NCT05360199

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

January 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

April 23, 2022

Last Update Submit

April 28, 2022

Conditions

Degenerative Diseases, Spinal Cord

Keywords

PROMRecall bias

Outcome Measures

Primary Outcomes (1)

  • Median COMI score results

    Core outcome measures index. Scale 0 to 10 where 0 means the best score

    4 weeks

Secondary Outcomes (3)

  • Median ODI score

    4 weeks

  • Median EQ-5D score

    4 weeks

  • Median NDI

    4 weeks

Study Arms (2)

control group

NO INTERVENTION

no recall PROMs group ; without knowledge of previous PROMs scores

intervention group

ACTIVE COMPARATOR

recall PROMs group ; with knowledge of previous PROMs scores

Behavioral: PROMs

Interventions

PROMsBEHAVIORAL

evaluate the impact of recall bias on post proms scores

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro Hospitalar Universitário São João

Porto, Portugal

Location

Centro Hospitalar Universitário São João

Portugal, Portugal

Location

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
patients are unaware whether they are in the intervention or control group
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 23, 2022

First Posted

May 4, 2022

Study Start

January 1, 2021

Primary Completion

September 15, 2021

Study Completion

October 15, 2021

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

PT(2)