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StrokeSINEMANCT03185858

SINEMA Model of Care to Improve the Health of Stroke Patients in Rural China

A study testing SINEMA intervention in people with 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

Despite the significant burden of stroke in rural China, secondary prevention of stroke is scarce. The aim of the study is to develop a system-integrated technology-enabled intervention (SINEMA) model for the secondary prevention of stroke in rural China and evaluate the effectiveness of the model compared with usual… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
SINEMA intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,299 participants
Where
1 siteChina
Study dates
23 Jun 2017to 31 Dec 2019
Phase
Interventional
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

Who may be able to join

  • are aged more than 18 years old;
  • have a history of stroke (including ischemic and hemorrhagic stroke) diagnosed at county hospital or higher-level facilities, and currently in a clinically stable condition and not receiving acute stroke treatment;
  • will live in this village for at least nine months during the next 12 months;
  • have a basic communication ability (i.e. can understand simple instructions);
  • give participant informed consent and are willing to participate in the study.

Who cannot join

  • are unable to get out of bed without maximum assistance;
  • have serious life-threatening disease such as cancers;
  • who have an expected life span 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: System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients in Rural China

Despite the significant burden of stroke in rural China, secondary prevention of stroke is scarce. The aim of the study is to develop a system-integrated technology-enabled intervention (SINEMA) model for the secondary prevention of stroke in rural China and evaluate the effectiveness of the model compared with usual care. The hypothesis is that trained village doctors, equipped with digital health technology, can provide essential evidence-based care to stroke survivors in rural China.

Read the detailed description

The SINEMA trial is a cluster-randomized controlled trial to evaluate the effectiveness of implementation of a system-integrated and technology-enabled model of care to improve the secondary prevention of stroke in Nanhe County, a rural area of Hebei province, China. Fifty villages from five townships are stratified randomized in a 1:1 ratio to either the intervention arm (implementing SINEMA model) or the control arm (usual care).

After a baseline survey, intervention will be implemented in 25 intervention villages, lasting for 12 months. Follow-up survey will be conducted in the same way in all villages at 12-month after the initial of the study. Process evaluation will be conducted every three month, and economic evaluation will also be conducted.

Conditions
Stroke
Being tested
SINEMA intervention
Keywords
secondary prevention, primary healthcare, village doctors, rural China, medication adherence, physical activity
Medical subject headings
Stroke, Medication Adherence, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SINEMA interventionBehavioural

    Provider-facing intervention includes the following components:

    (1) Systematic cascade training for village doctors; (2) monthly follow-up visits with the support of the SINEMA APP; (3) village doctor group activities; (4) performance feedback and incentives.

    Stroke survivor-facing intervention program includes the following components:

    (1) Briefing session; (2) monthly follow-up visits and follow-up handout; (3) daily voice message for health education.

Study groups in NCT03185858
Study groupRoleWhat they receive
SINEMA intervention groupExperimentalThe intervention arm will implement the SINEMA model for one year, which consists of a provider-facing intervention aiming to strengthen the capacity of village doctors in delivering stroke secondary prevention, and a stroke survivor-facing intervention aiming to promote medication adherence and physical activity.
Receives: Behavioral: SINEMA intervention
Control groupNo interventionVillages in the control arm continue their usual practice without the introduction of any of the SINEMA activities described above. People who have hypertension or who are at high-risk of hypertension may receive follow-up visits four times per year as part of the basic public health services required by the government.

