Stroke Homecare and Recurrence Prevention (SHARP)

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 Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Combination product: Home-based therapy; Other: Standard Care (in control arm)

• Study Type: Interventional
• Enrollment (Estimated): 1614
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuejun Yin, PhD; Phone Number: 18600988138; Email: xyin@georgeinstitute.org.au
• Study Contact Backup: Name: Xuejun Yin, PhD; Phone Number: +86 18600988138; Email: yinxuejun@cams.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: Home-based therapy; 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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.	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).	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.	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.	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.	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.	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.	12 months after the start of the intervention

Collaborators and Investigators

• Sponsor: Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): February 27, 2025
• Primary Completion (Estimated): April 26, 2026
• Study Completion (Estimated): April 26, 2026

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: stroke; home-based care
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Stroke; Recurrence
• Other Study ID Numbers: CAMS&PUMC-IEC-2025-008; 2021-RC330-004 (Other Grant/Funding Number: Chinese Academy of Medical Sciences)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No