Clinical trial NCT06601673: Postoperative Cognitive Training to Prevent Delirium
Official title: Postoperative Cognitive Training for the Prevention of Delirium in Older Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Keywords: older patients
frailty
neurocognitive disorder
cognitive stimulation
anaesthesia
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 108
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized-controlled trial
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to test whether daily postoperative cognitive training can prevent delirium in older patients after major surgery.

The main questions to be answered is:

Can daily cognitive training reduce the rate of postoperative delirium in older patients after surgery?

Participants will be visited daily for the first 5 days after surgery and asked to take part in a tablet-based cognitive training programme for 2 hours a day (in 2 sessions).

The researchers will compare patients who receive the training with a control group of patients who listen to audio books for the same amount of time and a control group who receive standard care (no intervention).

Detailed description: The most common postoperative complication in aged patients is postoperative delirium (POD), which often progresses to permanent postoperative neurocognitive disorder (pNCD). POD and pNCD are associated with significantly increased postoperative morbidity and mortality. Prevention of POD is therefore a primary therapeutic goal in the care of elderly patients. The aim of this project is to investigate the effect of cognitive stimulation on the occurrence of POD in older patients at risk after surgery.

Patients undergoing surgery who are at least 70 years old and have an increased risk of postoperative delirium will be included. The increased risk will be assessed in a preoperative assessment as part of the anaesthetic premedication consultation. It is defined as the presence of frailty (Clinical Frailty Scale, CFS and Longitudinal Urban Cohort Study Age Function Index, LUCAS-FI), cognitive impairment (Montreal Cognition Assessment Test, MoCA) or increased morbidity (Hall Risk Analysis Index). The intervention takes the form of computer-based cognitive training in the areas of attention, processing speed, memory, emotional intelligence, reasoning and orientation. Positive effects of this training have already been shown in the treatment of mild cognitive impairment (MCI), dementia and tumour-related cognitive impairment.

The training takes place under supervision for 120 minutes a day from the first to the fifth postoperative day. It is hypothesised that postoperative cognitive training can reduce the incidence of delirium in the first five days after surgery. Secondary endpoints are the reduction of neurocognitive dysfunction at one week, six weeks and six months after surgery, maintenance of function and quality of life at six months.

In order to adjust for the stimulating effects of interacting with study staff during the study visits, a control group listening to an audio book (also brought and set up by study staff) is included in the trial.

Eligibility criteria: Inclusion criteria:

* Patients aged 70 years or older,
* planned surgery (abdominal surgery: general surgery, urology or gynaecology; spinal surgery, vascular medicine, cardiothoracic surgery, major trauma surgery),
* increased perioperative risk (frailty, cognitive impairment, multimorbidity).

Exclusion criteria:

* Unable to give consent,
* severe cognitive disorder or mental retardation (if training cannot be carried out)
* Insufficient knowledge of German

Primary outcomes:
measure: Postoperative delirium within the first five days after surgery
timeFrame: delirium screening twice daily from postoperative day 1-5
Secondary outcomes:
measure: postoperative neurocognitive disorder
timeFrame: postoperative day 7 (1 week after surgery)
measure: postoperative neurocognitive disorder
timeFrame: 6 weeks after surgery
measure: postoperative neurocognitive disorder
timeFrame: 6 months after surgery
measure: Functional state (patient-reported)
timeFrame: 6 weeks after surgery
measure: Functional state (measured)
timeFrame: 6 weeks after surgery
measure: Functional state (patient-reported)
timeFrame: 6 months after surgery
measure: Functional state (measured)
timeFrame: 6 months after surgery
measure: Quality of Life (by questionnaire)
timeFrame: 6 weeks after surgery
measure: Quality of Life (by questionnaire)
timeFrame: 6 months after surgery
measure: Quality of Life (by visual analogue scale)
timeFrame: 6 weeks after surgery
measure: Quality of Life (by visual analogue scale)
timeFrame: 6 months after surgery
Other outcomes:
Locations:
Study officials:
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