Stroke Patients and Family Longitudinal Study in Rural China

Stroke Clinical Trial

— SaFaRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05792618
• Other study ID #: 2022DKU
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2024
• Source: Duke Kunshan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1299
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
China	Nanhe County	Xingtai	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Duke Kunshan University	Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	change in blood pressure	change from baseline to follow-up
Primary	Weight	change in weight	change from baseline to follow-up
Primary	Height	change in height	change from baseline to follow-up
Primary	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 various follow-up stages
Primary	Neck circumference	participants' neck circumference	at various follow-up stages
Primary	Waist circumference	Participants' waist circumference	at various follow-up stages
Primary	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	at various follow-up stages
Secondary	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 various follow-up stages
Secondary	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 follow-up
Secondary	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 follow-up
Secondary	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 follow-up
Secondary	Disease history	collected through questionnaire and medical insurance records	change from baseline to follow-up
Secondary	Lifestyle risk factors	The factors include lack of exercise, alcohol, diet, obesity, and smoking, and will be collected through questionnaire.	change from baseline to follow-up
Secondary	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 various follow-up stages
Secondary	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 various follow-up stages
Secondary	Disability	measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)	change from baseline to follow-up
Secondary	Multimorbidity	Assessed by determining whether participants had additional diseases diagnosed in the hospital, excluding stroke	at various follow-up stages
Secondary	Sensory and vitality functions	Assessed by querying your usual use of corrective lenses for vision, your ability to recognize distant and close objects, your use of hearing aids, and the quality of your hearing in different conditions.	at various follow-up stages