Stroke Patients and Family in Rural China: A Longitudinal Study in Hebei Province
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,299
- Locations
- 1
- Primary Endpoint
- Mobility
Study Overview
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, 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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mobility
Time Frame: at various follow-up stages
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
Height
Time Frame: change from baseline to follow-up
change in height
Blood pressure
Time Frame: change from baseline to follow-up
change in blood pressure
Weight
Time Frame: change from baseline to follow-up
change in weight
Grip strength
Time Frame: at various follow-up stages
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.
Neck circumference
Time Frame: at various follow-up stages
participants' neck circumference
Waist circumference
Time Frame: at various follow-up stages
Participants' waist circumference
Secondary Outcomes
- Medication adherence(change from baseline to follow-up)
- Disability(change from baseline to follow-up)
- Sensory and vitality functions(at various follow-up stages)
- Cognitive function(at various follow-up stages)
- Disease history(change from baseline to follow-up)
- Basic activities of daily living(at various follow-up stages)
- Mental Health(change from baseline to follow-up)
- Instrumental activities of daily living(at various follow-up stages)
- Multimorbidity(at various follow-up stages)
- Health related quality of life(change from baseline to follow-up)
- Lifestyle risk factors(change from baseline to follow-up)