Evidence map›Paper›PMID 39608860›Full record

ArticleOpen heart2024

Partnering RemoTe monitoring of Implanted Cardiac devices with Intelligent PATient Engagement - PARTICIPATE trial: a protocol for a randomised controlled trial.

Brodie Sheahen, Liliana Laranjo, Gopal Sivagangabalan, Tim Shaw, Aravinda Thiagalingam, Clara K Chow

Abstract readClinical Trial Protocol
In one paragraph

Article in Open heart, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

6 authors.

Brodie SheahenWestmead Applied Research Centre, The University of Sydney Westmead Applied Research Centre, Westmead, New South Wales, Australia bshe0551@uni.sydney.edu.au.ORCID 0009-0003-0110-5402
Liliana LaranjoWestmead Applied Research Centre, The University of Sydney Westmead Applied Research Centre, Westmead, New South Wales, Australia.
Gopal SivagangabalanWestmead Applied Research Centre, The University of Sydney Westmead Applied Research Centre, Westmead, New South Wales, Australia.
Tim ShawWestmead Applied Research Centre, The University of Sydney Westmead Applied Research Centre, Westmead, New South Wales, Australia.
Aravinda ThiagalingamWestmead Applied Research Centre, The University of Sydney Westmead Applied Research Centre, Westmead, New South Wales, Australia.
Clara K ChowWestmead Applied Research Centre, The University of Sydney Westmead Applied Research Centre, Westmead, New South Wales, Australia.ORCID 0000-0003-4693-0038

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCardiac implantable electronic devices (CIED) can transfer data to the healthcare team, remotely. National and international cardiac organisations recommend all patients use this technology, however patient engagement is suboptimal. Previously, in cardiovascular patients, SMS messaging services have shown improvements in patient engagement and subsequent health outcomes. This paper describes the protocol and intervention of a randomised controlled trial (RCT) to assess the feasibility of a novel CIED remote monitoring SMS patient support programme on self-efficacy in managing CIED and cardiovascular health following CIED implantation. METHODS/ANALYSIS: A two-arm RCT will be conducted of 100 participants with 1:1 allocation to intervention or control. Participants awaiting-CIED or immediately post-CIED implantation from sites throughout Australia will be invited to partake. The intervention group will receive regular SMS communication with a range of educational and self-efficacy resources, in conjunction with engagement initiatives following CIED clinical issue detection. The control group will receive CIED remote monitoring education and clinical issue management as per standard practice at their respective sites. The primary outcome will assess the patient's capacity to manage their CIED as measured by the 'Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation Scale'. Secondary outcomes will assess participant's ability to manage their cardiovascular condition, CIED remote monitoring, quality of life, impact on health service utilisation, cardiovascular behavioural risk factor change and motivation to improve cardiovascular health. A sample size of 100 will have a 90% power to detect a minimum difference of 1.07 in the 'Self-Efficacy Expectations After Implantable Cardioverter Defibrillator Implantation Scale' between the intervention and control group with an alpha value of 0.05. ETHICS AND DISSEMINATION: Ethics approval for this study has been obtained from the Western Sydney Local Health District Human Research Ethics Committee. The project results will be published in peer-reviewed journals, at scientific meetings and in the media. TRIAL REGISTRATION NUMBER: ACTRN12623000702617.

Indexed as

Defibrillators, ImplantablePatient ParticipationRandomized Controlled Trials as TopicAustraliaElectric CountershockFeasibility StudiesHumansPacemaker, ArtificialQuality of LifeRemote Sensing TechnologySelf EfficacyTelemedicineText MessagingArrhythmias, CardiacDefibrillators, ImplantableEducation, MedicalPacemaker, ArtificialTelemedicine

Identifiers

PMID39608860
PMCPMC11603830

What OpenQuestion holds

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LicenceCC BY-NC
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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.