NCT06783049

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,490

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Mar 2025Jan 2027

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

January 21, 2026

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

January 14, 2025

Last Update Submit

January 20, 2026

Conditions

Ischemic StrokeTransient Ischemic Attack (TIA)

Keywords

ischemic strokesecondary preventiondigital health

Outcome Measures

Primary Outcomes (2)

  • 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.

    From enrollment to 1 year follow-up

  • 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.

    From enrollment to 1 year follow-up

Secondary Outcomes (16)

  • Readmission to hospital within 1 year

    From enrollment to 1 year follow-up

  • Stroke-related readmission

    From enrollment to 1 year follow-up

  • Direct medical costs

    From enrollment to 1 year follow-up

  • Rate of good adherence to secondary prevention medicine

    From enrollment to 1 year follow-up

  • Adverse drug reaction

    From enrollment to 1 year follow-up

  • +11 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL
Behavioral: Cerebrovascular Disease Secondary Prevention Smart Management System

Interventions

Cerebrovascular Disease Secondary Prevention Smart Management SystemBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients already enrolled in other stroke-related healthcare quality improvement projects or clinical trials.
  • Patients or family members who refuse to sign the informed consent form.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang, China

ACTIVE NOT RECRUITING

Beijing Tiantan Hospital

Beijing, 100070, China

RECRUITING

Related Publications (12)

  • 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.

    PMID: 36221935RESULT

  • 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.

    PMID: 30615498RESULT

  • 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.

    PMID: 31167621RESULT

  • 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.

    PMID: 32160205RESULT

  • 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.

    PMID: 37800373RESULT

  • 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.

    PMID: 31708447RESULT

  • 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.

    PMID: 32475159RESULT

  • 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.

    PMID: 35703097RESULT

  • 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.

    PMID: 39043397RESULT

  • 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.

    PMID: 35533220RESULT

  • 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.

    PMID: 33323210RESULT

  • 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.

    PMID: 37459876RESULT

MeSH Terms

Conditions

Ischemic StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Central Study Contacts

Zhiyuan Feng, MD

CONTACT

86+15801290121fzyhhz1996@gmail.com

Chunjuan Wang, MD

CONTACT

86+18210100840wangchunjuan@ncrcnd.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 20, 2025

Study Start

March 3, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

January 21, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)