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Recruiting NCT06751641

Survey of Adult Participants Enrolled in Decentralized Clinical Trials

Observational Clinical Trial Incorporating Decentralized Elements

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: patient participating in a clinical trial incorporating decentralized elements..
Who it may be relevant to
Registry conditions: Clinical Trial Incorporating Decentralized Elements. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Longitudinal, Multicenter Survey of Adult Participants Enrolled in Decentralized Clinical Trials

Overview

Clinical trials (CTs) have become increasingly complex, requiring significant commitment from participants. Decentralized clinical trials (DCTs) offer an alternative by shifting some activities away from traditional sites to locations like the patient's home. This reduces the burden on participants, improves accessibility, and enhances recruitment and retention rates. DCTs leverage digital tools such as telemedicine, electronic consent, and wearable devices for data collection. These methods enable fewer site visits, lowering costs and integrating trials more seamlessly into participants' daily routines. This survey aims to assess the willingness of participants already enrolled in traditional CTs to engage in DCTs. Their prior experience with trial procedures allows them to provide valuable insights into the perceived benefits and feasibility of decentralized elements.

Detailed description

The purpose of this survey is to assess the interest of adults enrolled in a traditional interventional clinical trial involving a drug in participating in a clinical trial incorporating decentralized elements.

Interventions

  • Other patient participating in a clinical trial incorporating decentralized elements.
    participating in a clinical trial incorporating decentralized elements.

Primary outcome measures

  • To assess the willingness of adults already enrolled in an interventional clinical trial involving a drug to participate in a similar trial that incorporates one or more decentralized elements. [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

Adults. Patients or healthy volunteers, ambulatory, enrolled in an interventional clinical trial evaluating a drug and receiving the trial treatment(s) either at the investigative site and/or at their place of residence.

Exclusion criteria

Individuals who have not expressed their non-opposition to participating in the survey.

Individuals participating in a clinical trial with procedures that are not deemed translatable to decentralized procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

France · 1 center
  • CHU Nantes — Nantes

Identifiers

NCT: NCT06751641 · AP_LF_DeCTris_01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