SaFaRI: Stroke Patients and Family Longitudinal Study in Rural China
Study Details
Study Description
Brief Summary
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, we 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.
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Blood pressure [change from baseline to 5-year of follow-up]
change in blood pressure
- Weight [change from baseline to 5-year of follow-up]
change in weight
- Height [change from baseline to 5-year of follow-up]
change in height
- Grip strength [at the fifth year after baseline]
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. We both measure 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.
- Neck circumference [at the fifth year after baseline]
participants' neck circumference
- Waist circumference [at the fifth year after baseline]
Participants' waist circumference
- Mobility [change from baseline to 5-year of follow-up]
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
Secondary Outcome Measures
- Cognitive function [at the fifth year after baseline]
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.
- Mental Health [change from baseline to 5-year of follow-up]
measured by using Patient Health Questions-9, an international standard instrument for screening, monitoring and measuring the severity of depression.
- Health related quality of life [change from baseline to 5-year of follow-up]
measured using EuroQol-5 Dimensions-5L (EQ5D)
- Medication adherence [change from baseline to 5-year of follow-up]
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
- Disease history [change from baseline to 5-year of follow-up]
collected through questionnaire and medical insurance records
- Lifestyle risk factors [change from baseline to 5-year of follow-up]
The factors include lack of exercise, alcohol, diet, obesity, and smoking, and will be collected through questionnaire.
- Basic activities of daily living [at the fifth year after baseline]
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.
- Instrumental activities of daily living [at the fifth year after baseline]
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.
- Disability [change from baseline to 5-year of follow-up]
measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)
Eligibility Criteria
Criteria
The eligible stroke patients should meet all the following criteria: those who
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aged more than 18 years old
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have a history of stroke diagnosed at county or higher-level hospitals, and are in stable condition;
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have at least a basic communication ability;
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give their informed consent and are willing to participate in the study.
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have participated in the primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA).
And excluding those who
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have serious mental diseases;
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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
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aged more than 18 years old
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is the spouse of the stroke patient who participates in SINEMA study;
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have at least a basic communication ability;
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give their informed consent and are willing to participate in the study.
And excluding those who
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have serious mental diseases;
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have other serious diseases, and have a remaining life expectancy of less than 6 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
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| 1 | Nanhe County | Xingtai | Hebei | China | 054400 |
Sponsors and Collaborators
- Duke Kunshan University
- Peking Union Medical College
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022DKU