Clinical trial NCT05792618: Stroke Patients and Family Longitudinal Study in Rural China
Official title: Stroke Patients and Family in Rural China: A Longitudinal Study in Hebei Province
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Duke Kunshan University
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College
First posted: 2023-03-31
Enrollment: 1299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be recruited from the SENEMA study sample and their spouses. The SENEMA study sample has the following characteristics: over 18 years old, have a history of stroke diagnosed at county hospital or higher-level facilities, are currently in a clinically stable condition and not receiving acute stroke treatment, will live in this village for at least 9 months during the next 12 months, have basic communication ability and give their informed consent. A total of 1299 individuals were included at baseline. After excluding those who died during the 1-year follow-up (n = 30), a total of 1269 people will be included in the 5-year follow-up.

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.

Eligibility 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.

Primary outcomes:
measure: Blood pressure
timeFrame: change from baseline to follow-up
measure: Weight
timeFrame: change from baseline to follow-up
measure: Height
timeFrame: change from baseline to follow-up
measure: Grip strength
timeFrame: at various follow-up stages
measure: Neck circumference
timeFrame: at various follow-up stages
measure: Waist circumference
timeFrame: at various follow-up stages
measure: Mobility
timeFrame: at various follow-up stages
Secondary outcomes:
measure: Cognitive function
timeFrame: at various follow-up stages
measure: Mental Health
timeFrame: change from baseline to follow-up
measure: Health related quality of life
timeFrame: change from baseline to follow-up
measure: Medication adherence
timeFrame: change from baseline to follow-up
measure: Disease history
timeFrame: change from baseline to follow-up
measure: Lifestyle risk factors
timeFrame: change from baseline to follow-up
measure: Basic activities of daily living
timeFrame: at various follow-up stages
measure: Instrumental activities of daily living
timeFrame: at various follow-up stages
measure: Disability
timeFrame: change from baseline to follow-up
measure: Multimorbidity
timeFrame: at various follow-up stages
measure: Sensory and vitality functions
timeFrame: at various follow-up stages
Other outcomes:
Locations:
city: Xingtai
country: China
facility: Nanhe County
state: Hebei
Study officials:
References: