Evidence map›Paper›PMID 33707523›Full record

Trial reportScientific reports2021

Proof-of-concept trial results of the HeartMan mobile personal health system for self-management in congestive heart failure.

Els Clays, Paolo Emilio Puddu, Mitja Luštrek, Giovanni Pioggia, Jan Derboven, Marilena Vrana, Johan De Sutter, Rita Le Donne, Anneleen Baert, Marko Bohanec and 11 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 9 pooled it
3.5field-weighted citation impact, top 6% 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

23 citing papers in PubMed, 9 syntheses or guidelines pooled it, 34 citations in OpenAlex.

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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

21 authors at 10 institutions in 3 countries.

Els ClaysDepartment of Public Health and Primary Care, Ghent University, Campus University Hospital Ghent, entrance 42, 4K3, Corneel Heymanslaan 10, 9000, Ghent, Belgium. els.clays@UGent.be.
Paolo Emilio PudduDepartment of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Mitja LuštrekDepartment of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenia.
Giovanni PioggiaInstitute for Biomedical Research and Innovation, Italian National Research Council, Messina, Italy.
Jan DerbovenMeaningful Interactions Lab, KU Leuven, Leuven, Belgium.
Marilena VranaEuropean Heart Network, Brussels, Belgium.
Johan De SutterDepartment of Cardiology, AZ Maria Middelares Ghent, Ghent, Belgium.
Rita Le DonneComplex Operative Unit of Pneumology and Telemedicine, San Camillo de Lellis General Hospital, Rieti, Italy.
Anneleen BaertDepartment of Public Health and Primary Care, Ghent University, Campus University Hospital Ghent, entrance 42, 4K3, Corneel Heymanslaan 10, 9000, Ghent, Belgium.
Marko BohanecDepartment of Knowledge Technologies, Jožef Stefan Institute, Ljubljana, Slovenia.
Maria Costanza CiancarelliDepartment of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Amos Adeyemo DawoduDepartment of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Michel De PauwDepartment of Internal Medicine, Ghent University, Ghent, Belgium.
Delphine De SmedtDepartment of Public Health and Primary Care, Ghent University, Campus University Hospital Ghent, entrance 42, 4K3, Corneel Heymanslaan 10, 9000, Ghent, Belgium.
Flavia MarinoInstitute for Biomedical Research and Innovation, Italian National Research Council, Messina, Italy.
Sofie PardaensCardiovascular Center, Onze-Lieve-Vrouw Hospital Aalst, Aalst, Belgium.
Michele Salvatore SchiaritiDepartment of Cardiovascular, Respiratory, Nephrological, Anesthesiological and Geriatric Sciences, Sapienza University of Rome, Rome, Italy.
Jakob ValičDepartment of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenia.
Marc VanderheydenCardiovascular Center, Onze-Lieve-Vrouw Hospital Aalst, Aalst, Belgium.
Aljoša VodopijaDepartment of Intelligent Systems, Jožef Stefan Institute, Ljubljana, Slovenia.
Gennaro TartariscoInstitute for Biomedical Research and Innovation, Italian National Research Council, Messina, Italy.
Jožef Stefan Institute · SISapienza University of Rome · ITGhent University Hospital · BENational Research Council · ITOnze Lieve Vrouwziekenhuis Hospital · BEAZ Maria Middelares · BEEuropean Heart Network · BEGhent University · BEInstitute for Biomedical Research and Innovation · ITKU Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study tested the effectiveness of HeartMan-a mobile personal health system offering decisional support for management of congestive heart failure (CHF)-on health-related quality of life (HRQoL), self-management, exercise capacity, illness perception, mental and sexual health. A randomized controlled proof-of-concept trial (1:2 ratio of control:intervention) was set up with ambulatory CHF patients in stable condition in Belgium and Italy. Data were collected by means of a 6-min walking test and a number of standardized questionnaire instruments. A total of 56 (34 intervention and 22 control group) participants completed the study (77% male; mean age 63 years, sd 10.5). All depression and anxiety dimensions decreased in the intervention group (p < 0.001), while the need for sexual counselling decreased in the control group (p < 0.05). Although the group differences were not significant, self-care increased (p < 0.05), and sexual problems decreased (p < 0.05) in the intervention group only. No significant intervention effects were observed for HRQoL, self-care confidence, illness perception and exercise capacity. Overall, results of this proof-of-concept trial suggest that the HeartMan personal health system significantly improved mental and sexual health and self-care behaviour in CHF patients. These observations were in contrast to the lack of intervention effects on HRQoL, illness perception and exercise capacity.

Indexed as

Proof of Concept StudySelf-ManagementTelemedicineAgedCase-Control StudiesFemaleHeart FailureHumansMaleMiddle AgedTreatment Outcome

Identifiers

PMID33707523
PMCPMC7970991
OpenAlexW3134041344

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.