Patient and Public Involvement (PPI) in Non-pharmacological, Non-commercial Spanish Clinical Trials
NCT ID: NCT06632678
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
2024-10-15
2024-12-09
Brief Summary
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Detailed Description
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PPI is not an item of the information included on clinical trial registers. Thus, the objective of this study is to describe the percentage of non-pharmacological non-commercial Spanish trials with PPI as reported in published reports. For this reason our interest is on trials that have been completed. The published reports of interest are those that first described main trial results; those describing trial protocols. In the abscence of peer-reviewed reports, preprints will be considered. No other type of reports will be considered as valid source of information.
The study will review the trials (i.e.,interventional studies) conducted in Spain, and completed between September 01, 2009 and September 01, 2024. Five registers will be reviewed: clinicaltrials.gov, ISRCTN, DRKS, REBEC, and ACTRN. It is assumed that most of non-pharmacological non-commercial Spanish-sponsored trials will be registered in these five registers as per the information gathered from a previous study on COVID-19 Spanish non-commercial trials. The published reports of all completed trials from these four registers will be searched on PubMed and Google Scholar by using the trials IDs. Corresponding authors will be contacted only in the case it is impossible to retrieve the article or preprint.
In addition to PPI, and to characterize the trials, several variables will be also captured from the articles such as trial design, number of participants, condition/indication, type of intervention, year of publication, number of citations, citations/year, whether the trial was conducted following the Declaration of Helsinki proisions, whether all authors were non-physicians, and data availability statement. In addition, where was the trial registered. We will also register the Spanish region where the sponsor was located, information that will only be used in case it is deem necessary. In other words, the information to be gathered should be captured from the published reports.
Conditions
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Study Design
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OTHER
OTHER
Interventions
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behavior, procedure, diet, exercise, device, education, and any other
Any type of intervention except pharmacological interventions (drugs, biologicals, genetics)
Eligibility Criteria
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Exclusion Criteria
ALL
Yes
Sponsors
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Hospital Universitario La Paz
OTHER
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Responsible Party
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Rafael Dal-Ré
Emeritus investigator
Principal Investigators
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Rafael Dal-Ré, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Locations
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University Hospital Fundación Jimenez Diaz
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Countries
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Related Links
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Dal-Ré R, García-Méndez E. Patient and public involvement in registered non-pharmacological non-commercial Spanish trials completed in 2009-2024: A systematic review. Medicina Clinica (Barc) 2025, 165:106964
Other Identifiers
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IIS-FJD-RDR-2024-001
Identifier Type: -
Identifier Source: org_study_id
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