Evidence map›Paper›PMID 41781790›Full record

ArticleJournal of medical systems2026

Toward Effective Technology Support in DCTs: Insights from the Trials@Home Proof-of-Concept Trial RADIAL.

Theresa Weitlaner, Dimitrios Giannikopoulos, Bart Lagerwaard, Hannes Hilberger, Bernhard Neumayer, Mira G P Zuidgeest, Sten Hanke, Trials@Home Consortium

Registry-linked trialAbstract read
In one paragraph

Article in Journal of medical systems, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05780151 (Pan-European Proof-of-concept Study Comparing Decentralised Clinical Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT05780151 phase4completednot on this map

Pan-European Proof-of-concept Study Comparing Decentralised Clinical Trial (DCT) and Hybrid Approaches to Conventional Clinical Trial Approaches in Patients With Type 2 Diabetes Mellitus Treated With Toujeo®

TypeinterventionalSponsorMira ZuidgeestRan2023 to 2025Enrolled107ConditionsDiabetes Mellitus, Type 2ArmsMethodological intervention, Toujeo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Theresa WeitlanerInstitute of eHealth, FH JOANNEUM University of Applied Sciences, Graz, Austria. theresa.weitlaner@joanneum.com.ORCID http://orcid.org/0009-0005-7076-2929
Dimitrios GiannikopoulosBayer AG, Wuppertal, Germany.ORCID http://orcid.org/0009-0005-0168-3047
Bart LagerwaardJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID http://orcid.org/0000-0001-8558-2385
Hannes HilbergerInstitute of eHealth, FH JOANNEUM University of Applied Sciences, Graz, Austria.ORCID http://orcid.org/0000-0003-3867-0651
Bernhard NeumayerInstitute of eHealth, FH JOANNEUM University of Applied Sciences, Graz, Austria.ORCID http://orcid.org/0000-0002-4439-4799
Mira G P ZuidgeestJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID http://orcid.org/0000-0003-1463-8243
Sten HankeInstitute of eHealth, FH JOANNEUM University of Applied Sciences, Graz, Austria.ORCID http://orcid.org/0000-0003-3833-4252
Trials@Home Consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Decentralized clinical trials (DCTs) increasingly rely on digital tools such as wearable devices, mobile applications, and online platforms to enable remote data collection and participant engagement. While these technologies offer opportunities for greater convenience and continuous data capture, they also introduce operational complexity and require comprehensive technical support for participants, clinical site staff, and study teams. This paper reports on the design, implementation, use, and evaluation of a dedicated support framework in the European proof-of-concept trial RADIAL, part of the Trials@Home project, aimed at identifying effective components and operational practices for supporting DCTs. The framework included an open-source ticketing system for structured issue management, a restricted-access knowledge base (KB) with training materials and troubleshooting guides, and governance processes for escalation and quality monitoring. Key performance indicators were derived from system databases to track ticket volume, resolution times, and KB usage. Over the trial’s 17-month reporting period, 169 tickets were submitted across 90% of active clinical trial sites, with device-related problems accounting for 46% of requests and study app queries for 17%. Half of all tickets were resolved within three days, and most required two to six replies. The KB logged 696 searches and 4,350 article views, with highest engagement around training materials and device-related instructions. Findings indicate that a successful support framework for DCTs requires a combination of ticketing, accessible documentation, live support options, and continuous governance. Lessons from RADIAL underscore the importance of multilingual support, proactive training, and flexible workflows to effectively mitigate operational complexity and ensure reliable trial conduct. This trial was registered with identifier NCT05780151 in clinicaltrials.gov and under 2022-500,449-26-00 in the Clinical Trials Information System (CTIS) clinical trial database.

Indexed as

Decentralized clinical trialsHelpdeskKey performance indicatorKnowledge baseTechnology support systemTicketing system

Identifiers

PMID41781790
PMCPMC12960325

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.