{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T19:05:32Z","timestamp":1793127932068,"version":"4.5.0"},"reference-count":41,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2022,5,9]],"date-time":"2022-05-09T00:00:00Z","timestamp":1652054400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Cardiovascular diseases (CVD) are the leading cause of death globally, taking an estimated 17. 9 million lives each year. Cardiac rehabilitation is shown to reduce mortality and hospital readmissions, while improving physical fitness and quality of life. Despite the recommendations and proven benefits, acceptance and adherence remain low. Mobile health (mHealth) solutions may contribute to more personalized and tailored patient recommendations according to their specific needs. This study protocol aims to assess the effectiveness of a user-friendly, comprehensive Clinical Decision Support System (CDSS) for remote patient monitoring of CVD patients, primarily on the reduction of recurrent cardiovascular events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Analysis<\/jats:title><jats:p>The study will follow a multicenter randomized controlled design involving two cardiology units in the Center Region of Portugal. Prospective CVD patients will be approached by the healthcare staff at each unit and checked for eligibility according to the predefined inclusion\/exclusion criteria. The CDSS will suggest a monitoring plan for the patient, will advise the mHealth tools (apps and wearables) adapted to patient needs, and will collect data. The clinical study will start in January 2023.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>The success of the mHeart.4U intervention will be a step toward the use of technological interfaces as an integrating part of CR programs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and Dissemination<\/jats:title><jats:p>The study will undergo ethical revision by the Ethics Board of the two hospital units where the study will unfold. The study was registered in <jats:ext-link>ClinicalTrials.gov<\/jats:ext-link> on 18th January 2022 with the number NCT05196802. The study findings will be published in international peer-reviewed scientific journals and encounters and in a user-friendly manner to the society.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fpubh.2022.859890","type":"journal-article","created":{"date-parts":[[2022,5,9]],"date-time":"2022-05-09T06:51:00Z","timestamp":1652079060000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":14,"title":["A Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients: A Clinical Study Protocol"],"prefix":"10.3389","volume":"10","author":[{"given":"Filipa","family":"Ventura","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"Sousa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Anjos","family":"Dixe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paulo","family":"Ferreira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricardo","family":"Martinho","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara Sim\u00f5es","family":"Dias","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jo\u00e3o","family":"Morais","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lino M.","family":"Gon\u00e7alves","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2022,5,9]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"639","DOI":"10.1016\/j.pcad.2016.03.002","article-title":"Mobile phone interventions for the secondary prevention of cardiovascular disease","volume":"58","author":"Park","year":"2016","journal-title":"Prog Cardiovasc Dis"},{"key":"B2","doi-asserted-by":"publisher","first-page":"1151","DOI":"10.1016\/S0140-6736(17)32152-9","article-title":"Global, regional, and national age-sex specific mortality for 264 causes of death, 1980\u20132016: a systematic analysis for the global burden of disease study 2016","volume":"390","author":"Naghavi","year":"2017","journal-title":"Lancet"},{"key":"B3","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1177\/1757975914567513","article-title":"Prevention and control of noncommunicable diseases through evidence-based public health: implementing the NCD 2020 action plan","volume":"23","author":"Diem","year":"2016","journal-title":"Glob Health Promot."},{"key":"B4","doi-asserted-by":"publisher","first-page":"505","DOI":"10.1177\/2047487317750913","article-title":"Effectiveness, acceptability and usefulness of mobile applications for cardiovascular disease self-management: Systematic review with meta-synthesis of quantitative and qualitative data","volume":"25","author":"Coorey","year":"2018","journal-title":"Eur J Prev Cardiol"},{"key":"B5","doi-asserted-by":"publisher","first-page":"754","DOI":"10.1111\/jan.14272","article-title":"Effect of eHealth cardiac rehabilitation on health outcomes of coronary heart disease patients: a systematic review and meta-analysis","volume":"76","author":"Su","year":"2020","journal-title":"J Adv Nurs."},{"key":"B6","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.jacc.2015.10.044","article-title":"Exercise-Based cardiac rehabilitation for coronary heart disease: cochrane systematic review and meta-analysis","volume":"67","author":"Anderson","year":"2016","journal-title":"J Am Coll Cardiol."