Implementing Dynamic Consent for Rare Disease Patients
ConditionRare Disorders
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 100
SponsorIstituto Ortopedico Rizzoli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
All patients who do not meet the inclusion criteria will be excluded from the study
Trial population
All rare patients diagnosed or followed up at IRCCs istituto Ortopedico Rizzoli and Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Online consenting
Other interventionThe design and establishment of an innovative digital tool (a software application) to implement the dynamic consent and allowing interaction among healthcare professionals and patients
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Test the usability of dynamic consent in a cohort of rare patients
Collect a satisfaction questionnaire - proposed to all participating patients and carers - aiming to aim of identifying pitfalls and opportunities of this innovative consenting approach
Time frame
From platform establishment, an average of 1 yearSecondary outcomes
1
Ammeliorate the dynamic consent platform following indications received by rare patients and their carer
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.
Time frame
After completion of primary outcome, an avaerage 2 monthsLocations
Sponsors and contacts
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Istituto Ortopedico Rizzoli
Lead sponsor
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: