Stroke Patients and Family Longitudinal Study in Rural China

NCT05792618 | Completed

• 1 other identifier: 2022DKU
• Study Type: observational
• Target: 1,299
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (7)

• Blood pressure

  change in blood pressure

  change from baseline to follow-up

• Weight

  change in weight

  change from baseline to follow-up

• Height

  change in height

  change from baseline to follow-up

• 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

• Neck circumference

  participants' neck circumference

  at various follow-up stages

• Waist circumference

  Participants' waist circumference

  at various follow-up stages

• 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 Outcomes (11)

• Cognitive function

  at various follow-up stages

• Mental Health

  change from baseline to follow-up

• Health related quality of life

  change from baseline to follow-up

• Medication adherence

  change from baseline to follow-up

• Disease history

  change from baseline to follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke Kunshan University: lead
• Peking Union Medical College: collaborator

Study Sites (1)

Nanhe County

Xingtai, Hebei, 054400, China

Location

Related Publications (2)

• Yang B, Gong E, Chen X, Tan J, Peoples N, Li Y, Cai J, Li Y, Oldenburg B, Chen C, Dong D, Zhang X, Finkelstein E, Si L, Yan LL. Economic Evaluation of a Multicomponent mHealth Intervention for Stroke Management in Rural China: Cluster-Randomized Trial With 6-Year Follow-Up. JMIR Mhealth Uhealth. 2025 Sep 11;13:e75326. doi: 10.2196/75326.

  PMID: 40934495 DERIVED

• Tan J, Gong E, Gallis JA, Sun S, Chen X, Turner EL, Luo S, Duan J, Li Z, Wang Y, Yang B, Lu S, Tang S, Bettger JP, Oldenburg B, Miranda JJ, Karmacharya B, Kinra S, Shao R, Ebrahim S, Yan LL. Primary Care-Based Digital Health-Enabled Stroke Management Intervention: Long-Term Follow-Up of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2449561. doi: 10.1001/jamanetworkopen.2024.49561.

  PMID: 39671199 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: March 31, 2023
• Study Start: September 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)