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StrokeSaFaRINCT05792618

Stroke Patients and Family Longitudinal Study in Rural China

An observational study of Stroke, run by Duke Kunshan University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
How many people
1,299 participants
Where
1 siteChina
Study dates
1 Sep 2022to 1 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanhe County

    Xingtai, Hebei, 054400

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Stroke
Medical subject headings
Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure

    change in blood pressure

    Measured: change from baseline to follow-up

  2. Weight

    change in weight

    Measured: change from baseline to follow-up

  3. Height

    change in height

    Measured: change from baseline to follow-up

  4. 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.

    Measured: at various follow-up stages

  5. Neck circumference

    participants' neck circumference

    Measured: at various follow-up stages

  6. Waist circumference

    Participants' waist circumference

    Measured: at various follow-up stages

  7. 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

    Measured: at various follow-up stages

Secondary outcomes (11)

  1. 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.

    Measured: at various follow-up stages

  2. 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).

    Measured: change from baseline to follow-up

  3. 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.

    Measured: change from baseline to follow-up

  4. 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

    Measured: change from baseline to follow-up

  5. Disease history

    collected through questionnaire and medical insurance records

    Measured: change from baseline to follow-up

  6. Lifestyle risk factors

    The factors include lack of exercise, alcohol, diet, obesity, and smoking, and will be collected through questionnaire.

    Measured: change from baseline to follow-up

  7. 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.

    Measured: at various follow-up stages

  8. 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.

    Measured: at various follow-up stages

  9. Disability

    measured using modified Rankin Scale (ranged 0 (no symptom) to 5 severe disability)

    Measured: change from baseline to follow-up

  10. Multimorbidity

    Assessed by determining whether participants had additional diseases diagnosed in the hospital, excluding stroke

    Measured: at various follow-up stages

  11. 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.

    Measured: at various follow-up stages

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2023
  2. Study start1 Sep 2022
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05792618
Sponsor's protocol ID
2022DKU
Acronym
SaFaRI
Status last verified
Jun 2024
First submitted
14 Nov 2022
Last updated
10 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40934495

  • 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.

    PubMed 39671199

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Duke Kunshan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure (time frame: change from baseline to follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05792618, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.

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