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Vitalera has implemented a cloud platform for the telemonitoring of chronic patients through portable medical devices and an alarm-based system that issues health alerts when a patient's biomedical measurement is outside a predefined clinical range. The platform frees doctors and caregivers from reviewing individual patient data for abnormalities, speeding up the decision-making process and reducing hospital visits. With this study we intend to validate the efficacy of the app for patients and digital platform for medical professionals, evaluating the increase in the quality of life of patients and measuring the reduction in the incidence of the main critical events of HF. In addition, the study will validate the new API interoperability standards and platform architecture and will assess the usability of the platform by delivering satisfaction questionnaires to patients and professionals at the end of the study.
This study is being carried out within the framework of a European project promoted by the European Innovation Council (EIC).
This is a randomized controlled trial involving a Spanish network of hospitals. The study consists of continuous remote patient monitoring using vitalera's digital platform and the supplied devices (blood pressure monitor, wearable, scale and oximeter). For 3 months, a total of 250 patients suffering from HF will have their physiological constants monitored.
Patients will be included in the study based on the eligibility criteria and must complete the informed consent provided. Each hospital will decide when to include their patients according to their particular clinical practice. The recruitment period is defined as 3 months. That means patients will be incorporated into the study from its start until the third month. The last subject included in the study will then finish the study after six months from the first day of the study. Medical professionals from each hospital will be in charge of recruiting the participants. The recruitment rate is specific for each hospital, and it may vary depending on the month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care (UC) | No Intervention | The follow-up of the patients in the UC arm will be carried out in accordance with the usual clinical practice of each recruitment center. All recruiting centers have active and mature HF programs in place and therefore each center will decide how to follow up the patient. However, medical professionals will be required to register each patient on the platform, enter their baseline data (sociodemographics and risk factors) and enter all possible clinical events (death, non-fatal HF event, hospitalization or emergency room visit). that the patient could suffer during the entire follow-up period. The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center. | |
| Telemonitoring (TM) | Experimental | Patients in the TM arm will be followed up with the vitalera platform and app. Physiological parameters (measured periodically), socio-demographic data, risk factors, medication tracking, symptomatology questionnaire for patients, NYHA-class, clinical interventions, health questionnaire answers, classified alarms with their respective timestamp and annotation by the MD, and measurement ranges for each personalized alarm and their changes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitalera telemonitoring platform | Other | Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Scale Between Baseline and 3-months Follow-up | Quality of life measured with the Minnesota Living with Heart Failure scale. Scale from 0 to 105. The lower the score the better outcome. | 3 months |
| Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up. | Change in the proportion of patients adherent to treatment measured with SMAQ between start and end of the study. This questionnaire consists of six questions that evaluate different aspects of patient compliance with treatment: forgetfulness, routine, adverse effects, and a quantification of omissions. A patient is classified as non-compliant (non-adherent) if he/she responds to any of the questions with a non-adherence answer, and in terms of quantification, if the patient has lost more than two doses during the last week or has not taken medication during more than two complete days during the last three months. Then we compute the proportion of adherent patients at baseline and 3-months follow-up and compute the change in proportion. | 3 months |
| Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up | Patient's self-care behavior measured with The European Heart Failure Self-Care Behavior Scale. Scale from 9 to 45. The higher the score the poorer self-care. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality From Any Cause | Number of deaths during the study period | 3 months |
| Number of Hospital Readmissions | Total number of hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta MD Farrero | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Dénia | Denia | Alacant | 03700 | Spain | ||
| Hospital d'Alcoi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27942354 | Background | Tripoliti EE, Papadopoulos TG, Karanasiou GS, Naka KK, Fotiadis DI. Heart Failure: Diagnosis, Severity Estimation and Prediction of Adverse Events Through Machine Learning Techniques. Comput Struct Biotechnol J. 2016 Nov 17;15:26-47. doi: 10.1016/j.csbj.2016.11.001. eCollection 2017. | |
| 35083827 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care (UC) | The follow-up of the patients in the UC arm will be carried out in accordance with the usual clinical practice of each recruitment center. All recruiting centers have active and mature HF programs in place and therefore each center will decide how to follow up the patient. However, medical professionals will be required to register each patient on the platform, enter their baseline data (sociodemographics and risk factors) and enter all possible clinical events (death, non-fatal HF event, hospitalization or emergency room visit). that the patient could suffer during the entire follow-up period. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study. The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center. |
| FG001 | Telemonitoring (TM) | Patients in the TM arm will be followed up with the vitalera platform and app. Physiological parameters (measured periodically), socio-demographic data, risk factors, medication tracking, symptomatology questionnaire for patients, NYHA-class, clinical interventions, health questionnaire answers, classified alarms with their respective timestamp and annotation by the MD, and measurement ranges for each personalized alarm and their changes. vitalera telemonitoring platform: Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients that abandoned the study (10 patients) weren't considered for analysis. Those considered for all the analysis were the ones that completed plus the deseased patients (2 patients).
