Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?

NCT ID: NCT05360199

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Degenerative Diseases, Spinal Cord

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
patients are unaware whether they are in the intervention or control group

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

no recall PROMs group ; without knowledge of previous PROMs scores

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group

recall PROMs group ; with knowledge of previous PROMs scores

Group Type ACTIVE_COMPARATOR

PROMs

Intervention Type BEHAVIORAL

evaluate the impact of recall bias on post proms scores

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PROMs

evaluate the impact of recall bias on post proms scores

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All adult patients with valid preoperative PROM scores submitted to spine surgery due to degenerative pathology from January 2019 to April 2020 at our center (spine unit of a neurosurgical department in a Portuguese university hospital) were included in the study and received PROMs questionnaires with a letter of consent.

Exclusion Criteria

* Patients without valid preoperative questionnaires were excluded from the study while patients were lost to follow-up if mail questionnaires were not completed two months after PROMs remittance or if they had submitted incomplete or invalid answers.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pedro Daniel Valente Aguiar

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Hospitalar Universitário São João

Porto, , Portugal

Site Status

Centro Hospitalar Universitário São João

Portugal, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHSJ1989

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.