- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05792618
Stroke Patients and Family Longitudinal Study in Rural China (SaFaRI)
Stroke Patients and Family in Rural China: A Longitudinal Study in Hebei Province
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hebei
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Xingtai, Hebei, China, 054400
- Nanhe County
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: change from baseline to follow-up
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change in blood pressure
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change from baseline to follow-up
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Weight
Time Frame: change from baseline to follow-up
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change in weight
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change from baseline to follow-up
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Height
Time Frame: change from baseline to follow-up
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change in height
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change from baseline to follow-up
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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.
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at various follow-up stages
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Neck circumference
Time Frame: at various follow-up stages
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participants' neck circumference
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at various follow-up stages
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Waist circumference
Time Frame: at various follow-up stages
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Participants' waist circumference
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at various follow-up stages
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Mobility
Time Frame: at various follow-up stages
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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
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at various follow-up stages
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: at various follow-up stages
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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.
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at various follow-up stages
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Mental Health
Time Frame: change from baseline to follow-up
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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).
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change from baseline to follow-up
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Health related quality of life
Time Frame: change from baseline to follow-up
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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.
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change from baseline to follow-up
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Medication adherence
Time Frame: change from baseline to follow-up
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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
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change from baseline to follow-up
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Disease history
Time Frame: change from baseline to follow-up
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collected through questionnaire and medical insurance records
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change from baseline to follow-up
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Lifestyle risk factors
Time Frame: change from baseline to follow-up
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The factors include lack of exercise, alcohol, diet, obesity, and smoking, and will be collected through questionnaire.
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change from baseline to follow-up
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Basic activities of daily living
Time Frame: at various follow-up stages
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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.
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at various follow-up stages
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Instrumental activities of daily living
Time Frame: at various follow-up stages
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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.
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at various follow-up stages
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Disability
Time Frame: change from baseline to follow-up
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measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)
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change from baseline to follow-up
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Multimorbidity
Time Frame: at various follow-up stages
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Assessed by determining whether participants had additional diseases diagnosed in the hospital, excluding stroke
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at various follow-up stages
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Sensory and vitality functions
Time Frame: at various follow-up stages
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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.
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at various follow-up stages
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022DKU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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