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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Cerebrovascular 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

Первичные конечные точки

• Vascular events and all-causes death [Срок оценки: From enrollment to 1 year follow-up]
• Risk factor control rate [Срок оценки: From enrollment to 1 year follow-up]

Вторичные конечные точки (12)

• Readmission to hospital within 1 year [Срок оценки: From enrollment to 1 year follow-up]
• Stroke-related readmission [Срок оценки: From enrollment to 1 year follow-up]
• Direct medical costs [Срок оценки: From enrollment to 1 year follow-up]
• Rate of good adherence to secondary prevention medicine [Срок оценки: From enrollment to 1 year follow-up]
• Adverse drug reaction [Срок оценки: From enrollment to 1 year follow-up]
• Body mass index [Срок оценки: From enrollment to 1 year follow-up]
• Waist circumstance [Срок оценки: From enrollment to 1 year follow-up]
• Frequency of blood pressure monitoring [Срок оценки: From enrollment to 1 year follow-up]
• Frequency of blood glucose monitoring [Срок оценки: From enrollment to 1 year follow-up]
• Blood lipid levels [Срок оценки: From enrollment to 1 year follow-up]
• Rehabilitation [Срок оценки: From enrollment to 1 year follow-up]
• Smoking [Срок оценки: From enrollment to 1 year follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Китай · 3 центра

• Beijing Tsinghua Changgung Hospital — Пекин
• The First Affiliated Hospital of Shihezi University — Shihezi
• Beijing Tiantan Hospital — Пекин

Публикации

• 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 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. PMID 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. PMID 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. PMID 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. PMID 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 PMID 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 PMID 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. PMID 35703097

Идентификаторы

NCT: NCT06783049 · 2022YFC250494

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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