Stroke Patients and Family Longitudinal Study in Rural China (SaFaRI)

Duke Kunshan University

Status: Completed

Conditions: Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT05792618

2022DKU

Details and patient eligibility

About

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.

Full 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.

TThe SaFaRI study conducted a new follow-up round for participants of the SINEMA trial in 2023. Initially including 1299 stroke patients at baseline, this follow-up also encompassed the patients' spouses. The study aimed to: 1) Evaluate the stroke patients' blood pressure reduction, adherence to secondary prevention medications, physical activity, recurrence of stroke, hospitalization rates, and mortality. 2) Assess the long-term effectiveness of the SINEMA intervention model after a 5-year follow-up by examining the knowledge, attitudes, and practices of village doctors. 3) Establish a dynamic and continuous cohort of stroke patients, representative of northern rural China, using data from the baseline and the 1-year follow-up visits.

In 2024, the cohort underwent another follow-up, which expanded to include the collection of additional diseases and their diagnosis dates, and also surveyed patients regarding their sensory and viatality function.

Enrollment: 1,299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.