Dataset Information

Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS).

ABSTRACT:

Aims

The role of non-invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC) in patients recently admitted due to heart failure (HF) ('vulnerable phase' HF patients) is not well established. The aim of the Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS) trial is to assess the impact on clinical outcomes of implementing a TM service based on mobile health (mHealth), which includes remote daily monitoring of biometric data and symptom reporting (telemonitoring) combined with VC structured, nurse-based follow-up (teleintervention). The results will be compared with those of the comprehensive HF usual care (UC) strategy based on face-to-face on-site visits at the vulnerable post-discharge phase.

Methods and results

We designed a 24 week nationwide, multicentre, randomized, controlled, open-label, blinded endpoint adjudication trial to assess the effect on cardiovascular (CV) mortality and non-fatal HF events of a TM-based comprehensive management programme, based on mHealth, for patients with chronic HF. Approximately 508 patients with a recent hospital admission due to HF decompensation will be randomized (1:1) to either structured follow-up based on face-to-face appointments (UC group) or the delivery of health care using TM. The primary outcome will be a composite of death from CV causes or non-fatal HF events (first and recurrent) at the end of a 6 month follow-up period. Key secondary endpoints will include components of the primary event analysis, recurrent event analysis, and patient-reported outcomes.

Conclusions

The HERMeS trial will assess the efficacy of a TM-based follow-up strategy for real-world 'vulnerable phase' HF patients combining telemonitoring and teleintervention.

SUBMITTER: Yun S

PROVIDER: S-EPMC7754948 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS).

Yun Sergi S Enjuanes Cristina C Calero Esther E Hidalgo Encarnación E Cobo Marta M Llàcer Pau P García-Pinilla José Manuel JM González-Franco Álvaro Á Núñez Julio J Morales-Rull José Luis JL Beltrán Paola P Delso Cristina C Freixa-Pamias Román R Moliner Pedro P Corbella Xavier X Comín-Colet Josep J

ESC heart failure 20200917 6

<h4>Aims</h4>The role of non-invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC) in patients recently admitted due to heart failure (HF) ('vulnerable phase' HF patients) is not well established. The aim of the Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS) trial is to assess the impact on clinical outcomes of implementing a TM service based on mobile health (mHealth), which includes remote daily monitoring of biomet ...[more]

PMID: 32940428

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Project description:BackgroundHeart failure (HF) is one of the most common reasons for hospital admission and is a major cause of morbidity, mortality, and increasing health care costs. The EMPOWER study was a randomized trial that used remote monitoring technology to track patients' weight and diuretic adherence and a state-of-the-art approach derived from behavioral economics to motivate adherence to the reverse monitoring technology.ObjectiveThe goal was to explore patient and clinician perceptions of the program and its impact on perceived health outcomes and better understand why some patients or clinicians did better or worse than others in response to the intervention.ApproachThis was a retrospective qualitative study utilizing semi-structured interviews with 43 patients and 16 clinicians to understand the trial's processes, reflecting on successes and areas for improvement for future iterations of behavioral economic interventions.Key resultsMany patients felt supported, and they appreciated the intervention. Many also appreciated the lottery intervention, and while it was not an incentive for enrolling for many respondents, it may have increased adherence during the study. Clinicians felt that the intervention integrated well into their workflow, but the number of alerts was burdensome. Additionally, responses to alerts varied considerably by provider, perhaps because there are no professional guidelines for alerts unaccompanied by severe symptoms.ConclusionOur qualitative analysis indicates potential areas for additional exploration and consideration to design better behavioral economic interventions to improve cardiovascular health outcomes for patients with HF. Patients appreciated lottery incentives for adhering to program requirements; however, many were too far along in their disease progression to benefit from the intervention. Clinicians found the amount and frequency of electronic alerts burdensome and felt they did not improve patient outcomes.Trial registrationClinicalTrials.gov Identifier: NCT02708654.

Project description:BackgroundAround 50% of hospital readmissions due to heart failure are preventable, with lack of adherence to prescribed self-care as a driving factor. Remote tracking and reminders issued by mobile health devices could help to promote self-care, which could potentially reduce these readmissions.ObjectiveWe sought to investigate two factors: (1) feasibility of enrolling heart failure patients in a remote monitoring regimen that uses wireless sensors and patient-reported outcome measures; and (2) their adherence to using the study devices and completing patient-reported outcome measures.MethodsTwenty heart failure patients participated in piloting a remote monitoring regimen. Data collection included: (1) physical activity using wrist-worn activity trackers; (2) body weight using bathroom scales; (3) medication adherence using smart pill bottles; and (4) patient -reported outcomes using patient-reported outcome measures.ResultsWe evaluated 150 hospitalized heart failure patients and enrolled 20 individuals. Two factors contributed to 50% (65/130) being excluded from the study: smartphone ownership and patient discharge. Over the course of the study, 60.0% of the subjects wore the activity tracker for at least 70% of the hours, and 45.0% used the scale for more than 70% of the days. The pill bottle was used less than 10% of the days by 55.0% of the subjects.ConclusionsOur method of recruiting heart failure patients prior to hospital discharge may not be feasible as the enrollment rate was low. Once enrolled, the majority of subjects maintained a high adherence to wearing the activity tracker but low adherence to using the pill bottle and completing the follow-up surveys. Scale usage was fair, but it received positive reviews from most subjects. Given the observed usage and feedback, we suggest mobile health-driven interventions consider including an activity tracker and bathroom scale. We also recommend administering a shorter survey more regularly and through an easier interface.

Dataset Information

Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS).

Aims

Methods and results

Conclusions

Publications

Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS).

Similar Datasets

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