NCT06632678

Brief Summary

Patient and public involvement (PPI) in the design and conduct of clinical trials has been encouraged for many years. Yet, there is no data available describing how many trials sponsored by non-commercial Spanish individuals or organizations have liaised with patients, relatives or caregivers and the public to consider their preferences and values in the design of trials assessing non-pharmacological interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2024

Completed
Last Updated

June 15, 2025

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

October 1, 2024

Last Update Submit

June 11, 2025

Conditions

Any Condition

Outcome Measures

Primary Outcomes (1)

  • Patient and public involvement

    Presence of a PPI statement in the published report

    Published report; Day 1

Interventions

behavior, procedure, diet, exercise, device, education, and any otherOTHER

Any type of intervention except pharmacological interventions (drugs, biologicals, genetics)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy and patients with any disease or condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Fundación Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital La Paz

Madrid, Spain

Location

Related Links

MeSH Terms

Interventions

DietExerciseEducational Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Rafael Dal-Ré, MD, PhD, MPH

    Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emeritus investigator

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 9, 2024

Study Start

October 15, 2024

Primary Completion

December 9, 2024

Study Completion

December 9, 2024

Last Updated

June 15, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)