Survey of Adult Participants Enrolled in Decentralized Clinical Trials

NCT ID: NCT06751641

Last Updated: 2025-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-05

Study Completion Date

2025-06-05

Brief Summary

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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

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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.

Conditions

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Clinical Trial Incorporating Decentralized Elements

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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patient participating in a clinical trial incorporating decentralized elements.

participating in a clinical trial incorporating decentralized elements.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Flet, PharmD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHU Nantes

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laurent Flet, Pharm D

Role: CONTACT

+33 2 40 08 41 54

Alexandra Poinas

Role: CONTACT

0253482857

Facility Contacts

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Laurent Flet, PharmD

Role: primary

Other Identifiers

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AP_LF_DeCTris_01

Identifier Type: -

Identifier Source: org_study_id

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