ClinicalTrials.gg
RecruitingNCT06783049SPIRITUpdated Jan 21, 2026

Secondary Prevention of Ischemic Stroke and Transient Ischemic Attack With an Intelligent Management System

An interventional study of Cerebrovascular Disease Secondary Prevention Smart Management System in Ischemic Stroke and Transient Ischemic Attack (TIA), sponsored by Beijing Tiantan Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
4,490
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to develop a digital health-based intelligent management system for the secondary prevention of ischemic stroke and to evaluate its effectiveness through a multicenter randomized controlled trial, assessing its health economic value.

Participants will receive usual care after discharge (control group) or be managed with a WeChat-based intelligent management system after discharge (intervention group).

At one year, all patients will undergo face-to-face follow-up to assess clinical events, medication adherence, and the achievement of target risk factor levels.

Read the detailed description

Before discharge, patients receive standard education on the secondary prevention of ischemic stroke from their physician, covering topics such as secondary prevention medications, risk factor management, lifestyle modifications, and rehabilitation. Additionally, the "Intelligent Management System," a WeChat-based applet, is activated for each patient. The system records basic patient information and integrates with mobile IoT devices, such as blood pressure monitors and glucose meters, allowing for self-monitoring of risk factors post-discharge. Based on international guidelines, high-level evidence, and the expertise of stroke specialists, a comprehensive clinical decision-making tree is established. This serves as the foundation for an AI feedback system that provides intelligent feedback on risk factor control and predicts recurrence risk. The patient interface includes educational content on ischemic stroke, risk factor management, lifestyle adjustments, and follow-up schedules post-discharge.

The system also features a physician interface, which enables attending doctors to offer online consultations, schedule face-to-face follow-up appointments, and manage patients long-term. Each patient is assigned to an "Online Stroke Care Team," which includes a "Health Management Officer" responsible for facilitating communication between the patient and the physician and providing basic health guidance. Additionally, an "Online Doctor" is available to answer stroke-related medical questions.

The Health Management Officer monitors patients' health data and arranges online or in-person consultations for those with poor adherence or suboptimal target achievement. Patient management is guided by the theory of health empowerment, creating an integrated online and offline ischemic stroke management intervention model.

02

Conditions studied

  • Ischemic Stroke
  • Transient Ischemic Attack (TIA)

Keywords

  • ischemic stroke
  • secondary prevention
  • digital health
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 4,490 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years.
  2. Patients diagnosed with acute ischemic stroke or .
  3. Time from onset to enrollment ≤ 14 days.
  4. Presence of at least one modifiable risk factor (hypertension, diabetes).
  5. Ability to independently use a smartphone to complete system tasks upon discharge, or with the assistance of family members.
  6. Signed by the patient or their family members.

Exclusion criteria

Exclusion Criteria:

  1. Patients already enrolled in other stroke-related healthcare quality improvement projects or clinical trials.
  2. Patients or family members who refuse to sign the form.
  3. Pregnant or breastfeeding women.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
4,490 participants (estimated)

Study arms

  • No intervention
    Control group

    Patients in the control group received secondary stroke prevention discharge recommendations from their attending physicians, based on standard medical practice. No additional interventions for secondary prevention were applied throughout the study.

  • Experimental
    Intervention group

    Behavioral: Cerebrovascular Disease Secondary Prevention Smart Management System

Interventions

  • BehavioralCerebrovascular Disease Secondary Prevention Smart Management System

    The continuous post-discharge intervention for patients was conducted using the Cerebrovascular Disease Secondary Prevention Smart Management System. This system, integrated with a WeChat-based applet, records patients' basic information and connects with mobile IoT devices such as blood pressure monitors and glucose meters. This allows patients to self-monitor their risk factors post-discharge. Based on international guidelines, high-level evidence, and the clinical expertise of cerebrovascular specialists, a comprehensive clinical decision-making tree was developed. This serves as the foundation for an AI feedback system that provides intelligent feedback on risk factor control and predicts the risk of recurrence.

06

What researchers measure

Primary outcomes

  1. Vascular events and all-causes death

    Vascular and all-cause mortality events were collected for one year post-enrollment through face-to-face follow-ups and patient self-reports. Vascular events included stroke recurrence, transient ischemic attacks, myocardial infarction, vascular interventions or surgeries, and systemic embolism. If a patient experienced both a vascular event and death, only one event was recorded. In cases of multiple vascular events, only the first event was documented.

    Time frame: From enrollment to 1 year follow-up

  2. Risk factor control rate

    Risk factor control was defined as achieving glycated hemoglobin (HbA1c) ≤7% or blood pressure below the target set at discharge. If a patient had both hypertension and diabetes at enrollment, meeting the criteria for both conditions was considered two achieved targets. If the patient had only hypertension or diabetes at enrollment, meeting the target for the respective condition was considered one achieved target.

