Survey of Adult Participants Enrolled in Decentralized Clinical Trials (DeCTris)

January 14, 2025 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The target population includes adults participating in traditional clinical trials for drugs that could adopt decentralized elements in the future. Eligible participants are patients or healthy volunteers enrolled in interventional trials evaluating one or more drugs, regardless of pathology, receiving treatments at the investigative site and/or their residence.

Examples include participants in trials for injectable drugs administered in hospitals, such as anticancer agents. However, trials with non-translatable procedures, like those involving critically ill patients in intensive care, are excluded. Anyone meeting these criteria is eligible for the DeCTris survey

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
"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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Laurent Flet, PharmD, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Estimated)

June 5, 2025

Study Completion (Estimated)

June 5, 2025

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • AP_LF_DeCTris_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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