What is being measured

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

  1. systolic blood pressure

    change in systolic blood pressure

    Measured: change from baseline to 12-month of follow-up

Secondary outcomes (5)

  1. 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: change from baseline to 12-month of follow-up

  2. 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 12-month of follow-up

  3. physical activity level

    measured using the short version of the International Physical Activity Questionnaire(IPAQ)

    Measured: change from baseline to 12-month of follow-up

  4. health related quality of life

    measured using EuroQol-5 Dimensions-5L (EQ5D)

    Measured: change from baseline to 12-month of follow-up

  5. diastolic blood pressure

    participants' diastolic blood pressure

    Measured: change from baseline to 12-month of follow-up

Timeline

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

  1. First posted14 Jun 2017
  2. Study start23 Jun 2017
  3. Primary completion31 Jul 2018
  4. Study completion31 Dec 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The SINEMA model, cognizant of health system's organization around primary, secondary and tertiary healthcare levels in China, adopts the principles of cascade training with feedback and task-sharing, and relies on existing human resources available at the community level. It also proposes the use of innovative mobile technology as tools (in the form of an Android-based SINEMA APP for village doctors and cellphone voice messages for participants). The overarching aim is to strengthen the capacity of village doctors on delivering services for the secondary prevention of stroke and promoting medication adherence and physical activity among stroke survivors.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03185858
Sponsor's protocol ID
2015MRC0012
Acronym
SINEMA
Status last verified
Sep 2020
First submitted
12 Jun 2017
Last updated
17 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigators will not share the individual participant data. But other researchers could contact PI if there is special inquiry.

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

  • Gong E, Sun L, Long Q, Xu H, Gu W, Bettger JP, Tan J, Ma J, Jafar TH, Oldenburg B, Yan LL. The Implementation of a Primary Care-Based Integrated Mobile Health Intervention for Stroke Management in Rural China: Mixed-Methods Process Evaluation. Front Public Health. 2021 Nov 17;9:774907. doi: 10.3389/fpubh.2021.774907. eCollection 2021.

    PubMed 34869187

  • Yan LL, Gong E, Gu W, Turner EL, Gallis JA, Zhou Y, Li Z, McCormack KE, Xu LQ, Bettger JP, Tang S, Wang Y, Oldenburg B. Effectiveness of a primary care-based integrated mobile health intervention for stroke management in rural China (SINEMA): A cluster-randomized controlled trial. PLoS Med. 2021 Apr 28;18(4):e1003582. doi: 10.1371/journal.pmed.1003582. eCollection 2021 Apr.

    PubMed 33909607

  • Gong E, Yan LL, McCormack K, Gallis JA, Bettger JP, Turner EL. System-integrated technology-enabled model of care (SINEMA) to improve the health of stroke patients in rural China: Statistical analysis plan for a cluster-randomized controlled trial. Int J Stroke. 2020 Feb;15(2):226-230. doi: 10.1177/1747493019869707. Epub 2019 Aug 28.

    PubMed 31462178

  • Wu N, Gong E, Wang B, Gu W, Ding N, Zhang Z, Chen M, Yan LL, Oldenburg B, Xu LQ. A Smart and Multifaceted Mobile Health System for Delivering Evidence-Based Secondary Prevention of Stroke in Rural China: Design, Development, and Feasibility Study. JMIR Mhealth Uhealth. 2019 Jul 19;7(7):e13503. doi: 10.2196/13503.

    PubMed 31325288

  • Gong E, Gu W, Sun C, Turner EL, Zhou Y, Li Z, Bettger JP, Oldenburg B, Amaya-Burns A, Wang Y, Xu LQ, Yao J, Dong D, Xu Z, Li C, Hou M, Yan LL. System-integrated technology-enabled model of care to improve the health of stroke patients in rural China: protocol for SINEMA-a cluster-randomized controlled trial. Am Heart J. 2019 Jan;207:27-39. doi: 10.1016/j.ahj.2018.08.015. Epub 2018 Sep 5.

    PubMed 30408621

Questions about this trial

What is this clinical trial studying?

A study testing SINEMA intervention in people with 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?

The sponsor lists 5 inclusion and 3 exclusion criteria. 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 17 Sep 2020. 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?

systolic blood pressure (time frame: change from baseline to 12-month of follow-up). 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 NCT03185858, which also lists 6 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 17 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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