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care (UC) | The follow-up of the patients in the UC arm will be carried out in accordance with the usual clinical practice of each recruitment center. All recruiting centers have active and mature HF programs in place and therefore each center will decide how to follow up the patient. However, medical professionals will be required to register each patient on the platform, enter their baseline data (sociodemographics and risk factors) and enter all possible clinical events (death, non-fatal HF event, hospitalization or emergency room visit). that the patient could suffer during the entire follow-up period. The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quality of Life Scale Between Baseline and 3-months Follow-up | Quality of life measured with the Minnesota Living with Heart Failure scale. Scale from 0 to 105. The lower the score the better outcome. | Posted | Median | 95% Confidence Interval | units on a scale | 3 months |
|
During 3-month follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care (UC) | The follow-up of the patients in the UC arm will be carried out in accordance with the usual clinical practice of each recruitment center. All recruiting centers have active and mature HF programs in place and therefore each center will decide how to follow up the patient. However, medical professionals will be required to register each patient on the platform, enter their baseline data (sociodemographics and risk factors) and enter all possible clinical events (death, non-fatal HF event, hospitalization or emergency room visit). that the patient could suffer during the entire follow-up period. In addition, patients will use the app only to answer to health questionnaires in order to stardardize the responses from both group and evaluate the outcomes of the study. The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-cause hospitalizaton | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visit to medical emergencies | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Data Scientist of vitalera | vitalera (FollowHealth SL) | +34644499760 | val-hic@humanitcare.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2023 | Jan 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2024 | Jan 9, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 3 months |
| Number of Visits to the Emergency Room Due to HF Decompensation | Total number of visits with intravenous decongestive therapy | 3 months |
| Number of Emergency Visits for CV Causes | Total number of visits due to cardiovascular causes | 3 months |
| Alcoy |
| Alicante |
| 03801 |
| Spain |
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain |
| Hospital de Vinalopó | Elche | Alicante | 03292 | Spain |
| Hospital de Terrassa | Terrassa | Barcelona | 08227 | Spain |
| Corporació de Salut del Maresme i la Selva (Hospital de Blanes-Hospital de Calella) | Blanes | Girona | 17300 | Spain |
| Hospital de Torrejón | Torrejón de Ardoz | Madrid | 28850 | Spain |
| Hospital Universitari Sant Joan de Reus | Reus | Tarragona | 43204 | Spain |
| Hospital ClÃnic de Barcelona | Barcelona | 08036 | Spain |
| Hospital ClÃnico Lozano Blesa de Zaragoza | Zaragoza | 50009 | Spain |
| Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333. |
| 12798449 | Background | Schiff GD, Fung S, Speroff T, McNutt RA. Decompensated heart failure: symptoms, patterns of onset, and contributing factors. Am J Med. 2003 Jun 1;114(8):625-30. doi: 10.1016/s0002-9343(03)00132-3. |
| 31179018 | Background | Brahmbhatt DH, Cowie MR. Remote Management of Heart Failure: An Overview of Telemonitoring Technologies. Card Fail Rev. 2019 May 24;5(2):86-92. doi: 10.15420/cfr.2019.5.3. eCollection 2019 May. |
| 19687005 | Background | Scherr D, Kastner P, Kollmann A, Hallas A, Auer J, Krappinger H, Schuchlenz H, Stark G, Grander W, Jakl G, Schreier G, Fruhwald FM; MOBITEL Investigators. Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. J Med Internet Res. 2009 Aug 17;11(3):e34. doi: 10.2196/jmir.1252. |
| 27140340 | Background | Koulaouzidis G, Iakovidis DK, Clark AL. Telemonitoring predicts in advance heart failure admissions. Int J Cardiol. 2016 Aug 1;216:78-84. doi: 10.1016/j.ijcard.2016.04.149. Epub 2016 Apr 21. |
| 21444883 | Background | Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873-80. doi: 10.1161/CIRCULATIONAHA.111.018473. Epub 2011 Mar 28. |
| 35040610 | Background | Lee S, Chu Y, Ryu J, Park YJ, Yang S, Koh SB. Artificial Intelligence for Detection of Cardiovascular-Related Diseases from Wearable Devices: A Systematic Review and Meta-Analysis. Yonsei Med J. 2022 Jan;63(Suppl):S93-S107. doi: 10.3349/ymj.2022.63.S93. |
| 26391638 | Background | Guidi G, Pollonini L, Dacso CC, Iadanza E. A multi-layer monitoring system for clinical management of Congestive Heart Failure. BMC Med Inform Decis Mak. 2015;15 Suppl 3(Suppl 3):S5. doi: 10.1186/1472-6947-15-S3-S5. Epub 2015 Sep 4. |
| 19147463 | Background | Jaarsma T, Arestedt KF, Martensson J, Dracup K, Stromberg A. The European Heart Failure Self-care Behaviour scale revised into a nine-item scale (EHFScB-9): a reliable and valid international instrument. Eur J Heart Fail. 2009 Jan;11(1):99-105. doi: 10.1093/eurjhf/hfn007. |
| 27255686 | Background | Roque NA, Boot WR. A New Tool for Assessing Mobile Device Proficiency in Older Adults: The Mobile Device Proficiency Questionnaire. J Appl Gerontol. 2018 Feb;37(2):131-156. doi: 10.1177/0733464816642582. Epub 2016 Apr 11. |
