Stroke Patients and Family Longitudinal Study in Rural China

Study Overview
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Brief Summary
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SaFaRI is a large prospective cohort study in Hebei Province, rural Northern China including 1,299 stroke patients and their spouses. Follow-up visits take place from baseline until the fifth year after the baseline survey, investigating the lifestyle and health behavior, disease history, medication and adherence to medication, health status and self-reported health, cognitive function, and medication cost. As additional measures, the investigators will collect information on hospitalization, recurrence, and vital status from county medical insurance system and death record system. Patients will also have a physical examination comprising of assessment of blood pressure, weight, height, waist circumference, neck circumference, grip strength and the Timed Up and Go test.

Detailed Description
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SaFaRI is a prospective longitudinal follow-up study based on a cluster-randomized controlled trial (System-integrated technology-enabled model of care to improve the health of stroke patients in rural China, SINEMA study) to evaluate the effectiveness of the SINEMA model to improve the secondary prevention of stroke in Nanhe County, a rural area of Hebei Province, China. A total of 1299 stroke patients were included at baseline, of which 25 villages received the SINEMA intervention package. The SaFaRI study will conduct a new round of follow-up visit for participants of the SINEMA trial. In addition to the 1299 stroke patients included at baseline, this follow-up will also include the stroke patients' spouses. The specific objectives of this study are to 1) evaluate blood pressure reduction, adherence to secondary prevention medications, physical activity, stroke recurrence, hospitalization, and death of stroke patients, (2) examine the long-term effectiveness of the SINEMA intervention model post 5-year follow-up by evaluating the knowledge attitude and practice in delivering the secondary prevention of village doctors , and 3) establish a dynamic and continuous cohort of stroke patients with characteristics of northern rural China based on the data collection of the baseline survey and the 1-year follow-up visit.

Official Title
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Stroke Patients and Family in Rural China: A Longitudinal Study in Hebei Province

Conditions
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Stroke

Participation Criteria
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Eligibility Criteria
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The eligible stroke patients should meet all the following criteria: those who aged more than 18 years old have a history of stroke diagnosed at county or higher-level hospitals, and are in stable condition; have at least a basic communication ability; give their informed consent and are willing to participate in the study. have participated in the primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA). And excluding those who have serious mental diseases; have other serious diseases, and have a remaining life expectancy of less than 6 months. The eligible spouses should meet all the following criteria: those who aged more than 18 years old is the spouse of the stroke patient who participates in SINEMA study; have at least a basic communication ability; give their informed consent and are willing to participate in the study. And excluding those who have serious mental diseases; have other serious diseases, and have a remaining life expectancy of less than 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | change in blood pressure | change from baseline to 5-year of follow-up | 
| Weight | change in weight | change from baseline to 5-year of follow-up | 
| Height | change in height | change from baseline to 5-year of follow-up | 
| Grip strength | Grip strength (kilogram) will be estimated through the dynamometer (YuejianTM WL-1000, Nantong, China). Trained examiners will instruct people to hold the dynamometer and squeeze the handle for a few seconds. This study both measures right and left-hand grip strength twice in each hand. The grip strength will be recorded separately. If the average grip strength of both right and left hand of is all less than the criteria (man < 30 kg, woman < 20 kg), it is defined as weak grip strength. | at the fifth year after baseline | 
| Neck circumference | participants' neck circumference | at the fifth year after baseline | 
| Waist circumference | Participants' waist circumference | at the fifth year after baseline | 
| Mobility | measured by timed-up-and-go test, a simple and quick functional mobility test that requires the participants to stand up, walk 3 meters, turn, walk back, and sit down | change from baseline to 5-year of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | measured by a brief version of the Community Screening Instrument for Dementia (CSI-D). The brief CSI-D was developed by Martin Prince, which consist of 7 cognitive items (Prince, M., Acosta, D., Ferri, C. P., Guerra, M., Huang, Y., Jacob, K. S., ... & 10/66 Dementia Group. (2011). A brief dementia screener suitable for use by non-specialists in resource poor settings-the cross-cultural derivation and validation of the brief Community Screening Instrument for Dementia. International journal of geriatric psychiatry, 26(9), 899-907.). The score of the brief CSI-D ranges from 0 to 9, with 0-4 represent Probable dementia, 5-6 represent Possible dementia, and 7-9 represent Normal. | at the fifth year after baseline | 
| Mental Health | measured by using Patient Health Questions-9, an international standard instrument for screening, monitoring and measuring the severity of depression. The total scores range from 0 (no depression) to 27 (severe depression). | change from baseline to 5-year of follow-up | 
| Health related quality of life | measured using EuroQol-5 Dimensions-5L (EQ5D-5L). EQ-5D-5L descriptive system comprises the following five dimensions, each describing a different aspect of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each domain, the total scores range from 0 (indicating no problem) to 5 (indicating unable to/extreme problems). In addition, the participants were required to assess how their health is today by write a number from 0 to 100 on the numbered scale. 100 means the best health the participant can image, 0 means the worst health the participant can image. | change from baseline to 5-year of follow-up | 
| Medication adherence | measured using 4 item Morisky Green Levine Scale-4 (MMAS-4), which scores adherence from 0-4 and continuation of medication taking is measured by the total months of medication taking | change from baseline to 5-year of follow-up | 
| Disease history | collected through questionnaire and medical insurance records | change from baseline to 5-year of follow-up | 
| Lifestyle risk factors | The factors include lack of exercise, alcohol, diet, obesity, and smoking, and will be collected through questionnaire. | change from baseline to 5-year of follow-up | 
| Basic activities of daily living | measured by the basic activities of daily living (ADL). The basic ADL include the following categories: Ambulating, Feeding, Dressing, Personal hygiene, Continence, and Toileting. The ADL score ranges from 0 to 12. Limitation in ADL was defined as being scored greater than 0 on ADL scales, i.e., having some or severe limitation in at least one ADL item. Higher scores mean a worse functional independence. | at the fifth year after baseline | 
| Instrumental activities of daily living | measured by the Lawton Instrumental Activities of Daily Living (IADL) Scale to evaluate independent living skills. The scale measures eight domains of function, including food preparation, housekeeping, laundering. The IADL score ranges from 0 to 14. Limitation in IADL was defined as being scored greater than 0 on IADL scales, i.e., having some or severe limitation in at least one IADL item. Higher scores mean a worse functional independence. | at the fifth year after baseline | 
| Disability | measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability) | change from baseline to 5-year of follow-up |