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

NCT05590845 | Recruiting DMC

• 1 other identifier: Know-PND
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia Complication

Outcome Measures

Primary Outcomes (1)

• PND knowledge

  Patient knowledge regarding PND will be evaluated through 15 yes/no questions

  1 week pre-operatively

Secondary Outcomes (2)

• Baseline cognition

  1 week pre-operatively

• PND

  6 weeks post-operatively

Interventions

Survey OTHER

Patients, 65 and above, scheduled for elective total hip replacement surgery, will be invited to participate in a survey (consisting of 15 questions) testing their knowledge regarding PND. After completion of the survey, patients will receive a standard preoperative brochure on anaesthesia-related topics and delirium. T-MOCA scores will be collected (22 = perfect score; \<18 = cutoff for cognitive impairment) (through a pre-operative telephone call). Six weeks post-operatively patients will once again be called for T-moca scores. Initially a feasibility study for 1/3 of sample size will be done.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective total hip replacement surgery.

You may qualify if:

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

You may not qualify if:

• insufficient knowledge of Dutch
• known neuropsychiatric conditions

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

AZ Sint-Jan Brugge Oostende AV

Bruges, Belgium

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sarah Saxena, MD;PHD

  AZ Sint-Lucas Brugge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Saxena, MD; PHD

CONTACT

+3250452111; sarah.saxena@ulb.ac.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: January 15, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-05

Locations

BE (1)