Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients

Официальное название

Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients: Promoting Self-Management and Adherence to Treatment

Обзор

Cardiovascular diseases (CVD) are the leading cause of death worldwide, taking an estimated 17.9 million lives each year. The reduction of CVD-related mortality and morbidity is a key global health priority. Cardiac rehabilitation (CR) is a multi-factorial and comprehensive intervention in secondary prevention, being recommended in international guidelines. Core components in CR include patient assessment, physical activity counseling, nutritional counseling, risk factor control, patient education, and psychosocial management. CR has been shown to reduce mortality, hospital readmissions, costs, as well as to improve physical fitness, quality of life, and psychological well-being. However, despite the recommendations and proven benefits, acceptance and adherence remain low. Access to health technologies in all primary and secondary healthcare facilities can be essential to ensure that those in need receive treatment and counseling. Using mobile health (mHealth) solutions may contribute to more personalized and tailored patient recommendations according to their specific needs. Also, these technologies contribute to increasing the flexibility, quality, and efficiency of the services provided by health institutions. Time constraints, patient overpopulation, and complex guidelines require alternative solutions for real-time patient monitoring. Rapidly evolving e-health technology combined with clinical decision support systems (CDSS) provides an effective solution to these problems. There are several computerized CDSS for managing chronic diseases; however, to the best of our knowledge, there are none for the e-management of patients with CVD. The purpose of this transdisciplinary research project is to develop and evaluate a user-friendly, comprehensive CDSS for remote monitoring of CVD patients. The CDSS will suggest a monitoring plan for the patient, advise the mHealth tools (apps and wearables) adapted to patient needs, and collect data. The primary outcome will be the reduction of recurrent cardiovascular events (a composite of cardiovascular rehospitalization or urgent consultation, unplanned revascularization, cardiovascular mortality, or worsening heart failure).

Вмешательства

• Комбинированный продукт mHeart.4u
  The mHeart.4U is a multiple-components intervention entailing the adoption and use of technological devices and self-management recommendations tailored to behavioural modifications (e.g. physical exercise and dietary patterns)

Первичные конечные точки

• Recurrent cardiovascular event rates [Срок оценки: Two measurement timepoints: 3-month (T1) and the 6-month (T2)]

Вторичные конечные точки (4)

• Quality of life score (assessed by the MacNew Heart Disease Health-related Quality of Life questionnaire) [Срок оценки: Two measurement timepoints: 3-month (T1) and the 6-month (T2)]
• Adherence to treatment score (assessed by the Therapeutic Self-care Scale) [Срок оценки: Two measurement timepoints: 3-month (T1) and the 6-month (T2)]
• Body Mass Index (in Kg/m^2) [Срок оценки: Two measurement timepoints: 3-month (T1) and the 6-month (T2)]
• Health-Promoting Lifestyle score (assessed by the Health-Promoting Lifestyle Profile-II) [Срок оценки: Two measurement timepoints: 3-month (T1) and the 6-month (T2)]

Критерии участия

Критерии включения

• Patients attending the cardiology outpatient clinics after the onset of acute cardiac event OR
• Patients attending the cardiology outpatient clinics who are engaged in a structured Cardiac Rehabilitation program
• Be able to communicate with the researcher

Критерии исключения

• Participants will be excluded if they have New York Heart Association class III/IV heart failure, terminal disease, or significant non-cardio vascular disease exercise limitations.

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Rawstorn JC, Ball K, Oldenburg B, Chow CK, McNaughton SA, Lamb KE, Gao L, Moodie M, Amerena J, Nadurata V, Neil C, Cameron S, Maddison R. Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease. JMIR Res Protoc. 2020 Jan 27;9(1):e15022. doi: 10.2196/15 PMID 32012103
• Su JJ, Yu DSF, Paguio JT. Effect of eHealth cardiac rehabilitation on health outcomes of coronary heart disease patients: A systematic review and meta-analysis. J Adv Nurs. 2020 Mar;76(3):754-772. doi: 10.1111/jan.14272. Epub 2020 Feb 3. PMID 31769527
• Abreu A, Mendes M, Dores H, Silveira C, Fontes P, Teixeira M, Santa Clara H, Morais J. Mandatory criteria for cardiac rehabilitation programs: 2018 guidelines from the Portuguese Society of Cardiology. Rev Port Cardiol (Engl Ed). 2018 May;37(5):363-373. doi: 10.1016/j.repc.2018.02.006. Epub 2018 Apr 30. English, Portuguese. PMID 29724635
• Quaosar GMAA, Hoque MR, Bao Y. Investigating Factors Affecting Elderly's Intention to Use m-Health Services: An Empirical Study. Telemed J E Health. 2018 Apr;24(4):309-314. doi: 10.1089/tmj.2017.0111. Epub 2017 Oct 4. PMID 28976824
• Slater H, Campbell JM, Stinson JN, Burley MM, Briggs AM. End User and Implementer Experiences of mHealth Technologies for Noncommunicable Chronic Disease Management in Young Adults: Systematic Review. J Med Internet Res. 2017 Dec 12;19(12):e406. doi: 10.2196/jmir.8888. PMID 29233804
• Rawstorn JC, Gant N, Direito A, Beckmann C, Maddison R. Telehealth exercise-based cardiac rehabilitation: a systematic review and meta-analysis. Heart. 2016 Aug 1;102(15):1183-92. doi: 10.1136/heartjnl-2015-308966. Epub 2016 Mar 2. PMID 26936337
• Authors/Task Force Members; Ryden L, Grant PJ, Anker SD, Berne C, Cosentino F, Danchin N, Deaton C, Escaned J, Hammes HP, Huikuri H, Marre M, Marx N, Mellbin L, Ostergren J, Patrono C, Seferovic P, Uva MS, Taskinen MR, Tendera M, Tuomilehto J, Valensi P, Zamorano JL; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fag PMID 23996285
• Leal A, Paiva C, Hofer S, Amado J, Gomes L, Oldridge N. Evaluative and discriminative properties of the Portuguese MacNew Heart Disease Health-related Quality of Life Questionnaire. Qual Life Res. 2005 Dec;14(10):2335-41. doi: 10.1007/s11136-005-7213-x. PMID 16328913

Идентификаторы

NCT: NCT05196802 · mHEART.4U

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