoses, rehabilitation progress, and psychological assessments, sharing IPD could potentially violate participant privacy or breach confidentiality agreements.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Homecare and Recurrence Prevention
- ClinicalTrials.gov ID
- NCT06810024
- Acronym / sponsor ID
- SHARP / CAMS&PUMC-IEC-2025-008
- Conditions
- Stroke
- Keywords
- stroke, home-based care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,614 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 27 Feb 2025 (estimated)
- Primary completion
- 26 Apr 2026 (estimated)
- Study completion
- 26 Apr 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervetnion group (Home-Based care group) | Experimental | Combination Product: Home-based therapyParticipants 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 comparator | Other: Standard Care (in control arm)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based therapyThe 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. | Combination product | Intervetnion group (Home-Based care group) |
| 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. | Other | Control group (standard care group) |
Primary outcome
Stroke Recurrence Rate within 12 Months of Intervention
Time frame: 12 months after the start of the 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.
10 secondary outcomes
Cardiovascular Events
Time frame: 12 months after the start of the intervention
All-Cause Mortality
Time frame: 12 months after the start of the intervention
Motor Function
Time frame: 6 months and 12 months after the start of the intervention
Motor Function assessed by Barthel Index
Time frame: 6 months and 12 months after the start of the intervention
Cognitive Function
Time frame: 6 months and 12 months after the start of the intervention.
Depression
Time frame: 6 months and 12 months after the start of the intervention
Anxiety
Time frame: 6 months and 12 months after the start of the intervention.
Quality of Life using the EQ-5D scale
Time frame: 6 months and 12 months after the start of the intervention
Healthcare Utilization (Hospitalizations and Emergency Visits)
Time frame: 12 months after the start of the intervention
Knowledge, Beliefs, and Behaviors Related to Stroke Recurrence Prevention
Time frame: 12 months after the start of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Undecided. In this study, individual participant data (IPD) might not be shared due to concerns related to privacy and confidentiality. Since the study involves sensitive health information, including stroke diagnoses, rehabilitation progress, and psychological assessments, sharing IPD could potentially violate participant privacy or breach confidentiality agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based therapy in people with Stroke, run by Peking Union Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuejun Yin, PhD (18600988138, xyin@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Recurrence Rate within 12 Months of Intervention (time frame: 12 months after the start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.