Evaluating Patient Knowledge About Perioperative Neurocognitive Disorders (KNOW-PND Study)

December 3, 2024 updated by: Sarah Saxena, Université Libre de Bruxelles

Neurocognitive disorders remain one of the major perioperative complications. They are associated with delayed recovery, prolonged length of hospital stay and impacts on patients' quality of life. The incidence of PND ranges from 15-50%.

While several causes have been investigated, PND seems to be due to the non-resolution of an inflammatory cascade, making some patients more at risk than others. As such, major risk factors include old age and lower education levels.

As the global proportion of people aged 60 and above between 2015 and 2050 will increase from 12% to 22% and worldwide surgeries increases to >300 million procedures per annum the incidence of perioperative neurocognitive disorders with high morbidity and mortality will go up.

In 2015, the American Society of Anesthesiologists (ASA) launched the 'Perioperative Brain Health Initiative' to increase awareness about perioperative neurocognitive disorders. (PND) While physicians seems to be more and more aware about this condition, data regarding patient awareness are not available.

An observational, single-centre, cross-sectional survey study (with initially a feasibility study) will be conducted in patients, 65 years and above undergoing elective total hip replacement surgery at AZ Sint-Jan (Brugge, Belgium) to assess patients' basic knowledge regarding PND.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brugge, Belgium
        • Recruiting
        • AZ Sint-Jan Brugge Oostende AV
        • Contact:
          • Sarah Saxena, MD; PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients scheduled for elective total hip replacement surgery.

Description

Inclusion Criteria:

  • age 65 and above
  • ASA score 1 to 3
  • scheduled for elective hip surgery.

Exclusion Criteria:

  • insufficient knowledge of Dutch
  • known neuropsychiatric conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PND knowledge
Time Frame: 1 week pre-operatively
Patient knowledge regarding PND will be evaluated through 15 yes/no questions
1 week pre-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline cognition
Time Frame: 1 week pre-operatively
Baseline T-moca scores will be documented in order to evaluate PND presence.
1 week pre-operatively
PND
Time Frame: 6 weeks post-operatively
T-moca scores will be documented post-operatively (and compared to baseline scores) in order to evaluate PND presence.
6 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Libre de Bruxelles

Investigators

  • Principal Investigator: Sarah Saxena, MD;PHD, AZ Sint-Jan Brugge-Oostende AV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Know-PND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon reasonable request, anonymous data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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