Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients

NCT05196802 | Not Yet Recruiting

• 1 other identifier: mHEART.4U
• Study Type: interventional
• Target: 212
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Decision Support Systems, Clinical

Keywords

Decision Support Systems, Clinical; Telemedicine; cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• Recurrent cardiovascular event rates

  This outcome is a composite of cardiovascular rehospitalization or urgent visit, unplanned revascularization, cardiovascular mortality, or worsening heart failure

  Two measurement timepoints: 3-month (T1) and the 6-month (T2)

Secondary Outcomes (4)

• Quality of life score (assessed by the MacNew Heart Disease Health-related Quality of Life questionnaire)

  Two measurement timepoints: 3-month (T1) and the 6-month (T2)

• Adherence to treatment score (assessed by the Therapeutic Self-care Scale)

  Two measurement timepoints: 3-month (T1) and the 6-month (T2)

• Body Mass Index (in Kg/m^2)

  Two measurement timepoints: 3-month (T1) and the 6-month (T2)

• Health-Promoting Lifestyle score (assessed by the Health-Promoting Lifestyle Profile-II)

  Two measurement timepoints: 3-month (T1) and the 6-month (T2)

Other Outcomes (1)

• Cardiovascular risk assessed by the Systematic COronary Risk Evaluation (SCORE)

  Baseline

Study Arms (2)

mHeart.4u

EXPERIMENTAL

The mHEART.4U intervention includes the use of an online Clinical Decision Support System (CDSS) for remote patient monitoring. According to the patient needs and profile, the CDSS will suggest a monitoring plan for the patient. The mHEART.4U kit will include mobile apps and wearables, such as heart rate, blood pressure, peripheral oxygen saturation (SpO2), sleep and step trackers, symptoms, lifestyle self-monitoring tools, medication reminders or motivational resources. The intervention length will be 6 months and will take into account the most recent guidelines on Cardiac Rehabilitation.

Combination Product: mHeart.4u

Standard care

NO INTERVENTION

This arm will receive treatment and care according to the prevailing practice at each of the cardiac hospital units.

Interventions

mHeart.4u COMBINATION_PRODUCT

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)

mHeart.4u

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Enfermagem de Coimbra: lead
• Instituto Politécnico de Leiria: collaborator

Related Publications (11)

• 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: 10.2196/15022.

  PMID: 32012103 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; De Backer G, Sirnes PA, Ezquerra EA, Avogaro A, Badimon L, Baranova E, Baumgartner H, Betteridge J, Ceriello A, Fagard R, Funck-Brentano C, Gulba DC, Hasdai D, Hoes AW, Kjekshus JK, Knuuti J, Kolh P, Lev E, Mueller C, Neyses L, Nilsson PM, Perk J, Ponikowski P, Reiner Z, Sattar N, Schachinger V, Scheen A, Schirmer H, Stromberg A, Sudzhaeva S, Tamargo JL, Viigimaa M, Vlachopoulos C, Xuereb RG. ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, pre-diabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J. 2013 Oct;34(39):3035-87. doi: 10.1093/eurheartj/eht108. Epub 2013 Aug 30. No abstract available.

  PMID: 23996285 BACKGROUND

• 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 BACKGROUND

• Sousa P, Gaspar P, Vaz DC, Gonzaga S, Dixe MA. Measuring health-promoting behaviors: cross-cultural validation of the Health-Promoting Lifestyle Profile-II. Int J Nurs Knowl. 2015 Apr;26(2):54-61. doi: 10.1111/2047-3095.12065. Epub 2014 Nov 11.

  PMID: 25389054 BACKGROUND

• Santos P. The Role of Cardiovascular Risk Assessment in Preventive Medicine: A Perspective from Portugal Primary Health-Care Cardiovascular Risk Assessment. J Environ Public Health. 2020 Jan 30;2020:1639634. doi: 10.1155/2020/1639634. eCollection 2020.

  PMID: 32405300 BACKGROUND

• Ventura F, Sousa P, Dixe MA, Ferreira P, Martinho R, Dias SS, Morais J, Goncalves LM. A Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients: A Clinical Study Protocol. Front Public Health. 2022 May 9;10:859890. doi: 10.3389/fpubh.2022.859890. eCollection 2022.

  PMID: 35615041 DERIVED

Study Officials

• Pedro Sousa, PhD

  Nursing School of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Sousa, PhD

CONTACT

+351 239 802 850; pmlsousa@esenfc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 19, 2022
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will become available within three months after publication of the scientific report of the RCT for a period of months
• Access Criteria: Access criteria will be defined upon elaboration of the IPD plan and will be assessed by the principal investigator.