},{"key":"B7","doi-asserted-by":"publisher","first-page":"CD007130","DOI":"10.1002\/14651858.CD007130.pub4","article-title":"Home-based versus centre-based cardiac rehabilitation","volume":"6","author":"Anderson","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"key":"B8","doi-asserted-by":"publisher","first-page":"1","DOI":"10.2196\/15022","article-title":"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","volume":"9","author":"Rawstorn","year":"2020","journal-title":"JMIR Res Protoc."},{"key":"B9","doi-asserted-by":"publisher","first-page":"1157","DOI":"10.1161\/CIR.0000000000000232","article-title":"Current science on consumer use of mobile health for cardiovascular disease prevention","volume":"132","author":"Burke","year":"2015","journal-title":"Circulation."},{"key":"B10","doi-asserted-by":"publisher","first-page":"e10235","DOI":"10.2196\/10235","article-title":"Factors determining the success and failure of ehealth interventions: systematic review of the literature","volume":"20","author":"Granja","year":"2018","journal-title":"J Med Int Res"},{"key":"B11","doi-asserted-by":"publisher","first-page":"217","DOI":"10.1258\/jtt.2010.100407","article-title":"Cardiac rehabilitation outcomes in a conventional versus telemedicine-based programme","volume":"17","author":"Dalleck","year":"2011","journal-title":"J Telemed Telecare."},{"key":"B12","doi-asserted-by":"publisher","first-page":"118","DOI":"10.1002\/clc.23306","article-title":"Mobile health and cardiac rehabilitation in older adults","volume":"43","author":"Bostrom","year":"2020","journal-title":"Clin Cardiol."},{"key":"B13","doi-asserted-by":"publisher","first-page":"49","DOI":"10.1093\/ehjdh\/ztab011","article-title":"ESC working group on e-cardiology position paper: use of commercially available wearable technology for heart rate and activity tracking in primary and secondary cardiovascular prevention - in collaboration with the european heart rhythm association, European association of preventive cardiology, association of cardiovascular nursing and allied professionals, patient forum, and the digital health committee","volume":"2","author":"Jensen","year":"2021","journal-title":"Eur Heart J Digit Health."},{"key":"B14","doi-asserted-by":"publisher","first-page":"309","DOI":"10.1089\/tmj.2017.0111","article-title":"Investigating factors affecting elderly's intention to use m-Health services: an empirical study","volume":"24","author":"Quaosar","year":"2018","journal-title":"Telemed e-Health."},{"key":"B15","doi-asserted-by":"publisher","first-page":"43","DOI":"10.1186\/s12874-017-0324-6","article-title":"Implementation of clinical research trials using web-based and mobile devices: challenges and solutions","volume":"17","author":"Eagleson","year":"2017","journal-title":"BMC Med Res Methodol."},{"key":"B16","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1161\/JAHA.117.006997","article-title":"Self-care for the prevention and management of cardiovascular disease and stroke","volume":"6","author":"Riegel","year":"2017","journal-title":"J Am Heart Assoc."},{"key":"B17","doi-asserted-by":"publisher","first-page":"1","DOI":"10.2196\/jmir.8888","article-title":"End user and implementer experiences of mHealth technologies for noncommunicable chronic disease management in young adults: Systematic review","volume":"19","author":"Slater","year":"2017","journal-title":"J Med Internet Res."},{"key":"B18","doi-asserted-by":"publisher","first-page":"1183","DOI":"10.1136\/heartjnl-2015-308966","article-title":"Telehealth exercise-based cardiac rehabilitation: a systematic review and meta-analysis","volume":"102","author":"Rawstorn","year":"2016","journal-title":"Heart."},{"key":"B19","unstructured":"Global Mobile Health App Downloads 2013-2017. Statista\n            MikulicM\n          2019"},{"key":"B20","doi-asserted-by":"publisher","first-page":"655","DOI":"10.1089\/tmj.2015.0159","article-title":"A study to determine the most popular lifestyle smartphone applications and willingness of the public to share their personal data for health research","volume":"22","author":"Chen","year":"2016","journal-title":"Telemed e-Health"},{"key":"B21","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1186\/1748-5908-6-92","article-title":"Computerized clinical decision support systems for chronic disease management: a decision-maker-researcher partnership systematic review","volume":"6","author":"Roshanov","year":"2011","journal-title":"Implementation Sci."},{"key":"B22","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s12872-019-1262-5","article-title":"Effectiveness of eHealth cardiac rehabilitation on health outcomes of coronary heart disease patients: a randomized controlled trial protocol","volume":"19","author":"Su","year":"2019","journal-title":"BMC Cardiovasc Disord."},{"key":"B23","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s12872-018-0921-2","article-title":"A personal decision support system for heart failure management (heartman): study protocol of the heartman randomized controlled trial","volume":"18","author":"Baert","year":"2018","journal-title":"BMC Cardiovasc Disord."},{"key":"B24","doi-asserted-by":"publisher","first-page":"w20323","DOI":"10.4414\/smw.2020.20323","article-title":"Powering Swiss health care for the future: implementation science to bridge \u201cthe valley of death\u201d","volume":"150","author":"De Geest","year":"2020","journal-title":"Swiss Med Wkly"},{"key":"B25","doi-asserted-by":"publisher","first-page":"1205","DOI":"10.1001\/jama.2016.11409","article-title":"Pragmatic trials: practical answers to \u201creal world\u201d questions","volume":"316","author":"Sox","year":"2016","journal-title":"JAMA."