    Time frame: From enrollment to 1 year follow-up

Secondary outcomes

  1. Readmission to hospital within 1 year

    Time frame: From enrollment to 1 year follow-up

  2. Stroke-related readmission

    Time frame: From enrollment to 1 year follow-up

  3. Direct medical costs

    Time frame: From enrollment to 1 year follow-up

  4. Rate of good adherence to secondary prevention medicine

    Time frame: From enrollment to 1 year follow-up

  5. Adverse drug reaction

    Time frame: From enrollment to 1 year follow-up

  6. Body mass index

    Time frame: From enrollment to 1 year follow-up

  7. Waist circumstance

    Time frame: From enrollment to 1 year follow-up

  8. Frequency of blood pressure monitoring

    calculated as time/week

    Time frame: From enrollment to 1 year follow-up

  9. Frequency of blood glucose monitoring

    calculated as time/week

    Time frame: From enrollment to 1 year follow-up

  10. Blood lipid levels

    Included total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceridee

    Time frame: From enrollment to 1 year follow-up

  11. Rehabilitation

    Time frame: From enrollment to 1 year follow-up

  12. Smoking

    Time frame: From enrollment to 1 year follow-up

  13. Alcohol

    Time frame: From enrollment to 1 year follow-up

  14. Regular exercise

    Time frame: From enrollment to 1 year follow-up

  15. Overall physical activity level

    Assessed by IPAQ-S, calculated as MET-min/week

    Time frame: From enrollment to 1 year follow-up

  16. Fatigue

    Assessed by Fatigue Severity Scale (FSS). Fatigue was defined as total FSS score ≥36

