The INFluence of Remote monitoring on Anxiety/depRession, quality of lifE, and Device acceptance in ICD patients: a prospective, randomized, controlled, single-center trial.

Anxiety Arrhythmias, Cardiac / psychology Defibrillators, Implantable / psychology Female Follow-Up Studies Humans Male Middle Aged Monitoring, Physiologic / methods Patient Reported Outcome Measures Prospective Studies Quality of Life Single-Blind Method Surveys and Questionnaires Telemedicine / methods
Implantable cardioverter–defibrillator QoL Quality of life Remote device monitoring Telemedicine

Journal

Clinical research in cardiology : official journal of the German Cardiac Society
ISSN: 1861-0692
Titre abrégé: Clin Res Cardiol
Pays: Germany
ID NLM: 101264123

Informations de publication

Date de publication:
Jun 2021
Historique:
received: 24 11 2019
accepted: 07 05 2020
pubmed: 18 5 2020
medline: 19 11 2021
entrez: 18 5 2020
Statut: ppublish

Résumé

Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter-defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort. Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (- 0.4 vs. - 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM. The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.

Sections du résumé

BACKGROUND BACKGROUND
Impact of telemedicine with remote patient monitoring (RPM) in implantable cardioverter-defibrillator (ICD) patients on clinical outcomes has been investigated in various clinical settings with divergent results. However, role of RPM on patient-reported-outcomes (PRO) is unclear. The INFRARED-ICD trial aimed to investigate the effect of RPM in addition to standard-of-care on PRO in a mixed ICD patient cohort.
METHODS AND RESULTS RESULTS
Patients were randomized to RPM (n = 92) or standard in-office-FU (n = 88) serving as control group (CTL). At baseline and on a monthly basis over 1 year, study participants completed the EQ-5D questionnaire for the primary outcome Quality of Life (QoL), the Hospital Anxiety and Depression Scale, and the Florida Patient Acceptance Survey questionnaire for secondary outcomes. Demographic characteristics (82% men, mean age 62.3 years) and PRO at baseline were not different between RPM and CTL. Primary outcome analysis showed that additional RPM was not superior to CTL with respect to QoL over 12 months [+ 1.2 vs. + 3.9 points in CTL and RPM group, respectively (p = 0.24)]. Pre-specified analyses could not identify subgroups with improved QoL by the use of RPM. Neither levels of anxiety (- 0.4 vs. - 0.3, p = 0.88), depression (+ 0.3 vs. ± 0.0, p = 0.38), nor device acceptance (+ 1.1 vs. + 1.6, p = 0.20) were influenced by additional use of RPM.
CONCLUSION CONCLUSIONS
The results of the present study show that PRO were not improved by RPM in addition to standard-of-care FU. Careful evaluation and planning of future trials in selected ICD patients are warranted before implementing RPM in routine practice.

Identifiants

DOI: 10.1007/s00392-020-01667-0 PMID: 32417952 PMC: PMC8166667
pubmed: 32417952
doi: 10.1007/s00392-020-01667-0
pii: 10.1007/s00392-020-01667-0
pmc: PMC8166667
doi:

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

789-800

Références

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Auteurs

Florian Leppert (F)

School of Public Health, Bielefeld University, Bielefeld, Germany.

Johannes Siebermair (J)

Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Essen Medical School, University Duisburg-Essen, Essen, Germany.
Deutsches Zentrum für Herz-Kreislauferkrankungen (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.

Ulrich Wesemann (U)

Department of Psychiatry, Psychotherapy and Psychotraumatology, Bundeswehr Hospital, Berlin, Germany.

Eimo Martens (E)

Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Medizinische Klinik und Poliklinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.

Stefan M Sattler (SM)

Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Department of Cardiology, Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Stefan Scholz (S)

School of Public Health, Bielefeld University, Bielefeld, Germany.

Stefan Veith (S)

Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.

Wolfgang Greiner (W)

School of Public Health, Bielefeld University, Bielefeld, Germany.

Tienush Rassaf (T)

Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Essen Medical School, University Duisburg-Essen, Essen, Germany.

Stefan Kääb (S)

Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Deutsches Zentrum für Herz-Kreislauferkrankungen (DZHK), Partner Site Munich Heart Alliance, Munich, Germany.

Reza Wakili (R)

Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany. reza.wakili@uk-essen.de.
Department of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Essen Medical School, University Duisburg-Essen, Essen, Germany. reza.wakili@uk-essen.de.
Deutsches Zentrum für Herz-Kreislauferkrankungen (DZHK), Partner Site Munich Heart Alliance, Munich, Germany. reza.wakili@uk-essen.de.
ORCID: 0000-0002-6326-1537

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Classifications MeSH

questionsmedicales.fr › Comportement et mécanismes comportementaux › Émotions › Anxiété › The INFluence of Remote monitoring on...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Troubles du rythme cardiaque › The INFluence of Remote monitoring on...
questionsmedicales.fr › Équipement et fournitures › Prothèses et implants › Électrodes implantées › Défibrillateurs implantables › The INFluence of Remote monitoring on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études de suivi › The INFluence of Remote monitoring on...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › The INFluence of Remote monitoring on...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › The INFluence of Remote monitoring on...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Monitorage physiologique › The INFluence of Remote monitoring on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Enquêtes sur les soins de santé › Mesures des résultats rapportés par les patients › The INFluence of Remote monitoring on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › The INFluence of Remote monitoring on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › The INFluence of Remote monitoring on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en simple aveugle › The INFluence of Remote monitoring on...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › The INFluence of Remote monitoring on...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Télémédecine › The INFluence of Remote monitoring on...