Patients Experiences of Early Postoperative Cognition

NCT05361460 | Completed

• 1 other identifier: 2019-02968
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study has a mixed-methods design i.e. integration of qualitative and quantitative data within a single investigation. Participants included will be patients ≥60 years that are undergoing major elective joint replacement surgery (n=40) and their relative. Patient's experience of his/her cognition will be capture by interviews on postoperative day 13-16 during the follow-up visit and after 1 year. A relative will also be interviewed once on postoperative day 13-16. Cognitive function will be measured preoperatively and on postoperative day 13-16 using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) test battery. Symptoms / discomfort will be measured pre- and postoperatively (on postoperative day 1 and 2 and at the follow up visit day 13-16) by the Swedish version of Quality of Recovery (SwQoR) and by a visual analogue scale assessing pain intensity. Biomarkers will also be collected at the same time points. The findings from the interviews will be sorted out depending on group stratification (no delayed neurocognitive recovery and delayed neurocognitive recovery). The qualitative and quantitative findings will be compared to seek for similarities and differences.

Conditions

Postoperative Cognitive Decline; Biomarkers; Postoperative Recovery; Joint Replacement Surgery

Outcome Measures

Primary Outcomes (4)

• Patients experiences of early postoperative cognitive recovery

  The opening question t: "How do you yourself experience the time after the operation compared to before? " Probing questions were asked such as "What do you mean?" and "How would you describe that?" The informants will be encouraged to speak freely about the experience. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, mood and daily activity.

  13-16 days after surgery

• Relatives experiences of patients early postoperative cognitive recovery

  Opening question : "How would you describe your relative regarding being as they used to be, being themselves, before the operation compared to the time after surgery" Probing questions were asked such as "What do you mean?" and "How would you describe that?" The informants will be encouraged to speak freely about the experience. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, mood and daily activity.

  13-16 days after surgery

• Cognitive function

  Cognitive function will be measured preoperatively and on postoperative day 13-16 using the International Study Group of Postoperative Cognitive Dysfunction (ISPOCD) neuropsychological test battery The ISPOCD battery assesses cognitive performance using four different tests, providing seven variables for analysis, including Visual Verbal Learning Test, the Concept Shifting Test, the Stroop Colour-Word Test, the Letter-Digit Coding Test and has been validated in the perioperative setting for two decades. The tests will be administered in the same sequence at each test session by the same researcher following a standardized instruction manual in order to ensure as uniform a test situation as possible. The tests will be carried out in quiet rooms and only the patient and a researcher will be present.

  13-16 days after surgery

• Quality of postoperative recovery

  The patients' quality of recovery will be measured with the Swedish Quality of Recovery (SwQoR), which measure 24 different items related to symptoms/discomfort that appear postoperatively, such as pain, anxiety, sleep difficulties, dizziness, fatigue, returning to work or usual home activities. The items are rated on 11-point numerical scales ranging from 0, "none of the time", to 10, "all of the time". Reliability and validity tests have provided evidence that it is appropriate to use SwQoR in patients undergoing surgery

  13-16 days after surgery

Secondary Outcomes (8)

• Experiences of late postoperative cognitive recovery

  1 year after surgery

• C-reactive protein (mg/L)

  13-16 days after surgery

• Interleukin-6 (pg/mL)

  13-16 days after surgery

• HMGB-1 (μg/mL)

  13-16 days after surgery

• Interleukin 1-beta (pg/mL)

  13-16 days after surgery

Study Arms (1)

patients undergoing major elective joint replacement surgery

patients ≥60 years that are undergoing major elective joint replacement surgery Exclusion criteria: a score on the mini-mental state examination (MMSE) at screening of ≤ 22 i.e. suspected dementia; \< 60 years of age; suffering from a nervous system disease; taking tranquillisers or antidepressants; underwent a surgical procedure in the previous six months; or inability to read and speak Swedish; suffering from a severe visual or auditory disorder, alcoholism or drug dependence

Other: Cognitive decline

Interventions

Cognitive decline OTHER

This is an observation study with the aim of explore patients' experiences of their early and late postoperative cognition after major orthopaedic surgery in relation to postoperative cognitive function assessed with validated neuropsychological tests, inflammatory signalling molecules and quality of postoperative recovery as well as to describe the relative's view of early postoperative cognition.

patients undergoing major elective joint replacement surgery

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing major elective joint replacement surgery at a university hospital in Sweden.

You may qualify if:

• undergoing major elective joint replacement surgery

You may not qualify if:

• a score on the mini-mental state examination (MMSE) at screening of ≤ 22 i.e. suspected dementia
• age \< 60 years
• suffering from a nervous system disease
• taking tranquillisers or antidepressants
• underwent a surgical procedure in the previous six months
• inability to read and speak Swedish
• suffering from a severe visual or auditory disorder, alcoholism or drug dependence

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Ulrica Nilsson

Stockholm, 141 83, Sweden

Location

Related Publications (1)

• Amirpour A, Bergman L, Markovic G, Liander K, Nilsson U, Eckerblad J. Understanding neurocognitive recovery in older adults after total hip arthroplasty-neurocognitive assessment, blood biomarkers and patient experiences: a mixed-methods study. BMJ Open. 2025 Jan 28;15(1):e093872. doi: 10.1136/bmjopen-2024-093872.

  PMID: 39880425 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ulrica Nilsson

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: October 17, 2019
• Primary Completion: November 9, 2021
• Study Completion: December 12, 2022
• Last Updated: January 25, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)