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Completed

NCT Number: NCT06601673

Postoperative Cognitive Training to Prevent Delirium

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive training

Behavioral

The intervention consists of computer-based cognitive training in the areas of attention, processing speed, memory, emotional intelligence, reasoning and orientation. The training takes place under supervision for 120 minutes a day from the first to the fifth postoperative day.

Other names: cognitive stimulation

Listen to audio book

Behavioral

Here, an audio book is listened to for 2h daily for the first five postoperative days (or until discharge from hospital if earlier). The audio book is brought and set up by study staff.

Primary outcomes

  1. Postoperative delirium within the first five days after surgery

    Time frame: delirium screening twice daily from postoperative day 1-5

    Delirium screened twice daily using the 3D-Confusion Assessment Method (3D-CAM) for the first five days after surgery (0-4 hallmarks; hallmark 1+2 and 3+4 = delirium)

Secondary outcomes

  1. postoperative neurocognitive disorder

    Time frame: postoperative day 7 (1 week after surgery)

    delayed neurocognitive recovery (compared to baseline), measured by telephone-Montreal Cognitive Assessment (MOCA) (0-15 points; 10 points or less = cognitive impairment)

  2. postoperative neurocognitive disorder

    Time frame: 6 weeks after surgery

    compared to baseline, measured by telephone-MOCA (0-15 points; 10 points or less = cognitive impairment)

  3. postoperative neurocognitive disorder

    Time frame: 6 months after surgery

    compared to baseline, measured by telephone-MOCA (0-15 points; 10 points or less = cognitive impairment)

  4. Functional state (patient-reported)

    Time frame: 6 weeks after surgery

    compared to baseline, assessed by World Health Organization Disability Assessment (WHODAS) 2.0 questionnaire (36-item, likert scale)

  5. Functional state (measured)

    Time frame: 6 weeks after surgery

    compared to baseline, assessed by functional independence measure (FIM) (18 items with 0-7 points each, less points = less functionality)

  6. Functional state (patient-reported)

    Time frame: 6 months after surgery

    compared to baseline, assessed by WHODAS 2.0 questionnaire (36-item, likert scale)

  7. Functional state (measured)

    Time frame: 6 months after surgery

    compared to baseline, assessed by functional independence measure (FIM) (18 items with 0-7 points each, less points = less functionality)

  8. Quality of Life (by questionnaire)

    Time frame: 6 weeks after surgery

    compared to baseline, assessed by World Health Organization Quality of Life -older adults module (WHOQOL-OLD)-questionnaire (24 item, likert scale)

  9. Quality of Life (by questionnaire)

    Time frame: 6 months after surgery

    compared to baseline, assessed by World Health Organization Quality of Life -older adults module (WHOQOL-OLD)-questionnaire (24 item, likert scale)

  10. Quality of Life (by visual analogue scale)

    Time frame: 6 weeks after surgery

    compared to baseline, assessed by EQ-5D-5L- questionnaire (0-100 points, 100 points = best quality of life)

  11. Quality of Life (by visual analogue scale)

    Time frame: 6 months after surgery

    compared to baseline, assessed by EQ-5D-5L- questionnaire (0-100 points, 100 points = best quality of life)

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Postoperative Cognitive Training for the Prevention of Delirium in Older Patients

Acronym: DELtrain

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 19, 2024
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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