Clinical Trial Incorporating Decentralized ElementsDeCTrisNCT06751641
Survey of Adult Participants Enrolled in Decentralized Clinical Trials
An observational study of Clinical Trial Incorporating Decentralized Elements, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial Incorporating Decentralized Elements
- What is being tested?
- patient participating in a clinical trial incorporating decentralized elements.
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2024to 5 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes
Nantes, 44000
Laurent Flet, PharmD, laurent.flet@chu-nantes.fr
About this study
Official title: 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.
Read the 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.
- Being tested
- patient participating in a clinical trial incorporating decentralized elements.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient participating in a clinical trial incorporating decentralized elements.Other
participating in a clinical trial incorporating decentralized elements.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
"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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start5 Apr 2024
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Trial Incorporating Decentralized ElementsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Flet, PharmD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751641
- Sponsor's protocol ID
- AP_LF_DeCTris_01
- Acronym
- DeCTris
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Multicenter Survey of Adult Participants Enrolled in Decentralized Clinical Trials
- ClinicalTrials.gov ID
- NCT06751641
- Acronym / sponsor ID
- DeCTris / AP_LF_DeCTris_01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient participating in a clinical trial incorporating decentralized elements.participating in a clinical trial incorporating decentralized elements. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Flet, PharmD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Trial Incorporating Decentralized Elements, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Flet, Pharm D (+33 2 40 08 41 54, laurent.flet@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.