| 26887590 | Background | Bilbao A, Escobar A, Garcia-Perez L, Navarro G, Quiros R. The Minnesota living with heart failure questionnaire: comparison of different factor structures. Health Qual Life Outcomes. 2016 Feb 17;14:23. doi: 10.1186/s12955-016-0425-7. |
| BG001 | Telemonitoring (TM) | Patients in the TM arm will be followed up with the vitalera platform and app. Physiological parameters (measured periodically), socio-demographic data, risk factors, medication tracking, symptomatology questionnaire for patients, NYHA-class, clinical interventions, health questionnaire answers, classified alarms with their respective timestamp and annotation by the MD, and measurement ranges for each personalized alarm and their changes. vitalera telemonitoring platform: Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NYHA class | The NYHA Functional Classification assesses heart failure severity based on physical activity limitations and symptoms like dyspnea, fatigue, and palpitations. It guides treatment decisions and monitors progression: Class I: No symptoms with ordinary activity. Class II: Slight limitation; symptoms with ordinary activity. Class III: Marked limitation; symptoms with less than ordinary activity. Class IV: Symptoms at rest or with minimal activity. Ref: McDonagh, et al. "2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure(...)" European Heart Journal | Count of Participants | Participants |
|
| LVEF categorical | Left Ventricular Ejection Fraction (LVEF) measures the percentage of blood the left ventricle pumps with each heartbeat, essential for heart failure (HF) classification: HFrEF: LVEF ≤ 40% (reduced) HFmrEF: LVEF 41-49% (mildly reduced) HFpEF: LVEF ≥ 50% (preserved) HFimpEF: Previously ≤ 40%, now > 40% with improvement LVEF guides HF diagnosis, treatment, and prognosis. McDonagh, et al. "2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure (...)" European heart journal 42.36 (2021): 3599-3726. | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Education level | Count of Participants | Participants |
|
| Does the patient have caretaker? | Count of Participants | Participants |
|
| Number of people living with the patient | Mean | Standard Deviation | people |
|
| Smoker | Count of Participants | Participants |
|
| Alcohol use | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
|
| Heart disease history | Count of Participants | Participants |
|
| OG001 | Telemonitoring (TM) | Patients in the TM arm will be followed up with the vitalera platform and app. Physiological parameters (measured periodically), socio-demographic data, risk factors, medication tracking, symptomatology questionnaire for patients, NYHA-class, clinical interventions, health questionnaire answers, classified alarms with their respective timestamp and annotation by the MD, and measurement ranges for each personalized alarm and their changes. vitalera telemonitoring platform: Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app |
|
|
|
| Primary | Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up. | Change in the proportion of patients adherent to treatment measured with SMAQ between start and end of the study. This questionnaire consists of six questions that evaluate different aspects of patient compliance with treatment: forgetfulness, routine, adverse effects, and a quantification of omissions. A patient is classified as non-compliant (non-adherent) if he/she responds to any of the questions with a non-adherence answer, and in terms of quantification, if the patient has lost more than two doses during the last week or has not taken medication during more than two complete days during the last three months. Then we compute the proportion of adherent patients at baseline and 3-months follow-up and compute the change in proportion. | Posted | Number | proportion of participants | 3 months |
|
|
|
|
| Primary | Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up | Patient's self-care behavior measured with The European Heart Failure Self-Care Behavior Scale. Scale from 9 to 45. The higher the score the poorer self-care. | Posted | Median | 95% Confidence Interval | units on a scale | 3 months |
|
|
|
|
| Secondary | Mortality From Any Cause | Number of deaths during the study period | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Hospital Readmissions | Total number of hospitalizations | Posted | Number | hospitalizations | 3 months |
|
|
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| Secondary | Number of Visits to the Emergency Room Due to HF Decompensation | Total number of visits with intravenous decongestive therapy | Posted | Number | visits to emergency room | 3 months |
|
|
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| Secondary | Number of Emergency Visits for CV Causes | Total number of visits due to cardiovascular causes | Posted | Number | visits to emergency room | 3 months |
|
|
|
| 0 |
| 43 |
| 9 |
| 43 |
| 3 |
| 43 |
| EG001 | Telemonitoring (TM) | Patients in the TM arm will be followed up with the vitalera platform and app. Physiological parameters (measured periodically), socio-demographic data, risk factors, medication tracking, symptomatology questionnaire for patients, NYHA-class, clinical interventions, health questionnaire answers, classified alarms with their respective timestamp and annotation by the MD, and measurement ranges for each personalized alarm and their changes. vitalera telemonitoring platform: Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app | 2 | 46 | 7 | 46 | 1 | 46 |
| Urgent visit with intravenous decongestive therapy | Cardiac disorders | Non-systematic Assessment |
|
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