Evidence map›Paper›PMID 32417952›Full record

Trial reportClinical research in cardiology : official journal of the German Cardiac Society2021

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

Florian Leppert, Johannes Siebermair, Ulrich Wesemann, Eimo Martens, Stefan M Sattler, Stefan Scholz, Stefan Veith, Wolfgang Greiner, Tienush Rassaf, Stefan Kääb and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.5field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Telemedical monitoring in patients with inborn cardiac disease - experience of a tertiary care centre.Mammalian genome : official journal of the International Mammalian Genome Society · 2023
    Article
  8. 2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
    Article
  9. Review
  10. Article
  11. The most used questionnaires for evaluating telemedicine services.BMC medical informatics and decision making · 2021
    Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 2 countries.

Florian Leppert *School of Public Health, Bielefeld University, Bielefeld, Germany.
Johannes Siebermair *Department of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Ulrich WesemannDepartment of Psychiatry, Psychotherapy and Psychotraumatology, Bundeswehr Hospital, Berlin, Germany.
Eimo MartensDepartment of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Stefan M SattlerDepartment of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Stefan ScholzSchool of Public Health, Bielefeld University, Bielefeld, Germany.
Stefan VeithDepartment of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Wolfgang GreinerSchool of Public Health, Bielefeld University, Bielefeld, Germany.
Tienush RassafDepartment of Cardiology and Vascular Medicine, West-German Heart and Vascular Center Essen, University of Essen Medical School, University Duisburg-Essen, Essen, Germany.
Stefan KääbDepartment of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany.
Reza WakiliDepartment of Medicine I, University Hospital Munich, Ludwig Maximilians University, Munich, Germany. reza.wakili@uk-essen.de.ORCID http://orcid.org/0000-0002-6326-1537
Bielefeld University · DEGerman Centre for Cardiovascular Research · DEBundeswehrkrankenhaus · DECopenhagen University Hospital · DKLudwig-Maximilians-Universität München · DETUM Klinikum · DEWest German Heart and Vascular Center Essen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImpact 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

resultsPatients 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.

conclusionThe 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.

Indexed as

Quality of LifeAnxietyArrhythmias, CardiacDefibrillators, ImplantableFemaleFollow-Up StudiesHumansMaleMiddle AgedMonitoring, PhysiologicPatient Reported Outcome MeasuresProspective StudiesSingle-Blind MethodSurveys and QuestionnairesTelemedicineImplantable cardioverter–defibrillatorQoLQuality of lifeRemote device monitoringTelemedicine

Identifiers

PMID32417952
PMCPMC8166667
OpenAlexW3024908254

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.