Survey of Adult Participants Enrolled in Decentralized Clinical Trials

Recruiting

• Conditions: Clinical Trial Incorporating Decentralized Elements

• Registration Number: NCT06751641
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2024-04-05
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-06-05
• Study Completion: 2025-06-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1 day	"DCT Disposition," is an ordinal variable derived from the DeCTRis self-questionnaire. This scale has five levels, with higher scores indicating a greater willingness to participate in a Decentralized Clinical Trial (DCT). The minimum score is 1, representing the lowest willingness, while the maximum score is 5, indicating the highest willingness to participate in a DCT.

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, France