Degenerative Diseases, Spinal CordNCT05360199
Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?
A study testing PROMs in people with Degenerative Diseases, Spinal Cord, run by Centro Hospitalar De São João, E.P.E. at 2 sites in Portugal.
Trial summary
To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Diseases, Spinal Cord
- What is being tested?
- PROMs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Jan 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Centro Hospitalar Universitário São João
Porto
Centro Hospitalar Universitário São João
Portugal
About this study
Official title: Are Postoperative Patient Patient Reported Outcome Measures Influenced by Recall of Preoperative Scores? - a Randomized Controlled Trial
To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias
- Conditions
- Degenerative Diseases, Spinal Cord
- Being tested
- PROMs
- Keywords
- PROM, Recall bias
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMsBehavioural
evaluate the impact of recall bias on post proms scores
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: PROMs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median COMI score results
Core outcome measures index. Scale 0 to 10 where 0 means the best score
Measured: 4 weeks
Secondary outcomes (3)
Median ODI score
Neck disability index Oswestry disability index. Scale 0 to 100 where 0 means the worst score
Measured: 4 weeks
Median EQ-5D score
EuroQol 5 D where 1 is the best score and -0,500 the worst score
Measured: 4 weeks
Median NDI
Neck disability index Scale 0 to 100 where 0 means the worst score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Jan 2021
- Primary completion15 Sep 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Diseases, Spinal CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Daniel Valente Aguiar, Centro Hospitalar De São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360199
- Sponsor's protocol ID
- CHSJ1989
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Postoperative Patient Patient Reported Outcome Measures Influenced by Recall of Preoperative Scores? - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05360199
- Acronym / sponsor ID
- CHSJ1989
- Conditions
- Degenerative Diseases, Spinal Cord
- Keywords
- PROM, Recall bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –no recall PROMs group ; without knowledge of previous PROMs scores |
| intervention group | Active comparator | Behavioral: PROMsrecall PROMs group ; with knowledge of previous PROMs scores |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROMsevaluate the impact of recall bias on post proms scores | Behavioural | intervention group |
Primary outcome
Median COMI score results
Time frame: 4 weeks
Core outcome measures index. Scale 0 to 10 where 0 means the best score
3 secondary outcomes
Median ODI score
Time frame: 4 weeks
Median EQ-5D score
Time frame: 4 weeks
Median NDI
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMs in people with Degenerative Diseases, Spinal Cord, run by Centro Hospitalar De São João, E.P.E. at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median COMI score results (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.