    Time frame: From enrollment to 1 year follow-up

07

Study locations

1 of 3 sites recruiting
08

References and documents

Publications

  • Bonura A, Motolese F, Capone F, Iaccarino G, Alessiani M, Ferrante M, Calandrelli R, Di Lazzaro V, Pilato F. Smartphone App in Stroke Management: A Narrative Updated Review. J Stroke. 2022 Sep;24(3):323-334. doi: 10.5853/jos.2022.01410. Epub 2022 Sep 30. PubMed 36221935 ↗
  • Schwamm LH. Digital Health Strategies to Improve Care and Continuity Within Stroke Systems of Care in the United States. Circulation. 2019 Jan 8;139(2):149-151. doi: 10.1161/CIRCULATIONAHA.117.029234. No abstract available. PubMed 30615498 ↗
  • Requena M, Montiel E, Baladas M, Muchada M, Boned S, Lopez R, Rodriguez-Villatoro N, Juega J, Garcia-Tornel A, Rodriguez-Luna D, Pagola J, Rubiera M, Molina CA, Ribo M. Farmalarm. Stroke. 2019 Jul;50(7):1819-1824. doi: 10.1161/STROKEAHA.118.024355. Epub 2019 Jun 6. PubMed 31167621 ↗
  • Kim BJ, Park JM, Park TH, Kim J, Lee J, Lee KJ, Lee J, Chae JE, Thabane L, Lee J, Bae HJ. Remote blood pressure monitoring and behavioral intensification for stroke: A randomized controlled feasibility trial. PLoS One. 2020 Mar 11;15(3):e0229483. doi: 10.1371/journal.pone.0229483. eCollection 2020. PubMed 32160205 ↗
  • Allan LP, Beilei L, Cameron J, Olaiya MT, Silvera-Tawil D, Adcock AK, English C, Gall SL, Cadilhac DA. A Scoping Review of mHealth Interventions for Secondary Prevention of Stroke: Implications for Policy and Practice. Stroke. 2023 Nov;54(11):2935-2945. doi: 10.1161/STROKEAHA.123.043794. Epub 2023 Oct 6. PubMed 37800373 ↗
  • Ahmadi M, Laumeier I, Ihl T, Steinicke M, Ferse C, Endres M, Grau A, Hastrup S, Poppert H, Palm F, Schoene M, Seifert CL, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Algra A, Amarenco P, Greving JP, Busse O, Kohler F, Marx P, Audebert HJ. A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial. Lancet Neurol. 2020 Jan;19(1):49-60. doi: 10.1016/S1474-4422(19)30369-2. Epub 2019 Nov 7. PubMed 31708447 ↗
  • Duncan PW, Bushnell CD, Jones SB, Psioda MA, Gesell SB, D'Agostino RB Jr, Sissine ME, Coleman SW, Johnson AM, Barton-Percival BF, Prvu-Bettger J, Calhoun AG, Cummings DM, Freburger JK, Halladay JR, Kucharska-Newton AM, Lundy-Lamm G, Lutz BJ, Mettam LH, Pastva AM, Xenakis JG, Ambrosius WT, Radman MD, Vetter B, Rosamond WD; COMPASS Site Investigators and Teams.. Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study. Circ Cardiovasc Qual Outcomes. 2020 Jun;13(6):e006285. doi: 10.1161/CIRCOUTCOMES.119.006285. Epub 2020 Jun 1. PubMed 32475159 ↗
  • Ihl T, Ahmadi M, Laumeier I, Steinicke M, Ferse C, Klyscz P, Endres M, Hastrup S, Poppert H, Palm F, Kandil FI, Weber JE, von Weitzel-Mudersbach P, Wimmer MLJ, Audebert HJ. Patient-Centered Outcomes in a Randomized Trial Investigating a Multimodal Prevention Program After Transient Ischemic Attack or Minor Stroke: The INSPiRE-TMS Trial. Stroke. 2022 Sep;53(9):2730-2738. doi: 10.1161/STROKEAHA.120.037503. Epub 2022 Jun 15. PubMed 35703097 ↗
  • Song J, Wang X, Wang B, Ge Y, Bi L, Jing F, Jin H, Li T, Gu B, Wang L, Hao J, Zhao Y, Liu J, Zhang H, Li X, Li J, Ma W, Wang J, Normand ST, Herrin J, Armitage J, Krumholz HM, Zheng X; LIGHT Collaborative Group. Learning implementation of a guideline based decision support system to improve hypertension treatment in primary care in China: pragmatic cluster randomised controlled trial. BMJ. 2024 Jul 23;386:e079143. doi: 10.1136/bmj-2023-079143. PubMed 39043397 ↗
  • Chow CK, Klimis H, Thiagalingam A, Redfern J, Hillis GS, Brieger D, Atherton J, Bhindi R, Chew DP, Collins N, Andrew Fitzpatrick M, Juergens C, Kangaharan N, Maiorana A, McGrady M, Poulter R, Shetty P, Waites J, Hamilton Craig C, Thompson P, Stepien S, Von Huben A, Rodgers A; TEXTMEDS Investigators*. Text Messages to Improve Medication Adherence and Secondary Prevention After Acute Coronary Syndrome: The TEXTMEDS Randomized Clinical Trial. Circulation. 2022 May 10;145(19):1443-1455. doi: 10.1161/CIRCULATIONAHA.121.056161. Epub 2022 May 9. PubMed 35533220 ↗
  • Dorje T, Zhao G, Tso K, Wang J, Chen Y, Tsokey L, Tan BK, Scheer A, Jacques A, Li Z, Wang R, Chow CK, Ge J, Maiorana A. Smartphone and social media-based cardiac rehabilitation and secondary prevention in China (SMART-CR/SP): a parallel-group, single-blind, randomised controlled trial. Lancet Digit Health. 2019 Nov;1(7):e363-e374. doi: 10.1016/S2589-7500(19)30151-7. Epub 2019 Oct 10. PubMed 33323210 ↗
  • Schwarzbach CJ, Eichner FA, Rucker V, Hofmann AL, Keller M, Audebert HJ, von Bandemer S, Engelter ST, Geis D, Groschel K, Haeusler KG, Hamann GF, Meisel A, Sander D, Schutzmeier M, Veltkamp R, Heuschmann PU, Grau AJ; SANO study group. The structured ambulatory post-stroke care program for outpatient aftercare in patients with ischaemic stroke in Germany (SANO): an open-label, cluster-randomised controlled trial. Lancet Neurol. 2023 Sep;22(9):787-799. doi: 10.1016/S1474-4422(23)00216-8. Epub 2023 Jul 14. PubMed 37459876 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06783049
Collaborators
Beijing Tsinghua Chang Gung Hospital, Xiangya Hospital of Zhongnan University, The affiliated Hospital of Shihezi University, The First Hospital of Jilin University, First People's Hospital of Foshan, The Second Affiliated Hospital of Fujian Medical University, BOE Technology Group Co., Ltd.
Responsible party
Zi-Xiao Li (Principal Investigator, Beijing Tiantan Hospital) — Principal investigator
First posted
Jan 20, 2025
Start date
Mar 3, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Jan 21, 2026

Study contacts

Zhiyuan Feng, MD
Contact
fzyhhz1996@gmail.com
86+15801290121
Chunjuan Wang, MD
Contact
wangchunjuan@ncrcnd.org.cn
86+18210100840

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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