},{"key":"B26","doi-asserted-by":"publisher","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","article-title":"Spirit 2013 statement: defining standard protocol items for clinical trials","volume":"158","author":"Chan","year":"2013","journal-title":"Ann Intern Med."},{"key":"B27","doi-asserted-by":"publisher","first-page":"363","DOI":"10.1016\/j.repce.2018.02.017","article-title":"Mandatory criteria for cardiac rehabilitation programs: 2018 guidelines from the Portuguese society of cardiology","volume":"37","author":"Abreu","year":"2018","journal-title":"Rev Port Cardiol"},{"key":"B28","doi-asserted-by":"publisher","first-page":"255","DOI":"10.1093\/eurheartj\/ehz486","article-title":"2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the task force for diabetes, pre-diabetes, and cardiovascular diseases of the European society of cardiology (ESC) and the European association for the study of diabetes (EASD)","volume":"41","author":"Cosentino","year":"2020","journal-title":"Eur Heart J"},{"key":"B29","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1093\/her\/cyz034","article-title":"Effects of the patient education strategy \u2018learning and coping' in cardiac rehabilitation on readmissions and mortality: a randomized controlled trial (LC-REHAB)","volume":"35","author":"Lynggaard","year":"2020","journal-title":"Health Educ Res"},{"key":"B30","doi-asserted-by":"publisher","first-page":"e031213","DOI":"10.1136\/bmjopen-2019-031213","article-title":"Hybrid cardiac rehabilitation trial (HYCARET): protocol of a randomised, multicentre, non-inferiority trial in South America","volume":"9","author":"Ser\u00f3n","year":"2019","journal-title":"BMJ Open"},{"key":"B31","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1186\/1477-7525-2-3","article-title":"The macnew heart disease health-related quality of life instrument: a summary","volume":"2","author":"H\u00f6fer","year":"2004","journal-title":"Health Qual Life Outcomes"},{"key":"B32","doi-asserted-by":"publisher","first-page":"2335","DOI":"10.1007\/s11136-005-7213-x","article-title":"Evaluative and discriminative properties of the Portuguese macnew heart disease health-related quality of life questionnaire","volume":"14","author":"Leal","year":"2005","journal-title":"Qual Life Res."},{"key":"B33","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1177\/084456211404600103","article-title":"Development and validation of a self-care ability measure","volume":"15","author":"Sidani","year":"2014","journal-title":"Can J Nurs Res Arch."},{"key":"B34","first-page":"426","article-title":"Cultural adaptation and psychometric properties of the Portuguese version of the therapeutic self-care scale","volume":"7","author":"Cardoso","year":"2014","journal-title":"Int J Caring Sci"},{"key":"B35","unstructured":"Psychometric Evaluation of the Health- Promoting Lifestyle Profile II (Unpublished manuscript). University of Nebraska Medical Center\n            WalkerS\n            Hill-PolereckyD\n          1996"},{"key":"B36","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1111\/2047-3095.12065","article-title":"Measuring health-promoting behaviours: cross-cultural validation of the health-promoting lifestyle profile-II","volume":"26","author":"Sousa","year":"2015","journal-title":"Int J Nurs Knowl"},{"key":"B37","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1155\/2020\/1639634","article-title":"The role of cardiovascular risk assessment in preventive medicine: a perspective from Portugal primary health-care cardiovascular risk assessment","volume":"2020","author":"Santos","year":"2020","journal-title":"J Environ Public Health."},{"key":"B38","doi-asserted-by":"publisher","first-page":"184","DOI":"10.1136\/bmjinnov-2019-000418","article-title":"Mobile health in cardiac patients: an overview on experiences and challenges of stakeholders involved in daily use and development","volume":"6","author":"Kauw","year":"2020","journal-title":"BMJ Innov"},{"key":"B39","doi-asserted-by":"publisher","first-page":"101","DOI":"10.1016\/j.cvdhj.2021.01.003","article-title":"Why digital health trials can fail: lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation","volume":"2","author":"Olivier","year":"2021","journal-title":"Cardiovasc Digit Health J"},{"key":"B40","doi-asserted-by":"publisher","first-page":"407","DOI":"10.1111\/hex.12468","article-title":"Elaboration of the Gothenburg model of person-centred care","volume":"20","author":"Britten","year":"2017","journal-title":"Health Expectations."},{"key":"B41","doi-asserted-by":"publisher","first-page":"40","DOI":"10.7326\/M17-0046","article-title":"Consort statement for randomized trials of nonpharmacologic treatments: a 2017 update and a consort extension for nonpharmacologic trial Abstracts","volume":"167","author":"Boutron","year":"2017","journal-title":"Ann Intern Med."}],"container-title":["Frontiers in Public Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2022.859890\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,9]],"date-time":"2022-05-09T06:51:04Z","timestamp":1652079064000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2022.859890\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,9]]},"references-count":41,"alternative-id":["10.3389\/fpubh.2022.859890"],"URL":"https:\/\/doi.org\/10.3389\/fpubh.2022.859890","relation":{},"ISSN":["2296-2565"],"issn-type":[{"value":"2296-2565","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,9]]},"article-number":"859890"}}