Decision Support Systems, ClinicalmHEART4UNCT05196802
Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients
A study testing mHeart.4u in people with Decision Support Systems, Clinical, run by Escola Superior de Enfermagem de Coimbra.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decision Support Systems, Clinical
- What is being tested?
- mHeart.4u
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients: Promoting Self-Management and Adherence to Treatment
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.
Read more
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
- Being tested
- mHeart.4u
- Keywords
- Decision Support Systems, Clinical, Telemedicine, cardiac rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHeart.4uCombination 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent cardiovascular event rates
This outcome is a composite of cardiovascular rehospitalization or urgent visit, unplanned revascularization, cardiovascular mortality, or worsening heart failure
Measured: 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)
The MacNew Heart Disease Health-related Quality of Life questionnaire consists of 27 items which fall into three domains (physical limitations domain scale, emotional function domain scale, and social function domain scale). Scoring of the MacNew is straight-forward. The maximum possible score in any domain is 7 (high quality of life) and the minimum is 1 (poor quality of life).
Measured: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Adherence to treatment score (assessed by the Therapeutic Self-care Scale)
The Therapeutic Self-care Scale total score (from 0 to 60 points) corresponds to a high level of performance in therapeutic self-care. The scale is designed to assess patients' ability to engage in four aspects of self-care: taking medications as prescribed by the doctor; identifying and managing symptoms; performing activities of daily living; and managing changes in condition.
Measured: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Body Mass Index (in Kg/m^2)
The Body Mass Index is a measure of body fat based on height and weight. It is calculated by a person's weight in kilograms divided by the square of height in meters.
Measured: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Health-Promoting Lifestyle score (assessed by the Health-Promoting Lifestyle Profile-II)
The Health-Promoting Lifestyle Profile-II consists of 52 health-promoting behavior items that are categorized into six subscales: health responsibility, spiritual growth, physical activity, interpersonal relationships, nutrition, and stress management. Each behavior is measured from 1 (never) to 4 (regularly). The total score of the scale ranges from 52 to 208 (higher scores represents healthier lifestyles).
Measured: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Decision Support Systems, ClinicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Enfermagem de Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Politécnico de Leiria
- Responsible party
- Principal investigator, Pedro Miguel Lopes de Sousa, Escola Superior de Enfermagem de Coimbra
- Investigators
- Pedro Sousa, PhD, Principal investigator, Nursing School of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196802
- Sponsor's protocol ID
- mHEART.4U
- Acronym
- mHEART4U
- Status last verified
- Jan 2022
- First submitted
- 21 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data sets that underlie results of the scientific publication will be considered for sharing with other researchers.
Publications
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.
PubMed 32012103Su 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.
PubMed 31769527Abreu 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.
PubMed 29724635Quaosar 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.
PubMed 28976824Slater 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.
PubMed 29233804Rawstorn 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.
PubMed 26936337Authors/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.
PubMed 23996285Leal 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.
PubMed 16328913Sousa 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.
PubMed 25389054Santos 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.
PubMed 32405300Ventura 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.
PubMed 35615041
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support System for Remote Monitoring of Cardiovascular Disease Patients: Promoting Self-Management and Adherence to Treatment
- ClinicalTrials.gov ID
- NCT05196802
- Acronym / sponsor ID
- mHEART4U / mHEART.4U
- Conditions
- Decision Support Systems, Clinical
- Keywords
- Decision Support Systems, Clinical, Telemedicine, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Escola Superior de Enfermagem de CoimbraUniversity, hospital or other
- Collaborators
- Instituto Politécnico de Leiria
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHeart.4u | Experimental | Combination Product: mHeart.4uThe 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. |
| Standard care | No intervention | –This arm will receive treatment and care according to the prevailing practice at each of the cardiac hospital units. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHeart.4uThe 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) | Combination product | mHeart.4u |
Primary outcome
Recurrent cardiovascular event rates
Time frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
This outcome is a composite of cardiovascular rehospitalization or urgent visit, unplanned revascularization, cardiovascular mortality, or worsening heart failure
4 secondary outcomes
Quality of life score (assessed by the MacNew Heart Disease Health-related Quality of Life questionnaire)
Time frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Adherence to treatment score (assessed by the Therapeutic Self-care Scale)
Time frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Body Mass Index (in Kg/m^2)
Time frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Health-Promoting Lifestyle score (assessed by the Health-Promoting Lifestyle Profile-II)
Time frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Background: PubMed 32012103Rawstorn 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.
- Background: PubMed 31769527Su 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.
- Background: PubMed 29724635Abreu 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.
- Background: PubMed 28976824Quaosar 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.
- Background: PubMed 29233804Slater 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.
- Background: PubMed 26936337Rawstorn 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.
- Background: PubMed 23996285Authors/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.
- Background: PubMed 16328913Leal 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.
- Background: PubMed 25389054Sousa 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.
- Background: PubMed 32405300Santos 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.
- Derived from this study: PubMed 35615041Ventura 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.
- Individual participant dataSharing planned: Yes. Individual participant data sets that underlie results of the scientific publication will be considered for sharing with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro Sousa, PhD principal investigator
Nursing School of Coimbra
Questions about this trial
What is this clinical trial studying?
A study testing mHeart.4u in people with Decision Support Systems, Clinical, run by Escola Superior de Enfermagem de Coimbra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro Sousa, PhD (+351 239 802 850, pmlsousa@esenfc.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent cardiovascular event rates (time frame: Two measurement timepoints: 3-month (T1) and the 6-month (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196802, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.