Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2023-06-08
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Routine management group
No interventions assigned to this group
Remote home management group assisted by community physicians
Remote monitoring assisted by community physicians
Patients upload data such as wristband data, blood pressure, weight through their mobile phones, while physicians can check the data on the platform. Upon detecting alerts, community physicians review participant-related medical information, conduct structured symptom assessments via "StarNet Home" platform/phone within 2 hours, and initiate protocol-guided interventions (e.g., diuretic adjustment for fluid overload).
Interventions
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Remote monitoring assisted by community physicians
Patients upload data such as wristband data, blood pressure, weight through their mobile phones, while physicians can check the data on the platform. Upon detecting alerts, community physicians review participant-related medical information, conduct structured symptom assessments via "StarNet Home" platform/phone within 2 hours, and initiate protocol-guided interventions (e.g., diuretic adjustment for fluid overload).
Eligibility Criteria
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Inclusion Criteria
2. Fulfill at least one of the following criteria：①History of chronic heart failure;②New-onset heart failure with LVEF \<50%；③New-onset heart failure with LVEF≧50%，E/e'≧15 and BNP\>400 pg/mL/NT-proBNP(\<50 years, \>450 pg/mL; 50\~75 years, \>900 pg/mL; \>75 years, \>1800 pg/mL)
3. Etiology: dilated cardiomyopathy, hypertensive heart disease, ischaemic cardiomyopathy, Non-severe valvular heart disease；
4. Primary post-discharge therapy: oral medication;
5. Sign the informed consent form.
Exclusion Criteria
2. Various correctable secondary causes of cardiac insufficiency including hyperthyroid heart disease, anaemic heart disease, uncorrected congenital heart disease; severe valvular heart disease (including severe stenosis or closure of organic aortic and mitral valves);
3. Patients with indications for pacemaker implantation but have not received a pacemaker implant;
4. Patients with chronic obstructive pulmonary disease accompanied by type II respiratory failure.
5. Patients who cannot understand and sign an informed consent form.
6. Patients with mental illness, pregnant women, and other special populations.
18 Years
ALL
No
Sponsors
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Jiangsu Taizhou People's Hospital
OTHER
Responsible Party
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Ming Chu
The deputy dean of the hospital
Principal Investigators
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Ming Chu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Taizhou People's Hospital
Locations
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Taizhou People's Hospital affiliated to Nanjing Medical University
Taizhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhang Y, Zhang J, Butler J, Yang X, Xie P, Guo D, Wei T, Yu J, Wu Z, Gao Y, Han X, Zhang X, Wen S, Anker SD, Filippatos G, Fonarow GC, Gan T, Zhang R; China-HF Investigators. Contemporary Epidemiology, Management, and Outcomes of Patients Hospitalized for Heart Failure in China: Results From the China Heart Failure (China-HF) Registry. J Card Fail. 2017 Dec;23(12):868-875. doi: 10.1016/j.cardfail.2017.09.014. Epub 2017 Oct 10.
Olivier B, Verdonck M, Caseleijn D. Digital technologies in undergraduate and postgraduate education in occupational therapy and physiotherapy: a scoping review. JBI Evid Synth. 2020 May;18(5):863-892. doi: 10.11124/JBISRIR-D-19-00210.
Sverdlov O, van Dam J, Hannesdottir K, Thornton-Wells T. Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development. Clin Pharmacol Ther. 2018 Jul;104(1):72-80. doi: 10.1002/cpt.1036. Epub 2018 Feb 23.
Urtnasan E, Joo EY, Lee KH. AI-Enabled Algorithm for Automatic Classification of Sleep Disorders Based on Single-Lead Electrocardiogram. Diagnostics (Basel). 2021 Nov 5;11(11):2054. doi: 10.3390/diagnostics11112054.
Yang Y, Yuan Y, Zhang G, Wang H, Chen YC, Liu Y, Tarolli CG, Crepeau D, Bukartyk J, Junna MR, Videnovic A, Ellis TD, Lipford MC, Dorsey R, Katabi D. Artificial intelligence-enabled detection and assessment of Parkinson's disease using nocturnal breathing signals. Nat Med. 2022 Oct;28(10):2207-2215. doi: 10.1038/s41591-022-01932-x. Epub 2022 Aug 22.
Attia ZI, Kapa S, Lopez-Jimenez F, McKie PM, Ladewig DJ, Satam G, Pellikka PA, Enriquez-Sarano M, Noseworthy PA, Munger TM, Asirvatham SJ, Scott CG, Carter RE, Friedman PA. Screening for cardiac contractile dysfunction using an artificial intelligence-enabled electrocardiogram. Nat Med. 2019 Jan;25(1):70-74. doi: 10.1038/s41591-018-0240-2. Epub 2019 Jan 7.
Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25.
Wu Y, Lin J, Gong B, Wang L, Ruan Z, Xu K. Cardiac Rehabilitation in Atrial Fibrillation Patients With Left Atrial Appendage Occlusion: A RANDOMIZED TRIAL. J Cardiopulm Rehabil Prev. 2022 Jul 1;42(4):266-271. doi: 10.1097/HCR.0000000000000693. Epub 2022 Apr 13.
Other Identifiers
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IIT202305
Identifier Type: -
Identifier Source: org_study_id
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