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| Name | Class |
|---|---|
| Institut d'Investigació Biomèdica de Bellvitge | OTHER |
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The primary objective of the study is to evaluate the efficacy of a telemedicine-based follow-up strategy compared with usual care in the management of patients with chronic heart failure (HF) at high risk of clinical events.
The HERMeS Trial (Heart failure Events reduction with Remote Monitoring and eHealth Support) is a multicenter, prospective, randomized, open label, observational investigator initiated study to assess the effect on cardiovascular mortality and non-fatal heart failure (HF) events of a telemedicine-based comprehensive management program for patients with chronic HF by means of remote daily telemonitoring of signs and symptoms of HF and remote structured follow-up using videoconference. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published.
In this study we aim to compare the strategy of providing nurse-based structured follow-up to high-risk chronic HF patients through planned contacts between health care providers and patients and/or caregivers in the basis of face-to-face on-site encounters (usual care) or provide the planned care using telemedicine with the combination of remote daily monitoring of signs and symptoms of HF (telemonitoring) and delivery of structured nurse-based follow-up health care using videoconference (tele-intervention).
The main hypothesis of the study is that daily telemonitoring of clinical variables and symptoms in high-risk patients with HF allows early detection of decompensations by decreasing the number of fatal cardiovascular events or non-fatal HF events. As a secondary hypothesis we assume that tele-intervention using telemedicine may help to optimise neurohormonal treatment and deliver appropriate education to high-risk patients with HF; and delivery of care in high risk patients with HF through the combination of remote monitoring and tele-intervention may translate into a reduction of fatal and non fatal HF-related events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring | Experimental | Structured follow-up in the basis of using telemedicine. Telemedicine will include daily signs and symptoms telemonitoring and structured follow-up by the means of video or audio-conference. |
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| Usual Care | No Intervention | Patients with usual care follow-up in a heart failure program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring | Procedure | The system (the home tele-healthcare platform) designed jointly by engineers and clinical personal to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring. The system allow weekly follow up through videoconferences. Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of cardiovascular death or non-fatal heart failure events. | Occurrence of cardiovascular death or non-fatal heart failure events (time to first event) during a follow-up period of 6 months. Non-fatal heart failure event is defined as a new episode of worsening of symptoms and signs consistent with acute decompensated HF requiring intravenous decongestive therapy (e.g. diuretics) either on an outpatient basis (day-case HF hospital) or in the emergency department (<24 hours) or requiring unplanned hospital admission (>24 hours) or complicating the course of a non-cardiovascular admission. | Six months after inclusion of the patient |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission (all-cause, HF and cardiovascular) rate and total number. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. |
| Days in hospital (all-cause, HF and cardiovascular). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep ComÃn Colet, MD,PhD | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40374486 | Derived | Yun S, Comin-Colet J, Calero-Molina E, Hidalgo E, Jose-Bazan N, Cobo Marcos M, Soria T, Llacer P, Fernandez C, Garcia-Pinilla JM, Cruzado C, Gonzalez-Franco A, Garcia-Marina EM, Morales-Rull JL, Sole C, Garcia-Romero E, Nunez J, Civera J, Fernandez C, Faraudo M, Moliner P, Formiga F, de-Juan Baguda J, Zegri-Reiriz I, Verdu-Rotellar JM, Vela E, Monterde D, Piera-Jimenez J, Carot-Sans G, Enjuanes C; HERMeS trial investigators group. Evaluation of mobile health technology combining telemonitoring and teleintervention versus usual care in vulnerable-phase heart failure management (HERMeS): a multicentre, randomised controlled trial. Lancet Digit Health. 2025 May;7(5):100866. doi: 10.1016/j.landig.2025.02.006. Epub 2025 May 14. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Comparison of both strategies at the end of follow-up.
| Six months after inclusion of the patient. |
| Rate of emergency visits. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. |
| Rate of non-fatal HF events. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. |
| Mortality for any cause and cardiovascular mortality. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. |
| Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale). | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. |
| Improvement of quality of life using a validated questionnaire (EUROQOL - 5D). | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. |
| Patient satisfaction using a Likert-type scale. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. |