Postoperative Cognitive Training to Prevent Delirium

NCT06601673 | Completed

• 2 other identifiers: S6-20242024-101267-BO-ff
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Postoperative Delirium

Keywords

older patients; frailty; neurocognitive disorder; cognitive stimulation; anaesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium within the first five days after surgery

  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)

  delirium screening twice daily from postoperative day 1-5

Secondary Outcomes (11)

• postoperative neurocognitive disorder

  postoperative day 7 (1 week after surgery)

• postoperative neurocognitive disorder

  6 weeks after surgery

• postoperative neurocognitive disorder

  6 months after surgery

• Functional state (patient-reported)

  6 weeks after surgery

• Functional state (measured)

  6 weeks after surgery

Study Arms (3)

Intervention

EXPERIMENTAL

Tablet-based bed-side cognitive training for 2h per day for the first five days after surgery (or until discharge from hospital, if earlier).

Behavioral: Cognitive training

Audio book

SHAM COMPARATOR

Listening to an audio book for 2h per day for the first five days after surgery (or until discharge from hospital, if earlier).

Behavioral: Listen to audio book

Standard care

NO INTERVENTION

Standard care without any intervention.

Interventions

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.

Also known as: cognitive stimulation

Intervention

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.

Audio book

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

MeSH Terms

Conditions

Emergence Delirium; Frailty; Neurocognitive Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, randomized-controlled trial

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: September 19, 2024
• Study Start: May 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 21, 2025

Record last verified: 2025-02