Implementing Dynamic Consent for Rare Disease Patients (ConsDinamico)

April 21, 2026 updated by: Luca Sangiorgi, Istituto Ortopedico Rizzoli

Biobanks, Registries and National Health Records: Modelling a Networking Strategy to Foster Research and Development and to Support the Secondary Use of Data and Samples of Rare Disease Patients: Implementing Dynamic Consent for Rare Disease Patients

The study aims to test on a cohort of rare patients a digital innovative tool to support patients/parents in the informed consent and assent process and to keep up-to-date a lawful informed and dynamic consent and to use samples and data for research purposes. This will favour their engagement in clinical studies, a step which is well known to be very demanding, particularly in the rare diseases scenario, and stimulate a bidirectional dialogue between researchers and patients/parents/legal representatives.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is organized into three main steps. Firstly, an anonymous Consent Survey, will be prepared to collect the opinions of stakeholders engaged in the RDs on strengths and weaknesses of the process of consent and assent collection. This Survey will be conducted through SurveyMonkey or similar tools, posted on websites and social media, and made available to all stakeholders (patients, carers, healthcare professionals, patient associations). Key topics like the proper consideration of paediatric specificities due to age-dependent characteristics and patient satisfaction in terms of information received during the consent/assent process will be addressed.

The survey will comprise multiple-choice and open questions. Expectations related to the use of dynamic consent, potential disbeliefs, and tools for promoting and regulating participation into future research studies (text, video) will also be evaluated. Statistical analysis on survey results, as well as sentiment analysis, will be performed.

The second step will consist of two main activities:

A) the realization of dynamic informed consent and assent templates for the processing and management of data and samples. The templates will be drafted based on the long-standing experience of the research teams and the outcomes of the Consent Survey, along with the available literature and guidelines. They will be designed in full compliance with the GDPR as implemented by the Italian legislation. Information on patients' rights, purposes of data usage, legal basis and measures taken to implement lawfulness of data processing will be included.

B) The design and establishment of an innovative digital tool (a software application) to implement the dynamic consent and allowing interaction among healthcare professionals and patients. This tool will be designed considering multiple aspects, like Consent Survey results. Firstly, this tool will guide patients and caregivers to a rapid and easy access to their consent/assent, allowing them to have a clear picture of their consented studies and consenting preferences, to possibly modify and/or withdraw their consent. Secondly, new studies will be synthetically published on the digital tool, in order to favour the patients' engagement, with a particular attention to adolescents and young adults who are more familiar with these approaches, being digital natives. RD patients may be re-contacted to be informed about any new purposes of data and sample processing. The digital tool will allow healthcare professionals to give feedback on ongoing studies and to present results in layman's terms to patients. Finally, it will be of help in critical steps of the research process, such as re-consenting procedures for minors who reach the age of legal competency. Considering all the mentioned components, the digital tool will promote a high-level of transparency. The final positive impact expected is an improved process resulting in reduced costs for both patients and the National Health System. In fact, the integration of data from multiple sources will result in increased knowledge and dissemination of correct information directly to patients thus drastically reducing misinformation, duplicate visits, and optimizing patient enrolment.

The third step of this aim is the test and validation of the dynamic consent in a cohort of rare patients. Enrolling centers, both dealing with RD patients' consent on a daily basis, will conduct a pilot study enrolling a cohort of RD patients (min. 50 subjects) during clinical routine care. This step will comprise a satisfaction questionnaire - proposed to all participating patients and carers - with the final aim of identifying pitfalls and opportunities of this innovative consenting approach, and eventually implement the digital tool according to the collected responses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All rare patients diagnosed or followed up at IRCCs istituto Ortopedico Rizzoli and Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

Description

Inclusion Criteria:

  • Patients affected by a rare disease (based on clinical or genetic findings)
  • Patients with a suspect of rare disease (based on clinical or genetic findings)

Exclusion Criteria:

  • All patients who do not meet the inclusion criteria will be excluded from the study

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Test the usability of dynamic consent in a cohort of rare patients
Time Frame: From platform establishment, an average of 1 year
Collect a satisfaction questionnaire - proposed to all participating patients and carers - aiming to aim of identifying pitfalls and opportunities of this innovative consenting approach
From platform establishment, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ammeliorate the dynamic consent platform following indications received by rare patients and their carer
Time Frame: After completion of primary outcome, an avaerage 2 months
The survey that will be circulated to the different stakeholders and the evaluation questionnaire that will be requested from the participants will allow us to gather opinions and feedback on what has been achieved, in order to evaluate and implement a model that corresponds to the existing panorama, and subsequently also to improve it in terms of use, in the light of the content collected.
After completion of primary outcome, an avaerage 2 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Ortopedico Rizzoli

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 343/2024/Oss/IOR
  • PNRR-MR1-2023-12377715 (Other Grant/Funding Number: Ministero della Salute - PNRR: M6/C2_CALL2023)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings